HRPP Policies and Procedures

The policy manual for human subjects research at UNMC.

Table of Contents

Section 1: General Human Research Protection Program Polices

1.1 Human Research Protection Program

1.2 Authority Granted by the Organization

1.3 UNMC Serving as Central IRB

1.4 UNMC Ceding Review to an External Central IRB

1.5 Requirements for Research Conducted at International Sites

1.6 IRB Composition, Leadership, Qualifications, & Responsibilities

1.7 IRB Member, Consultant, Staff COI Identification & Management

1.8 Investigational Activities Requiring IRB Review & Approval

1.9 Resources Necessary to Protect Subjects

1.10 Scientific and Other Committee Review of Research

1.11 HRPP Access to Legal Counsel

1.12 Sponsored Research

1.13 Compliance with ICH-GCP Guidelines

1.14 Research Subject to Department of Defense Regulatory Requirements

1.15 Research Subject to Department of Justice Regulatory Requirements

1.16 ORA Record Keeping Requirements

1.17 Retention of Research Records

1.18 Review and Approval of HRPP Policies and Procedures

1.19 IRB Signature Authority

1.20 Community Involvement in Research & Outreach Activities

1.21 Post-Approval Monitoring of Research

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

1.23 HRPP Training Requirements and Opportunities for Research Personnel

1.24 HRPP Training Requirements for IRB Members

1.25 Financial Conflicts of Interest

1.26 PI Qualifications & Responsibilities

1.27 Research Personnel Qualifications and Responsibilities

1.28 External Investigator Assurance

1.29 ClinicalTrials.gov Reporting

1.30 Use of the Rapid Response IRB

1.31 Observers at IRB Meetings

1.32 Confidentiality of the Review Process

Section 2: Process of Review

2.1 Submission of Items for Review by the IRB

2.2 Full IRB Review

2.3 Expedited Review

2.4 IRB Review of Changes in Previously Approved Research

2.5 Criteria for IRB Approval

2.6 Exempt Research

2.7 Continuing Review of Research

2.8 Limited IRB Review

2.9 Closure of On-Going Research

Section 3: Special Issues

3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI

3.2 Data and Safety Monitoring

3.3 Privacy Interests and Confidentiality of Research Data

3.4 Use of Protected Health Information in Research

3.5 Subject Recruitment Through Advertisements

3.6 Subject Recruitment Through Direct Invitation

3.7 Finder’s Fees and Recruitment Bonuses

3.8 Research Subject Compensation

3.9 Contraception Requirements

3.10 Pregnancy Testing

3.11 Collecting Data from Pregnant Partners of Research Subjects

3.12 Ethical Access

3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials

3.14 Phase I and First-in-Human Studies

3.15 Managing Radiographic Incidental Findings in Human Subjects Research

Section 4: Vulnerable Populations

4.1 Additional Protections for Vulnerable Populations

4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)

4.3 Research Involving Prisoners

4.4 Research Involving Children

4.5 Local 407 Panel Review of Pediatric Research

4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

4.7 Research Involving Employees of the Organization and Students as Subjects

Section 5: Informed Consent

5.1 Obtaining Informed Consent from Research Subjects

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

5.3 Use of a Telephone Consent Process

5.4 Waiver of the Requirement to Obtain Signed Consent Form

5.5 Use of the Short Form Consent Document

5.6 Exception from Informed Consent Requirements for Emergency Research

Section 6: FDA Regulated Research/Drugs & Devices

6.1 Research Involving Investigational and Marketed Drugs

6.2 Research Involving Investigational and Marketed Devices

6.3 Humanitarian Use Device (HUD)

6.4 Emergency Use of a Test Article

Section 7: Human Biological Materials and Data Registries

7.1 Banking Human Biological Materials

7.2 Use of Human Biological Material in Research

7.3 Data Registries

Section 8: AEs, Unanticipated Problems and Compliance

8.1 IRB Review of Adverse Events and Adverse Device Effects

8.2 IRB Review of Study Related Complaints

8.3 IRB Review of Unanticipated Problems Involving Risk to the Subject or Others

8.4 Review of Noncompliance Involving the PI and Study Personnel

8.5 Noncompliance by the IRB or Other Components of the HRPP

8.6 Study Hold, Suspension, and Termination

8.7 Reporting Incidents to Institutional Officials and Federal Agencies

Section 1: General Human Research Protection Program Policies

Section 1: General Human Research Protection Program Policies

1.1 Human Research Protection Program (HRPP)

1.0 Purpose

The purpose of this policy and procedure is to provide a basic description of the Organization’s Human Research Protection Program (HRPP) through: 1) the Organization’s stated mission, 2) application of ethical principles to guide all human subject research under the oversight of the Organization, and 3) regulatory compliance with all applicable federal, state and local laws.


2.0 Policy

It is the policy of the Organization that the HRPP will ensure the rights and welfare of human subjects are protected, will evaluate and continually improve the protection of human research subjects, and will foster important human subject research in accordance with its mission.


3.0 Organization


4.0 HRPP Mission


5.0 Ethical Principles


6.0 Regulatory Compliance


7.0 Federalwide Assurance (FWA)


8.0 Written Policies and Procedures

The HRPP Policies detail the policies of the Organization and regulations governing conduct of research involving human subjects under the auspices of the Organization. Review and revision of these policies and procedures will be conducted in accordance with HRPP policy 1.18 (Review and Approval of HRPP Policies and Procedures).


9.0 Description of the HRPP

The HRPP is a comprehensive system to ensure the protection of human subjects participating in research. The HRPP consists of the IRBs listed in section 7.0 above, other review committees, administrative offices, and administrative officials as described in this policy.


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 3/27/2018 - revision not documented

 Revised: 9/4/2018 - revision not documented

 Revised: 5/3/2021 - Added IRB-05 (SIRB) (IRB00012770) in section 7.2.5; revised sections 6.1.1.3 and 6.1.1.6 to delete and clarify references to transition to Revised Common Rule; cClarified that section 9.6.1 does not represent a complete list of ancillary committees; clarified that the Pharmacy Manager or other representative of the CHMC Pharmacy is a member of the Joint Pediatric IRB (section 9.7.3.2.2); deleted specifics of job requirements for IRB Administrators and ORA Staff (redundant to job descriptions); simplified and clarified training requirements for IRB Administrators and ORA Staff. Notification: not documented

 Revised: 1/16/2023 - Added IRB-06; specified Children’s Hospital & Medical Center (CHMC) includes Children’s Physician practice offices; clarified that Children’s Hospital and Medical Center and it’s wholly owned Children’s Physician’s Practice offices operates under the authority of the FWA held by that legal entity; deleted comment that IO is the Associate Vice-Chancellor for Clinical Research; specified that the IO is an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program; replaced “Administrator” with “Analyst”; minor stylistic changes. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/19/2023

Section 1: General Human Research Protection Program Policies

1.2 Authority Granted to the IRB by the Organization

1.0 Purpose

The purpose of this policy and procedure is to describe the authority granted by the Organization for the IRBs operating within the HRPP.


2.0 Policy

It is the policy of the Organization that:


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016)

 Revised: 3/9/2018 - revision not documented

 Revised: 5/28/2021 - Clarified who may act as an expedited reviewer (section 2.2.2); added that the IRB or ORA may be charged with review of other research activities, and granted authority to do so; deleted reference to other specific committees and activities. Notification: not documented

Section 1: General Human Research Protection Program Policies

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for the UNMC IRB to serve as the Single IRB (SIRB) for multisite research.


2.0 Policy


3.0 Definitions


4.0 UNMC IRB, Relying Institution, and Lead PI Responsibilities


5.0 Procedures


DOCUMENT HISTORY:

 Undocumented activity: 4/4/2016

 Undocumented activity: 3/27/2018

 Revised: 10/21/2021 - Major revisions in format; content revised to be consistent responsibilities described in HRPP 1.4, Notification: not documented

 Revised 8/25/2023 - Added additional responsibility for UNMC HRPP regarding review of relying institution COI management plan (section 4.1.1.1). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.4 UNMC Ceding Review to an External Central IRB

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for the UNMC IRB to cede review to an external IRB.


2.0 Policy


3.0 Definitions


4.0 External IRB, UNMC IRB, and PI Responsibilities


5.0 Procedures


Addendum 1: UNMC Required Consent Form Language

Title: As the IRB of record allows, the consent Form should appear on UNMC/ Nebraska Medicine letterhead for easy identification as a research consent form. The UNMC IRB number should appear in the consent.

Contraception/Pregnancy Language for FDA regulated research: Insert appropriate contraception language based on FDA Pregnancy and Lactation Labeling Rule and/or FDA Use-In-Pregnancy category, as per HRPP Policy 3.9 Contraception Requirements.

Category A and Some Category B Drugs (do not require contraception) It is possible that the medicines used in this study could injure a fetus if you or your partner becomes pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions.

Category B, C and D Drugs It is possible that the medicines used in this study could injure a fetus if you or your partner becomes pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions.

You may want to discuss this with others before you agree to take part in this study. If you wish, we will arrange for a doctor, nurse, or counselor who is not part of this study to discuss the potential risks and benefits with you and anyone else you want to have present.

Because of the potential risks, you or your partner must not become pregnant while participating in this study. Women must have a negative pregnancy test before entering the study (and before each treatment as appropriate).

If you are sexually active and can get pregnant, or can get your partner pregnant, you must use ONE (or TWO) appropriate method of birth control every time you have sex, or you must not have sex.

You can get additional information about methods to avoid pregnancy by calling the UNMC Research Subject Advocate's Office at (402) 559-6941.

You or your partner will need to continue to avoid pregnancy for X months after finishing the research.

Should you or your partner become pregnant while on this study, you should immediately notify the study personnel. The investigator will assist you in finding appropriate medical care. The investigator also may ask to be allowed to continue getting information about your pregnancy. You can refuse to provide this information.

Category X drugs: Since studies of the drug in humans, or investigational or post-marketing data, have demonstrated fetal risk, contraception is required and the language must be at least as protective as Category D language above. Often the sponsor and/or FDA require inclusion of specific language relating to fetal risk, monitoring for pregnancy and prevention of pregnancy in the consent form. The language cannot be modified.

Costs to Subject (required for all clinical trials): You will have to pay any insurance deductibles and co-payments. If you want to speak with someone about your insurance, just tell us.

Payment:

If SSN is required for payment, then use the following standard statement:

In order to pay you, you will have to provide your social security number. You can choose not to provide this and still participate in the research but we will be unable to pay you.

If this study has a tissue bank include this standard statement:

We do not plan to pay you if any new drugs or products are made using the sample(s) you donated. It is our policy that all donated samples belong to the organization.

Subject Injury Language for greater than minimal risk research

Add the following to consent form subject injury language:

Your health and safety is our main concern. If you are injured or have a medical problem because of this study call someone listed at the end of this consent form. You can get emergency medical treatment at Nebraska Medicine. You can also go to your doctor, the nearest emergency room or call 9-1-1.

{Insert the commercial sponsor language}

We have no plans to pay for your treatment or give you any other money or compensation.

Signing this does not mean you have given up any of your legal rights.

HIPAA Language:

We also will get medical information about you (like medical record number, medical history, or the results of physical exams, blood tests, x-rays or other medical or research procedures). We call this "protected health information" or PHI. PHI is protected by a law called the HIPAA Privacy Rule. We will collect the smallest amount of PHI that we can. We will keep your PHI as confidential as possible.

By signing this consent form, you are letting us (the researchers listed on this consent form and other people involved in this research at the Organization) have access to your PHI. Your PHI will be used only for the purposes described in the section "What is the reason for doing this research study?"

You can change your mind and tell us to stop collecting your PHI for use in this research at any time by writing to the principal investigator. We can still use the PHI we have already collected. If you tell us to stop collecting your PHI, you will have to stop being in this research.

We may share your PHI with other groups listed below:

The UNMC Institutional Review Board (IRB)

Institutional officials designated by the UNMC IRB

The HHS Office for Human Research Protections (OHRP)

We may share your PHI with other groups listed below. The HIPAA Privacy Rule requires these groups to protect your PHI.

The Food and Drug Administration (FDA) {if study involves FDA regulated drug, device, or biologic}

National Institutes of Health (NIH) {if study is funded by the NIH}

Researchers at insert the name of the institution(s) involved in the study if this is a multi-institution study where PHI will be shared with other researchers

Your health insurance company {if the Institution expects third party payers to pay for clinical procedures performed during the course of the research}

The Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC) {if the research involves patients with cancer}

We may share your PHI with other groups listed below. These groups are NOT required by HIPAA to protect your PHI. If we share your PHI with these other groups they may share it with others who also do not have to protect it under HIPAA:

{insert name of sponsor}, which sponsors this research and may pay the Organization to do this research

{insert name of CRO} which has been hired by the sponsor to help run the research

The Data and Safety Monitoring Committee (DSMC)

{name of NCI National Cooperative Group}

The National Cancer Institute's (NCI) Clinical Trial Reporting Program

NOTE: Choose one of the statements that appropriately represents your study:

You are letting us use and share your PHI for as long as the research is going on.

Or:

You are letting us use and share your PHI for as long as the sponsor needs so it can get approval from the FDA.

Or:

There is currently no plan to end this study. You are letting us use and share your PHI for as long as we want.

What are your rights as a research participant?

You have rights as a research subject. These rights have been explained in this consent form and in The Rights of Research Subjects that you have been given. If you have any questions concerning your rights, or want to discuss problems, concerns, obtain information or offer input, or make a complaint about the research, you can contact any of the following:

The investigator or other study personnel

Institutional Review Board (IRB)

Telephone: (402) 559-6463.

Email: IRBORA@unmc.edu

Mail: UNMC Institutional Review Board, 987830 Nebraska Medical Center, Omaha, NE 68198-7830

Research Subject Advocate

Telephone: (402) 559-6941

Email: unmcrsa@unmc.edu


Addendum 2: UNMC HRPP Policies to be followed by institution investigators

Process of informed consent, including remote consent and electronic signature, documentation of consent and use of Short Form; per HRPP policies 5.1 (Obtaining Informed Consent From Research Subjects), 5.3 (Use of a Remote Consent Process), and 5.5 (Use of the Short Form Consent Document)

Research Data Privacy, Confidentiality, use of PHI, and Data Safety Monitoring; per HRPP policies 3.2 (Data and Safety Monitoring), 3.3 (Privacy Interests and Confidentiality of Research Data), and 3.4 (Use of Protected Health Information in Research).

Subject Identification and Recruitment, including Ethical Access; per HRPP policies 3.5 (Subject Recruitment through Advertisements), 3.6 (Subject Recruitment through Direct Invitation), 3.7 (Finder’s Fees and Recruitment Bonuses), and 3.12 (Ethical Access).

Subject payment; per HRPP policy 3.8 (Research Subject Compensation).

Pregnancy testing, pregnant partner, and contraception; per HRPP policies 3.9 (Contraception Requirements) and 3.10 (Pregnancy Testing).

Investigator and research staff training; per HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel).

Research involving subjects with impaired decision-making capacity; per HRPP policy 4.6 (IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity).


DOCUMENT HISTORY:

 Written: not documented (Approved: not documented)

 Revised: 5/30/2017 - revision not documented

 Revised: 2/28/2018 - revision not documented

 Revised: 10/21/2021 - Added organizational policy to comply with Common Rule and NIH requirements regarding use of a single IRB; deleted redundant policy statements; clarified requirements for accreditation of reviewing IRB; modified types of research not eligible for use of external IRB; moved list of UNMC policies that must be followed to addendum 2; clarified responsibilities of external IRB, UNMC IRB and investigators; clarified ORA and IRB procedures; clarified required documents to be submitted by PI; other minor reorganization of policy; added Addendum 1 and 2. Notification: not documented

 Revised: 12/8/2022 - modified addendum 1 to correct inconsistencies with Consent Form template (Subject Injury, HIPAA, and Participant Rights sections) {Approved Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 8/25/2023 – Added responsibility for UNMC HRPP regarding notification of reviewing IRB when local policies that impact IRB review are updated (section 4.2.11).

Section 1: General Human Research Protection Program Policies

1.5 Requirements for Research Conducted with International Sites

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for research conducted with international sites. For the purposes of this policy, “Research conducted with International Sites” (international research) is defined as (1) research conducted by a faculty member, staff, student, or other representative of the Organization at an international site, or (2) research conducted by external investigators under the direction of a faculty member, staff, student, or other representative of the Organization, or (3) research where an investigator receives identifiable private information or identifiable biospecimens from an international site.


2.0 Policy

It is the policy of the Organization that:


3.0 Investigator Responsibilities


4.0 ORA Responsibilities


DOCUMENT HISTORY:

 Written: 1/13/2016 (Approved: 1/13/2016) - original author not recorded

 Revised: 2/9/2018 - revision not documented

 Revised: 12/8/2022 – revised title to stress international research includes work with international sites in addition to work at those sites; added specific definition to include research where an investigator receives or sends human biological or data from or to an international site; corrected reference to UNMC policy shipping of Hazardous Materials; corrected reference to Department of Environmental Health & Safety; added UNO policies; deleted requirement for formal reliance agreement (section 5.1.1.6); deleted references to sections effective after the revision of the Common Rule; revised section 2.3 so that exception may be granted by the Executive Chair rather than IO. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 12/12/2022

 Revised 5/9/2023 – Revised definition of international research to remove sending human biological material or data; reformatted to separate investigator responsibilities and IRB/ORA responsibilities; clarified ORA responsibilities when considering exempt international research. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB composition, leadership, member qualifications, and responsibilities.


2.0 Policy

It the policy of the Organization that the membership of its IRBs will satisfy requirements of 45 CFR 46.107 and 21 CFR 56.107, and will include an appropriately diverse mixture of backgrounds, gender, and race/ethnicity.


3.0 Composition of the IRBs


4.0 IRB Leadership


DOCUMENT HISTORY:

 Written: 4/11/2016 (Approved: 4/11/2016) - original author not documented

 Revised: 3/27/2018 - revision not documented

 Revised: 7/29/2021 - Removed redundant material; removed references to pre-2019 Common Rule; clarified items included in roster of IRB members; clarified responsibilities of IRB chairs and Vice-Chairs.

 Revised: 4/15/2022 - Clarified that an IRB administrator serving as a voting or alternate member of the IRB may not serve as primary reviewer for a protocol for which he/she primary administrator (section 4.5.9.2). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 7/14/2022 - Revised to clarify that consultants are not officially appointed by EC; removed reference to Compliance Officer as a consultant; clarified that IRB Administrators appointed as IRB members or alternate members by the IO, in consultation with the IRB Executive Chair; simplified designation of IRB administrators as scientists or non-scientists; specified that IRB administrators must have at least 2 years-experience with the ORA or another IRB, and must be approved by the IRB Executive Chairperson, before they can act as an expedited reviewer. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 10/11/2022 - Clarified that a consultant or a knowledgeable board member may provide information to the IRB regarding Community Based Participatory Research (section 3.9). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/15/2022

Section 1: General Human Research Protection Program Policies

1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the identification and management of IRB member, consultant, staff and guest potential conflicts of interest.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Procedures for identification and management of conflict of interest by members and consultants


5.0 Procedures for identification and management of conflict of interest by IRB staff


6.0. Procedures for identification and management of conflict of interest by guests at the IRB meeting


DOCUMENT HISTORY:

Written: 12/29/2015 (Approved: 12/29/2015) - original author not recorded

 Revised: 2/1/2018 - revision not documented

 Revised 10/10/2022 - Added identification and management of COI for a guest at IRB meeting; clarified that any financial interest by IRB members, consultants, staff and guests at the meeting is considered a significant financial interest within the context of this policy; clarified definitions of financial and non-financial COI; added definition of guest; clarified timing of disclosure of COI by IRB members; added IRB member whose only conflict is that he/she is participating personnel on a protocol may serve as protocol reviewer, and may participate in the discussion regarding the protocol, may remain in the meeting room during the vote, but will abstain from voting; added that IRB staff with COI must leave room during the discussion and voting phases of the review of the protocol in which they have a conflict; deleted option for member with COI to request exception from recusal; stylistic changes for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Boards voted to approve: 11/22/22; 12/1/22; 12/9/22; 12/15/22

Section 1: General Human Research Protection Program Policies

1.8 Investigational Activities Requiring IRB Review and Approval

1.0 Purpose

The purpose of this policy is to describe the investigational activities that require IRB approval.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 HRPP Classifications of Human Subject Research


5.0 Activities Which Are Not Human Subject Research

Note: Publishing or presenting the results of a quality improvement project does not necessarily mean the activity is research. Descriptions of non-research activities (e.g., an account of the quality improvement project) are often an expected outcome of the project. On the other hand, re-analysis of the data derived from the quality improvement project in order to prove or disprove a hypothesis is research. Depending on whether or not subject identifiers are maintained, it may qualify as exempt research.


6.0. Other Activities Deemed Not Research

Other activities specifically defined in 45 CFR 46.102(l) are deemed “not research.” These activities include:


7.0 Determination of When an Activity Constitutes Human Subject Research


8.0 Type of Review


DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

 Revised: 9/27/2017 - revision not documented

 Revised: 3/3/2018 - revision not documented

 Revised: 2/18/2019 - revision not documented

 Revised: 10/4/2022 - Removed references to “after effective date of revised regulations”; deleted redundant descriptions of activities deemed not research per 46.102(l); simplified section 7.0 to remove specific IRB and ORA procedures {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/16/2022

 Revised: 2/8/2023 – revised section 7.0 to describe use of website NHSR Decision Tool. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 2/15/2023

 Revised: 5/9/2023 – clarified characteristics of Student Projects (section 5.6); added description and defined parameters of Pilot Testing (section 5.7).{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.9 Resources Necessary to Protect Subjects

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for resources that are necessary for human subject protection, care of research participants, and safety during the conduct of research.


2.0 Policy


3.0 PI and Certifier Obligation


4.0 IRB Review of Resources


DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not documented

 Revised: 9/27/2017 - revision not documented

 Revised: 3/3/2018 - revision not documented

Section 1: General Human Research Protection Program Policies

1.10 Scientific and Other Committee Review of Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for scientific and scholarly merit review, and review by other component committees of the HRPP, of all human subject research protocols (see HRPP policy 1.9 Review of Resources Necessary to Protect Subjects) conducted under the jurisdiction of the UNMC IRB.


2.0 Policy


3.0 Department, Division, School, College, or Institute Review of Scientific Merit


4.0 Reviews by Other Components of the HRPP

Depending upon the nature of the research, proposals may be subject to additional review and approval by one or more of the following groups. None of these committees has the authority to approve human subject research to begin that has not yet been approved, or has been disapproved, by the IRB, as per HRPP policy 1.2 (Authority Granted to the IRB by the Organization).


DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

 Revised: 2/12/2018 - revision not documented

 Revised: 5/17/2021 - Clarified responsibility for, and process of, scientific review; clarified responsibilities of the P&T Committee, and process of review; simplified description of function and activities of IDRC; clarified responsibilities of the IBC regarding human subject research; updated description of activities of CCTR; added reference to “other committees as directed by institution and/or IO”; clarified responsibilities of ORA vs IRB

 Revised 8/1/2023: - Corrected typographic errors; changed “administrator” to “analyst” {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.11 HRPP Access to Legal Counsel

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for HRPP access to legal counsel for the purpose of interpreting federal, state, and local law as needed.


2.0 Policy

It is the policy of the Organization that the HRPP will have ready access to legal counsel in order to ensure the correct interpretation and application of federal, state, and local law. When laws or regulations are issued or amended, the appropriate component of the HRPP will be advised in a timely manner and any necessary actions taken in accordance with effective dates.


3.0 Procedures


DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

Section 1: General Human Research Protection Program Policies

1.12 Sponsored Research

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for research sponsored by an external funding agency or commercial sponsor.


2.0 Policy

It is the policy of the Organization that in sponsored research, both the Sponsor and the Organization have obligations to protect research participants and ensure that the research is conducted in accordance with the Organization’s ethical standards, and in full compliance with all applicable HRPP policies, federal regulations for protection of human subjects, state and local laws and regulations, and University of Nebraska Board of Regents By-Laws.


3.0 Definitions


4.0. Investigator Responsibilities


5.0. Sponsor Responsibilities


6.0. Organization Responsibilities


7.0. ORA and/or IRB Responsibilities:


Addendum I

Contract or Funding Arrangement: The contract or funding arrangement must include a clear definition of the Sponsor’s responsibility for the payment of medical care for research participants who experience a research related injury, including (1) non-exculpatory limitations the sponsor has imposed on the extent of payment for medical care, and (2) the location(s) where medical care can be obtained. This statement of responsibility must be consistent with the “Compensation in Case of Injury” clause found in the ICF. Indemnification language in the contract must not compromise the rights and welfare of research subjects. The contract must not include a financial bonus or financial penalty specifically linked to subject recruitment efforts (HRPP policy 3.7 Finders Fees and Recruitment Bonuses). The contract must not include any direct personal payments or other form of compensation from the Sponsor to investigators and other study personnel. The contract must not include any requirements which would cause the Organization to violate the HIPAA Privacy Rule. When PHI is provided to the Sponsor the Sponsor must refrain from using PHI to recruit subjects or advertise additional studies to subjects, refrain from using the PHI for marketing or market research and place the same restrictions on any third party to whom the Sponsor discloses PHI. The contract must not include any prohibition from retaining a copy of the data generated during the study at UNMC or other study sites under the jurisdiction of the UNMC IRB. The contract must not include any restrictions on publication of the results of the research which violate the University of Nebraska Board of Regents Policy (RP-3.2.8 (section 7; page 103)).


DOCUMENT HISTORY:

 Written: 5/6/2022 (Approved: 5/6/2016) - original author not recorded

 Revised: 2/8/2018 - revision not documented

 Revise: 8/17/2023 – added definitions and language regarding subawards and subcontracts; reorganized to define specific responsibilities; provided specific AAHRPP requirements regarding contracts. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.13 Compliance with ICH-GCP Guidelines

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for compliance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) E6 Guidelines.


2.0 Policy


3.0 Procedures


4.0 ICH GCP Requirements


DOCUMENT HISTORY:

 Written: 1/25/2016 (Approved: 1/25/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

Section 1: General Human Research Protection Program Policies

1.14 Research Subject to Department of Defense Regulatory Requirements

1.0 Purpose

The purpose of this policy and procedure is to specify the Organization’s requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Defense (DoD) and the U.S. Department of the Navy (DoN).


2.0 Policy


3.0 Definitions


4.0 Procedures


DOCUMENT HISTORY:

 Written: 4/13/2016 (Approved: 4/13/2016) - original author not recorded

 Revised: 3/3/2018 - revision not documented

 Revised: 6/4/2021 - Reorganized; extensive revisions based on revisions to DoDI 3216.02, 15 April 2020, SECNAVINST 3900.39E, 29 May 2018

 Revised: 8/7/2023 - added 2.3.15 and 2.3.16; revised 2.3.4 per DoDI 3216.02, April 15, 2020 Change 1, June 29, 2022 {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.15 Research Subject to Department of Justice Regulatory Requirements

1.0 Purpose

The purpose of this policy and procedure is to specify the Organizations requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Justice (DoJ) and the Federal Bureau of Prisons (BoP).


2.0 Policy


3.0 Definitions [28 CFR 46.102]


4.0 Procedures


DOCUMENT HISTORY:

 Written: 4/20/2016 (Approved: 4/20/2016) - original author not recorded

Section 1: General Human Research Protection Program Policies

1.16 ORA Record Keeping Requirements

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for maintenance of documentation of IRB and ORA activities. Retention of records by the investigator is described in HRPP policy 1.17 (Retention of Research Records).


2.0 Policy

It is the policy of the Organization that the ORA will maintain documentation of all IRB activities in accordance with 45 CFR 46.115 and 21 CFR 56.115 as applicable. Records for each protocol will be organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of the protocol.


3.0 Procedures


DOCUMENT HISTORY:

 Written: 4/7/2016 (Approved: 4/7/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised: 10/11/2022 - typo corrected in 3.2.27.2/3.2.27.3 - rational to rationale {by Robert Lewis, IRB Assoc}

 Revised: 7/22/2022 - Extensive revisions; removed list of items to be retained, and substituted appropriate regulatory language; specified location of retained records; clarified duration of retention of paper records (per HRPP 1.17). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/10/2022

Section 1: General Human Research Protection Program Policies

1.17 Retention of Research Records

1.0 Purpose

The purpose of this policy is to describe the requirements for retention of research records by the investigator.


2.0 Policy

It is the policy of the Organization that all research records must be maintained and stored securely, in accordance with Nebraska State Law, for at least seven years beyond the termination of the study or longer as required by sponsors.


3.0 Required Records


4.0 Department Retention of Records


ADDENDUM

Under the HIPAA Privacy Rule, subjects have the right to ask the Organization for an accounting of certain disclosures of their identifiable health information for a period dating 6 years from the date of the last covered disclosure. To ensure that the Organization can meet this accounting requirement, investigators must retain study records, along with records of all disclosures of study information, for at least 7 years after either of the following (whichever is later) (1) the last subject has completed his or her participation in the study; or (2) the date of the last disclosure of identifiable health information from study records, if disclosures continue after all subjects have completed the study. {45 CFR 164.528}

DHHS regulations require that, “records relating to research which is conducted shall be retained for at least 3 years after completion of the research.” {45 CFR 46.115(b)}

FDA requires that sponsors and investigators participating in research subject to IND regulations retain “records and reports required by this part for 2 years after a marketing application is approved for the drug; or if an application is not approved for drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA so notified.” {21 CFR 312.57(c)} FDA requires that sponsors and investigators participating in research subject to IDE regulations retain the records “for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated of completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.” {21 CFR 812.140(d)}


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded (original policy #3.5)

 Revised: 2/2/2018 - revision not documented

 Revised: 2/18/2019 - revision not documented

 Revised: 4/15/2022 - deleted reference to Nebraska law; clarified that records must retain identifiers; revised to delete list of items to be retained; specified responsibility of faculty advisor for student conduct research; added regulatory requirements as addendum {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 6/30/2022 - revised to state that records associated with exempt research only need to be retained for three years; added statement regarding records retention for volunteer faculty (section 4.1.2) {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/14/2022

Section 1: General Human Research Protection Program Policies

1.18 Review and Approval of HRPP Policies and Procedures

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the review and approval of HRPP policies.


2.0 Policy

It is the policy of the Organization to continually assess the adequacy of existent policies in consideration of new information and Organizational requirements that may affect the HRPP, including federal, state, and local laws, regulations, and guidance, as well as emerging ethical and scientific issues.


3.0 Review of HRPP Policies


4.0 Full IRB Review of Draft HRPP Policies


5.0 Organizational Notification of Changes to HRPP Policies


DOCUMENT HISTORY:

 Written: 1/25/2016 (Approved: 1/25/2016) - original author not recorded

 Revised: 1/28/2018 - revision not documented

 Revised: 6/30/2022 - Revised required frequency of policy review; revised number of IRBs; clarified order of review and approval of policies by boards and IO; removed requirement for “read receipt” for email votes; clarified mechanism for notifying ORA staff. {Approved: 7/2/2022 Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/14/2022

Section 1: General Human Research Protection Program Policies

1.19 IRB Signature Authority

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for granting signature authority for Office of Regulatory Affairs (ORA) and IRB correspondence.


2.0 Policy

It is the Organization’s policy that the IRB Executive Chair, the IRB Chairs and Vice-Chairs and qualified IRB staff will have appropriate signature authority on behalf of the ORA and the IRB.


3.0 Procedures

The following individuals have signature authority as indicated below:


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 1/2/2018 - revision not documented

 Revised: 10/7/2022 – clarified that Exec Chair can sign authorization agreements after review and approval by the IO; stylistic changes; correct typos; rename Office Assistant as IRB Associate. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/14/2022

Section 1: General Human Research Protection Program Policies

1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)

1.0 Purpose

The purpose of this policy is to describe the Organization’s outreach activities to enhance the public’s understanding of research, obtain feedback about any community concerns, disseminate results of research conducted by the Organization and encourage involvement of the community in the research process.


2.0 Policy

It is the policy of the Organization that:


3.0. Outreach Activities for Education of the Community


4.0. Outreach activities specifically directed at community education regarding current and proposed research studies.


5.0. Outreach activities directed at involvement of the community in Research Design, Implementation, and Analysis of Research Results (CBPR).


6.0. Evaluation of Outreach Activities


DOCUMENT HISTORY:

 Written: 4/14/2016 (Approved: 4/14/2016) - original author not recorded

 Revied: 2/12/2018 - revision not documented

 Revised: 6/2/2023 – amended numbering of section 3.2, made formatting and syntax corrections, updated sections 3.2, 3.3, and 3.4 to reflect current materials.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 7/6/2023 – extensive modifications and additions to sections 3, 4, 5, and 6.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.21 Post-Approval Monitoring of Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for post approval monitoring of research.


2.0 Policy


3.0 Post Approval Monitoring Program Objectives


4.0 Procedures


DOCUMENT HISTORY:

 Written: 12/14/2015 (Approved: 12/14/2015) - original author not recorded (original title “QUALITY IMPROVEMENT ASSESSMENT FOR THE CONDUCT OF RESEARCH”)

 Revised: 2/28/2018 - revision not documented

Section 1: General Human Research Protection Program Policies

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for assessment of the quality, effectiveness, efficiency and support of the Organization’s HRPP in carrying out its mission to ensure protection of human subjects and compliance with all applicable federal, state and organizational requirements.


2.0 Policy

It is the policy of the Organization that there will be an ongoing assessment of the HRPP, as well as a comprehensive annual HRPP assessment. These assessments are designed to ensure: 1) that the HRPP is fully capable of protecting the rights and welfare of research subjects; and 2) the HRPP will continue to evolve and improve in its effectiveness and efficiency.


3.0 Procedures


DOCUMENT HISTORY:

 Written: 4/14/2016 - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised: 8/30/2022 - Changed title of policy; clarified frequency of assessments of minutes for various boards; revised and clarified methods of feedback to the ORA/IRB by stakeholders; clarified process and basis for evaluation of Chairs and Vice-Chairs, and IRB members; clarified process of evaluation of IRB administrators and staff; clarified process and goals of Annual HRPP Assessment. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/30/2022

Section 1: General Human Research Protection Program Policies

1.23 HRPP Training Requirements

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements and opportunities for training for all personnel involved in conducting human subject research.


2.0 Policy

It is the policy of the Organization that all personnel involved in the conduct of human subject research under the oversight of the UNMC IRB will be qualified through initial and continuing education in order to fulfill their responsibility to protect the rights and welfare of human subjects.


3.0 Definitions


4.0 Required Training


5.0 Additional (Optional) Training


6.0 Procedures for Assessing Training Requirements


7.0 Procedures for Maintaining Training Records

The ORA maintains all training records for CITI Training and didactic activities described above, and maintains copies of materials sent by mail or email or posted on the website.


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 6/28/2018 - revision not documented

 Revised: 8/31/2021 - Described basic vs additional modules for CITI courses; described requirement to complete additional modules based on type or research and subject population; clarified location of UNMC HRPP Policies manual; correction of references to sections within this and other policies; delineated required vs optional training; deleted training no longer offered; minor stylistic changes and clarification

 Revised: 6/30/2022 - clarification or requirements for CITI biomedical course (section 4.1.4.1) {Approved: 7/2/2022 - Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 8/17/2022 - clarification regarding expiration of CITI training for personnel on an active protocol (section 4.1.10) {Approved - Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/16/2022

Section 1: General Human Research Protection Program Policies

1.24 HRPP Training Requirements for IRB Members

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for training for IRB members and alternates.


2.0 Policy

It is the policy of the Organization that IRB members and alternates will be qualified through initial and continuing education in order to fulfill their responsibility to protect the rights and welfare of human subjects.


3.0 Definitions


4.0 Initial Training and Orientation

5.0 Continuing Education


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 2/1/2018 - revision not documented

 Revised: 7/14/2022 - Deleted list of specific documents to be supplied to new IRB members; added requirement that full orientation of new members must be completed before the new member may serve as a reviewer or count as a voting member; clarified that completion of required continuing education will be assessed at the time of the annual evaluation of IRB members in terms of general regulatory knowledge; deleted requirement that ORA maintain initial and continuing education training records. {Approved: Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/15/2022

Section 1: General Human Research Protection Program Policies

1.25 Financial Conflicts of Interest

1.0 Purpose

The purpose of this policy is to describe the Organization’s procedures for identification, management, and minimization or elimination of financial conflict of interest (COI) of responsible personnel, senior administrators, and the Organization itself that could influence the conduct of research or the integrity of the HRPP.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Procedures for Disclosure of Potential COI


5.0 COI Management Plan

6.0 Review of COI Management Plans



7.0 Management of COI in Research Conducted by Subgrantees, Contractors, and Collaborators


8.0 Documentation of COI Management


9.0 Management of Organizational Financial COI


DOCUMENT HISTORY:

 Written: 4/14/2016 (Approved: 4/14/2016) - original author not recorded (previous policy #3.12)

 Revised: 6/13/2018 - revision not documented

 Revised 12/8/2022 - Clarified that the ORA is only responsible for assuring the organization has adequate policies and procedures to ensure responsible personnel are appropriately trained (as opposed to the actual training); revised definition of covered persons to match that in HRPP 1.7; clarified definition of Organizational COI; delete specific FDA requirements under 21 CFR 54.4; clarified that, for multi-institution research where the UNMC IRB is the reviewing IRB, the COI Management plan may be generated by the relying institution; clarified that management plan may (but not “must”) include disclosure; clarified process for management plans associated with non-significant FCOI; deleted list of possible management options by COIC; clarified process for expedited review as opposed to convened IRB review; clarified process for review of management plans when organization relies on an external IRB; added requirement that initial review of non-exempt human subject research for which an organizational COI has been identified will be performed by the convened IRB; added “senior organizational officials” to definition of Organizational COI.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board voted and approved: 12/27/2022, 1/13/2023, 1/19/2023, 2/2/2023

 Revised: 6/1/2023 – added examples of possible management options by COIC (section 5.2) as per AAHRPP {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised:8/31/2023 - updated CHMC COI policy name from #ADM100 to ID 13201440. {Robert Lewis - IRB Assoc}

Section 1: General Human Research Protection Program Policies

1.26 PI Qualifications and Responsibilities

1.0 Purpose

The purpose of this policy and procedure is to describe the qualifications and responsibilities of the PI during the conduct of research within the Organization and at external sites under the PI’s protocol.


2.0 Policy

It is the policy of the Organization that the PI and all other personnel involved in the conduct of research must possess the required experience, skill, and appropriate medical licensure to safely conduct the research in full compliance with all applicable regulatory and Organizational requirements specified in HRPP policy 1.1 (Human Research Protection Program).


3.0 Definitions


4.0 Qualification Requirements for the PI


5.0 Responsibilities of the PI During the Conduct of Research


6.0 Responsibilities of the PI for the Conduct of PI-Initiated Multicenter Research


7.0 Additional Responsibilities of the PI during the Conduct of Research under the Oversight of an External IRB


8.0 Additional Responsibilities of the PI During Conduct of FDA Regulated Research

Note: FDA guidance regarding investigator responsibilities can be found in “Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects” (October 2009)


9.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IND


10.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IDE


DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

 Revised: 9/27/2017 - revision not documented

 Revised: 3/3/2018 - revision not documented

 Revised: 9/5/2018 - revision not documented

 Revised: 10/11/2019 - revision not documented

 Revised: 12/10/2019 - revision not documented

 Revised: 6/27/2022 - "Clarification of definition of "volunteer faculty; inclusion of emeritus faculty; inclusion of individuals operating under a special memorandum of understanding; clarification of requirement that volunteer conducting research with direct subject contact be present physically on campus, or have UNMC co-investigator physically on campus; faculty" {Approved: 6/27/2022 Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.27 Research Personnel Qualifications and Responsibilities

1.0 Purpose

The purpose of this policy and procedure is to describe the qualifications and responsibilities of personnel conducting research within the Organization and at external sites under the jurisdiction of the UNMC IRB.


2.0 Policy

It is the policy of the Organization that personnel involved in the conduct of research must possess the required experience, skill, education and (as appropriate) licensure to safely conduct the research in full compliance with all applicable regulatory and Organizational requirements specified in HRPP policy 1.1 (Human Research Protection Program).


3.0 General Requirements


4.0 Definitions of Research Personnel and Specific Requirements


DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded

 Revised: 2/18/2019 - revision not documented

Section 1: General Human Research Protection Program Policies

1.28 External Investigator Assurance

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for initiating an External Investigator Assurance (XIA) (also referred to as a “Collaborating Institutional Investigator Agreement”).


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Requirements for, and Content of, an External Investigator Agreement (XIA)


DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded (previous policy #3.14)

 Revised: 2/6/2018 - revision not documented

 Revision 12/3/2022 - Clarified that XIA is synonymous with “Collaborating Institutional Investigator Agreement”; revised definition of XI to include an investigator who is “not faculty, employee or student of the Organization, and who is not under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC”; clarified that an XIA is required for an XI conducting research at any site (including sites operated by the Organization), not just an external site; revised definitions for clarity; provided definition of “external site”; clarified that XIA is required between the Organization and the external site when an external site is engaged in research under a UNMC IRB approved research protocol for which there is not an IRB reliance agreement in place between UNMC and the site. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified - 12/29/2022

Section 1: General Human Research Protection Program Policies

1.29 ClinicalTrials.gov Reporting

1.0. Purpose

The purpose of this policy is to describe the requirements for registration and compliance with ClinicalTrials.gov.


2.0. Policy

It is the policy of the Organization that:


3.0. Definitions


4.0. Investigator Responsibilities

The following describes the responsibilities of the PI if he/she is the Responsible Party. If he/she is not the Responsible Party, then the PI is responsible only for assuring the IRB Application correctly reflects that the research study is registered with clinicaltrials.gov and that the NCT number is accurate. Otherwise, this section does not apply.


5.0. ORA responsibilities

The following describes the responsibilities of the ORA where faculty, student or employee of the Organization is the Responsible Party for a record on ClinicalTrials.gov; otherwise, the UNMC HRPP Policies do not apply.


DOCUMENT HISTORY:

 Written: 5/31/2018 (Approved: 5/31/2018) - original author not recorded

 Revised 1/6/2023 - Added requirement that CMS qualifying clinical trials must be registered and updated as required on ClinicalTrials.gov; specifically noted that BESH constitute clinical trials subject to this policy; added recommendation that clinical trials that meet the clinical trial definition of The International Committee of Medical Journal Editors (ICMJE) be registered and updated as required on ClinicalTrials.gov; clarified that if an investigator voluntarily registers a study on ClinicalTrials.gov even though registration is not required, all ClinicalTrials.gov requirements and UNMC HRPP policies related to ClinicalTrials.gov reporting apply; added that should the PI or the Record Owner leave the Organization, the PI is responsible for assuring that the Responsible Party and/or Record Owner are updated in the PRS database; revised ORA responsibilities and processes; added that investigator is responsible for submitting documentation from NIH specifying whether the trial constitutes a clinical trial; text reorganized and stylistic changes made for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/16/2023

 Revised 3/20/2023 - Provided regulatory reference for designation of “applicable clinical trials”; simplified “ORA Responsibilities” and deleted specific procedures; simplified “Investigator Responsibilities”; added that “If a study subject to this policy is completed ... the IRB protocol must remain open and active until the ClinicalTrials.gov record is resolved” (section 4.9); stylistic changes.{Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 1: General Human Research Protection Program Policies

1.30 Use of the Rapid Response IRB

1.0 Purpose

The purpose of this policy and procedure is to describe the criteria for use of, and the procedures for review by, the Rapid Response IRB (RR-IRB; IRB-03)


2.0 Policy


3.0 Constitution


4.0 Criteria for Use


5.0 Procedures


DOCUMENT HISTORY:

 Written: 2/5/2018 (Approved: 2/5/2018) - original author not recorded

Section 1: General Human Research Protection Program Policies

1.31 Observers at IRB Meetings

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for allowing observers at convened IRB meetings.


2.0 Policy


3.0 Justification for Attendance


4.0 Procedure


DOCUMENT HISTORY:

 Written: 2/26/2018 (Approved: 2/26/2018) - original author not recorded

Section 1: General Human Research Protection Program Policies

1.32 Confidentiality of the Review Process

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements and practices for assuring confidentiality of the process of review of human subjects research


2.0 Policy


3.0 Process


DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded

Section 1: General Human Research Protection Program Policies

1.33 Posting of Clinical Trial Consent Forms

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for posting of clinical trial consent forms, per requirements of 45 CFR 46.116(h).


2.0 Policy


3.0 Definitions


4.0 Investigator Responsibilities


5.0 ORA Procedures


DOCUMENT HISTORY:

 Written: 2/27/2019 (Approved: 2/27/2019) - original author not recorded

 Revised: 9/18/2019 - revision not documented

Section 1: General Human Research Protection Program Policies

1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs

1.0 Purpose

The purpose of this policy is to describe the Emergency Preparedness and Continuity of Operations Plan (EP/COOP) for the HRPP. This policy and accompanying documents focus on the Office of Regulatory Affairs (ORA) and the IRB; the Organization maintains plans for other components of the HRPP.


2.0 Policy

It is the policy of the Organization that:


3.0. General Comments


4.0. Specific Responsibilities in the Event of an Emergency


5.0. Specific Actions by the ORA and/or IRBs in the Event of an Emergency


6.0. EP/COOP Maintenance


7.0. Training and Education

The ORA will provide targeted communications and education/training regarding the UNMC HRPP EP/COOP to researchers and research staff, IRB Chairs and IRB members, study team members and PIs. As appropriate, the ORA, in collaboration with the UNMC and NM Office of Emergency Management will conduct periodic exercises to assure validity and operability of the plan.


Addendum

See UNMC HRPP EP/COOP plan


DOCUMENT HISTORY

 Written: 8/31/2023 (Approved: 9/1/2023) {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 2: Process of Review

Section 2: Process of Review

2.1 Submission for Items for Review by the IRB

1.0 Purpose

The purpose of this policy is to describe Organization’s requirements for submission and pre-review of all applications and research related forms and reports.


2.0 Policy

It is the policy of the Organization that all submissions will be processed efficiently by the Office of Regulatory Affairs (ORA) for review in accordance with applicable HRPP policies.


3.0 Submission Requirements


4.0 Deadlines for Submission


5.0 IRB Review Limits


6.0 Determination of Required IRB Review


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 2/5/2018 - revision not documented

 Revised: 7/19/2022 - Deleted list of types of forms for review; clarified which items allowable for submission in paper format; corrected deadlines for submission; clarified maximum number of protocols to be reviewed {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/16/2022

Section 2: Process of Review

2.2 Full IRB Review

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for: 1) submission of items required for full IRB review; 2) organization, scheduling, and conduct of full IRB meetings; 3) IRB approval criteria; 4) IRB actions; and 5) IRB documentation of actions.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Procedures


5.0 Deadlines for PI Responses


6.0 Review of PI Responses


7.0 IRB Approval Periods


8.0 Final IRB Approval Letter


9.0 Review by Other Organizational Committees


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 3/29/2018 - revision not documented

 Revised: 6/2/2021 - Added IRB-05; added definitions (section 3.0); simplified overall by referencing other policies where appropriate; revised procedures to reflect activities during teleconference meetings; clarified when meeting materials will be available (especially for RR-IRB and special review items); revised to delete references to paper copy distribution of materials (all materials available thru RSS); clarified assignment of reviewers; added that chair may vote to break a tie vote; clarified types of other IRB determinations (section 4.9); deleted list of types of items for which documentation of quorum required (section 4.12); revised deadlines for PI responses to be consistent with Policy 2.3. (Expedited Review); clarified that IRB administrator authorized to communicate with investigator to resolve inadequate or incomplete responses to request for minor modifications or clarifications; revised description of contents of condition approval and final approval letters; deleted references to pre-2018 Common Rule and corrected regulatory citations.

 Revised: 10/13/2022 - Modified definition of “controverted issues”; revised throughout to reflect meetings by video conference; clarified identification of members recused; deleted list of materials supplied to members and clarified that materials available in RSS; deleted 20 minute discussion time limit; clarified that IRB approval is distinct from ORA release; deleted IRB action “decline to review”; clarified criteria for disapproval; combined descriptions of contents of core minutes and addended letters; revised policy to require documentation of findings and determinations in the final ORA approval letter as opposed to the initial IRB review letter. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 10/13/2022 - amended section numbers due to removal of 4.10.5, amended 8.1.1 to align with heading 8.2, amended 8.2 sequentially to 8.3 (Robert Lewis - IRB Assoc)

 Board Notified: 11/22/2022

 Revised: 11/30/2022 - corrected language in 4.3.3 from: “IRB meetings may be conducted in person, or via video conferencing, as appropriate. In either case If meetings are conducted by video conference, Members will have access to all relevant materials prior to the meeting and will be able to participate actively and equally in all discussions.”, to: “IRB meetings may be conducted in person, or via video conferencing, as appropriate. Members will have access to all relevant materials prior to the meeting and will be able to participate actively and equally in all discussions.” (Robert Lewis - IRB Assoc)

 Revised: 7/31/2023 – revised sections 4.4.5 and 4.6.1.1 to more fully describe the assessment of the need for an expert consultant; added description of items to be reviewed (section 4.6.2); revised 4.10.3.2 to state explicitly that tabled protocols will be returned to the convened IRB for further review. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 2: Process of Review

2.3 Expedited Review

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for using expedited review procedures for consideration of: 1) new research proposals; 2) continuing review of previously approved research; 3) minor changes in protocol; 4) minor complaints; and 5) non-serious noncompliance.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Expedited Review Categories


5.0 Procedures


6.0 Expedited Review Actions


7.0 Development of IRB Expedited Review and Final Approval Letters


8.0 Deadlines for PI Responses


9.0 Review of PI Responses


10.0 Final IRB Approval Letter


11.0 IRB Approval Periods


12.0 Documentation of Expedited Review


13.0 Review by Other Organizational Committees


DOCUMENT HISTORY:

 Written: 4/11/2016 (Approved: 4/11/2016) - original author not recorded

 Revised: 6/13/2018 - revision not documented

 Revised: 3/17/2021 - Clarified that IRB administrator may re-review “inadequate or incomplete responses” by investigators (or refer back to the expedited reviewer for re-review) and further communicate with the investigator to seek modifications or clarifications; deleted regulatory references to pre-2018 Common Rule; deleted list of “other determinations (section 5.4) and referenced policy 2.2 instead; deleted list of other organizational committees (section 13.1) and referenced policy 1.10 instead.

 Revised: 9/16/2021 - Revised time allowed for investigator to respond (section 8.1) to match policy 2.2

 Revised: 8/4/2023 – generally revised for clarity and for consistency with HRPP 2.2; deleted reference to limited IRB review (section 2.4) since the Organization does not utilize limited IRB review, as per policy HRPP 2.8; revised section 5.3 to better describe Expedited Review Procedures; revised section 5.4 to more fully describe Criteria for Expedited IRB Approval and Other Determinations and to clarify requirement for expedited reviewer to determine and document if research needs continuing review; added description of items to be reviewed (section 5.3.2); simplified section 8.0 (Deadlines for PI Responses; clarified that expedited reviewer may refer a protocol to the convened IRB if they believe it would be more appropriately reviewed by the convened IRB (section 6.4.1); corrected typographic and grammatical errors. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 2: Process of Review

2.4 IRB Review of Changes in Previously Approved Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review of changes in previously approved research, including single subject protocol deviations.


2.0 Policy


3.0 Definitions


4.0 Procedures for Change Request in Protocol (other than Single Subject Protocol Deviation)


5.0 Procedure for Single Subject Protocol Deviation*


6.0 Changes in a research activity requiring immediate implementation


7.0 Provision of new information to subjects which requires immediate implementation


Appendix to HRPP Policy 2.4 (Changes in Previously Approved Research)

Examples of Major and Minor Changes in Protocol or Single Subject Protocol Deviations (per Sections 3.1 and 3.2)

Examples of Major Changes:

 Changes in inclusion or exclusion criteria that broaden eligibility (i.e., broadening the range of the inclusion criteria or narrowing the range of the exclusion criteria) when risks to new subjects will be different than to previously eligible subjects

 Addition of a vulnerable population (e.g., children, cognitively impaired, prisoners, socially or educationally disadvantaged, students)

 Increase in target accrual of subjects in studies where UNMC. CHMC and/or UNO are the only sites

 Increase in study wide accrual of subjects in a multi-institution study

 Increase in subject payment amount that exceeds criteria in HRPP Policy

 Change in study design, where such change might affect risk, potential benefit to subject or scientific value or validity

 Alterations in the dosage or route of administration of an administered drug

 Addition of research activities that carry greater than minimal risk

 Change in research activities where the change might negatively impact the potential benefit of the research (e.g., change from one questionnaire to another which is not substantively similar, or to a non-validated questionnaire; change from CT-based staging to clinically based staging of a tumor)

 Modification of research questionnaires or data collection instruments/processes to collect sensitive information (e.g., depression, sexuality, illegal activities)

 Addition of an element that may affect subject confidentiality (e.g., specimen banking or genetic testing; addition of focus groups or identifiable surveys)

 Extending substantially the duration of exposure to the test material or intervention

 Deletion of laboratory tests, monitoring procedures, or study visits directed at the collection of information for safety evaluations

 Addition of serious adverse events, serious UADEs or other significant risks to the Informed Consent process or form

 Addition of a new (additional) consent form

 Addition of a qualified investigator with a disclosable conflict of interest

 Changes, which, in the opinion of the IRB chairperson or his/her designee, do not meet the criteria or intent of a minor modification

Note: Multiple minor changes in the protocol, instruments, and/or consent may, together, be considered a major change subject to convened IRB review

Examples of Minor Changes:

 Changes in inclusion or exclusion criteria that narrow eligibility (i.e., narrowing the range of the inclusion criteria or broadening the range of the exclusion criteria).

Note: such changes should not appreciably reduce the likelihood that the research can be completed in a timely manner

 Changes in inclusion or exclusion criteria that broaden eligibility (i.e., broadening the range of the inclusion criteria or narrowing the range of the exclusion criteria) when the investigator provides evidence that risks to the new subjects will not be different than to previously eligible subjects

 Increase in local enrollment of subjects in a multi-institution study without a change in the overall study wide enrollment target

 Addition of research activities that constitute no more than minimal risk.

Note: addition of clinically indicated procedures where data will be used for research purposes (i.e., where the incremental risk is no more than minimal) are considered a minor change

 Addition of research activities that would be eligible for expedited IRB review (per §_.110(b)(ii)) under categories 1-7 (unless specifically defined as “major” above)

 Alterations in the dosage form (e.g., tablet to capsule or oral liquid) of an administered drug, provided the dose and route of administration are unchanged

 Decrease in the number or volume of biological samples collection, provided that such a change does not affect the collection of information related to safety evaluations;

 Decrease in the length of hospitalization or number of study visits, provided such a decrease does not affect the collection of information related to safety evaluations

 Alternations subject payment schedule, provided such payments remain fairly pro-rated

 Increase in subject payment amount provided such amounts are within criteria in HRPP Policy

 Changes to improve the clarity of statements or to correct typographical errors in the protocol, CF or any questionnaire, provided that such a change does not alter the content or intent of the statement

 Changes in recruitment materials and advertising, provided such items continue to satisfy criteria in HRPP Policy

 Revision of subject identification and recruitment strategy to include use of the Nebraska Medicine Conditions of Treatment Opt-In database.

 Addition or deletion of qualified investigators or personnel

 Addition of study sites (that have a valid FWA and Reliance agreement as appropriate); or that serve as performance sites where informed consent will not be obtained; or that serve as performance sites where informed consent will be obtained by a UNMC, CHMC or UNO investigator.


DOCUMENT HISTORY:

 Written: 1/5/2016 (Approved: 1/5/2016) - original author not recorded

 Revised: 1/24/2018 - revision not documented

 Revised: 10/4/2018 - revision not documented

Section 2: Process of Review

2.5 Criteria for IRB Approval

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s criteria for IRB approval for human subject research, reviewed both by the full convened IRB or thorough an expedited review process.


2.0 Policy

It is the policy of the Organization human subject research must satisfy certain basic ethical and regulatory requirements, including those described in 45 CFR 46.111 and 21 CFR 56.111.


3.0 Criteria for IRB Approval

Each of the following criteria for IRB approval must be satisfied in full accordance with applicable federal regulations and HRPP policies which contain greater detail about how the IRB interprets and applies these criteria. The criteria must be met before the IRB can grant approval of any submission by expedited review or full IRB review.


4.0 Additional Considerations

In addition to the specific criteria described in section 3.0, the IRB will consider other applicable federal, state and local law and regulations, Organization policies, and basic ethical principles (as described in the Belmont Report, or the World Medical Association Declaration of Helsinki) when deciding whether a research proposal is approvable.


DOCUMENT HISTORY:

 Written: 1/11/2016 (Approved: 1/11/2016) - original author not recorded

 Revised: 1/24/2018 - revision not documented

Section 2: Process of Review

2.6 Exempt Research

2.6 Exempt Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for determining if a research proposal is eligible for exemption under 45 CFR 46.104(d) and 21 CFR 56.104, with appropriate protections in place for research subjects.

2.0 Policy
It is the policy of the Organization that:

3.0 Categories of Exemption

4.0 Limitations on Categories of Exemption

5.0 Procedures

Note: The Organization does not utilize Exemption categories 7 and 8.

Note: If the Exempt Application was used, the PI will be instructed to fill out the Biomedical Research OR Behavioral and Social Science Research in order to provide the IRB with the information needed to perform a thorough review to ensure that the IRB approval criteria at 45 CFR 46.111 have been satisfied.

6.0 Criteria for Approval of Exempt Research

7.0 Actions

8.0 Review by Other Organizational Committees


DOCUMENT HISTORY:

 Written: 1/5/2016 (Approved: 1/5/2016) - original author not recorded

 Revised: 2/5/2018 - revision not documented

 Revised: 8/11/2020 - Clarified eligibility of children for exemption category 2, clarified requirement for documentation of informed consent for exempt research

 Revised: 10/7/2020 - Deleted exempt categories from pre-2019 Rule (section 3.1); other minor clarifications and corrections

 Revised: 2/28/2022 - Corrected typographic errors; deleted references to pre-2019 Rule; other stylistic changes

Section 2: Process of Review

2.7 Continuing Review of Research

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for continuing review of approved research


2.0 Policy

It is the policy of the Organization that:


3.0 Continuing Review Frequency


4.0 Criteria for Review


5.0 Investigator Responsibilities


6.0 ORA/IRB Responsibilities


DOCUMENT HISTORY:

 Written: 2/6/2018 (Approved: 2/6/2018) - original author not recorded

 Revised: 9/7/2018 - revision not documented

 Revised: 1/29/2021 - Clarified “procedures that subjects would undergo as part of clinical care” per (45 CFR 46.109(f)(iii)(B)) (section 3.2.3); clarified which IRBs can perform continuing review (sections 5.2 thru 5.5); various minor clarifications and corrections

 Revised: 1/30/2023 – Revised to stress distinction between FDA regulated and non-regulated research; clarified process for submission of demographic information for research that is exempt, or for which continuing review is no longer required (section 6.1.4); deleted requirement that convened IRB be notified of Request to Continue Treatment for Enrolled Subjects on Approval Expired Studies; changed “20 working days” to “30 calendar days”; reformatted; various minor clarifications and corrections. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/31/2023

 Revised: 5/17/2023 - Corrected 6.14 to reflect accurate form name, corrected typo of 30 days to 20 days in 6.14.1 (Robert Lewis, IRB Assoc)

Section 2: Process of Review

2.8 Limited IRB Review

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements and procedure for limited IRB review.


2.0 Policy

It is the policy of the Organization that the Organization does not utilize limited review as described in 45 CFR 46.104(d)(2, 3, 7 or 8).


DOCUMENT HISTORY:

 Written: 1/24/2018 - (Approved: 1/24/2018) - original author not recorded

 Revised: 6/5/2023 – deleted text; inserted statement that the Organization does not conduct limited review.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 2: Process of Review

2.9 Closure of On-Going Research

1.0 Purpose

The purpose of this policy is to describe the criteria for, and process of, closing an on-going human research study, and to describe the Organization’s requirements of investigators when studies are closed.


2.0 Policy

It is the policy of the Organization that


3.0. Definitions


4.0. Closure for Inadequate Accrual


5.0. Closure of Studies in Standard Follow-Up


6.0 Closure Procedures


DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded

 Revised: 1/29/2021 - Added inadequate accrual as reason for closure by IRB (section 3.1.4) and criteria and process for closure (section 4); added prolonged time in standard follow-up as reason for closure by ORA (section 3.1.5) and criteria and process for closure (section 5).

 Revised: 08/10/2023 – clarified that “closure” includes cessation of analysis of identifiable data; deleted definitions of suspension and termination as irrelevant to this policy; clarified possible options for improving accrual; clarified that closure for inadequate accrual, or of studies in prolonged follow-up may (not “must”) occur; clarified investigator responsibilities regarding study closure by the investigator; added that studies closed for failure to respond to “approval expired” notification may not be reactivated, but will require submission of a new application. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

Section 3: Special Issues

Section 3: Special Issues

3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for determining the need for: 1) IRB review more often than annually, 2) increased monitoring, and 3) verification from sources other than the PI that no material changes have occurred since previous IRB review.


2.0 Policy

It is the policy of the Organization that that all non-exempt research will be assessed at both initial and continuing review in accordance with the requirements set forth by HHS regulations at 45 CFR 46.103(b)(4), FDA regulations at 21 CFR 56.108(a)(2), and all applicable state and local laws.


3.0 Increased Monitoring and/or Interim Continuing Review


4.0 Verification from Sources Other than the Investigator


DOCUMENT HISTORY:

 Written: 1/8/2016 (Approved: 1/8/2016) - original author not recorded

 Revised: 1/2/2018 - revision not documented

Section 3: Special Issues

3.2 Data and Safety Monitoring

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for data and safety monitoring for non-exempt research.


2.0 Policy

It is the policy of the Organization that all non-exempt research must have an appropriate plan for data and safety monitoring in consideration of the nature and risk level of the research. The Data and Safety Monitoring Plan (DSMP) may or may not include a formal Data and Safety Monitoring Board (DSMB).


3.0 Data and Safety Monitoring Plan (DSMP)


4.0 Data Safety Monitoring Board (DSMB)


5.0 Review of the DSMP by the IRB


6.0 Review of DSMB Reports by the IRB


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised 12/22/2022 – Clarified expected contents of DSMP; other revisions to eliminate duplicate text and for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified - 12/29/2022

Section 3: Special Issues

3.3 Privacy Interests and Confidentiality of Research Data

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for 1) protection of privacy interests of research subjects, and 2) maintenance of confidentiality of data. For the purposes of this policy “subjects” and “participants” are synonymous, and includes those persons participating in a data registry or biobank.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Protection of Privacy


5.0. Protection of Confidentiality


DOCUMENT HISTORY:

 Written: 1/28/2016 (Approved: 1/28/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised – 9/22/2022 - Stylistic changes, and changes for clarity; clarified privacy requirements regarding informed consent process; clarified applicability of CoC and consent form language during interruption in or termination of NIH funding; added acknowledgement of CoCs issued by agencies other than NIH. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/29/2022

Section 3: Special Issues

3.4 Use of Protected Health Information in Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for ensuring the appropriate protections for use of Protected Health Information (PHI) in research.


2.0 Policy


3.0 Definitions


4.0 Use or Disclosure of PHI for Research

The Privacy Rule permits the Organization to use or disclose PHI for research only under certain circumstances and conditions as described below:


5.0 Procedures


DOCUMENT HISTORY:

 Written: 1/28/2016 (Approved: 1/28/2016) - original author not recorded

 Revised: 4/9/2018 - revision not documented

Section 3: Special Issues

3.5 Subject Recruitment Through Advertisements

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for recruitment of subjects through advertisements. For the purpose of this policy, “advertisements” refer to printed advertisements (including bulletins, newsletters, posters, fliers, and magazine or newspaper ads); radio and television advertisements; and electronic advertisements (including social media or other on-line venue).

Note: Invitations to participate directed to specific persons are covered by HRPP policy 3.6 (Subject Recruitment Through Direct Invitation).


2.0 Policy

It is the policy of the Organization that


3.0 General Requirements and Prohibitions


4.0 Printed Advertisement


5.0 Radio and Television Advertisements


6.0 Electronic Advertisements (including social media or other on-line venue)


7.0 Submission and Review of Advertisements


DOCUMENT HISTORY:  Written: 4/14/2016 (Approved: 4/14/2016) - original author not recorded

 Revised: 6/28/2018 - revision not documented

 Revised 9/9/2022 – Clarified that advertisements related to research for which the Organization is relying on another IRB as the IRB of record, must be adhere to this policy; however, the ORA will not routinely review such advertising unless requested to do so by the investigator or the reviewing IRB. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 9/15/2022 – removed requirement that printed advertisements be prepared within RSS (functionality not yet implemented). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 10/12/2022 - emphasized what information “must” be included vs “may” be included, in advertisements {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/29/2022

 Revised: 12/1/2022 - typo corrected in 7.0 (Robert Lewis - IRB Assoc)

 Revised: 3/29/2023 - typos corrected in Section 2.0 and section numbering corrected 2.1-2.4 (Robert Lewis - IRB Assoc)

Section 3: Special Issues

3.6 Subject Recruitment Through Direct Invitation

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for subject recruitment through direct invitations to participate.
Subject recruitment through advertisements is described in HRPP policy 3.5.


2.0 Policy


3.0 Definitions


4.0 Invitations to Patients


5.0 Invitations to Prospective Subjects who are not Patients

This section applies to prospective subjects who may be eligible for participation in research but who are not primarily eligible because they have a disease or condition being diagnosed or treated at UNMC/Nebraska Medicine (including hospital and/or clinics), Bellevue Medical Center, or Children’s Hospital & Medical Center (including Children’s Physicians Clinics). They may be patients or former patients, but that is not the primary reason they may be eligible.

Note: Examples of this subject population would be public or private school students; college, trade or professional school students (e.g., UNO freshman, enrollees at a particular trade school, UNMC SOM students); cultural, ethnic or religious groups (e.g., Sudanese immigrants, members of a particular church); trades or professions (e.g., farmers, physicians, prison guards).


DOCUMENT HISTORY:

 Written: 8/23/2018 (Approved: 8/23/2018) - original author not recorded

Section 3: Special Issues

3.7 Finder’s Fees and Recruitment Bonuses

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements related to finder’s fees and recruitment bonuses.


2.0 Policy

HHS regulations at 45 CFR 46.116 and FDA regulations at 21 CFR 56.116 require minimization of the possibility of coercion or undue influence. It is the view of the Organization that payment of finder’s fees or recruitment bonuses to investigators or to any representative of the Organization may create the perception that subjects or potential subjects could be unduly influenced or coerced to participate (or continue participation). Therefore, it is the policy of the Organization that such payments are not permitted.


3.0 Definitions


4.0 Finder’s Fees


5.0 Recruitment Bonuses


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 1/26/2018 - revision not documented

Section 3: Special Issues

3.8 Research Subject Compensation and Reimbursement

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements and limitations regarding compensation and reimbursement of research subjects.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 General Principles


5.0 Specific Requirements for Compensation


6.0 Requirements for Reimbursement


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 5/10/2017 - revision not documented

 Revised: 1/26/2018 - revision not documented

 Revised: 3/8/2019 - revision not documented

 Revised: 8/31/2021 - Separated policies and requirements for compensation (payment) from reimbursement, and reorganized policy accordingly; included definitions of above; explicitly stated that investigators should attempt to minimize financial sacrifice on the part of subjects and, as possible and appropriate, offer equitable reimbursement for costs; explicitly stated that compensation for minimal risk research may represent a reasonable incentive for participation (previously implied since no restriction placed on payment for minimal risk research); added prohibition that reimbursement for travel associated expenses may not be contingent on distance; specified preferred mechanism for compensation and reimbursement; allowed for direct payment to adolescents (and older children with justification).

 Revised: 6/5/2023 - Revised section 5.2 to allow the IRB has the authority to review the level of compensation and, in appropriate circumstances, limit or increase the total value; revised section 5.7 to delete preferred method of payment (preferred method will be decided by B&F; revised section 5.7 to allow, within acceptable payment mechanisms, the IRB or expedited reviewer may require a particular method in order to minimize risks or provide equitable compensation.

 Revised: 8/12/2023 - Clarified that section 6.4 refers to an “arbitrary distance threshold”; minor grammatical changes.

Section 3: Special Issues

3.9 Contraception Requirements

1.0 Purpose

The purpose of this policy and procedure is to describe the contraception requirements for subjects participating in research.


2.0 Policy

It is the policy of the Organization that subjects must utilize appropriate contraception methods while participating in research with potential for reproductive toxicity.


3.0 Categories based on FDA Pregnancy and Lactation Labeling Rule (PLLR)


4.0 Definitions of the FDA Use-In-Pregnancy Categories


5.0 Procedure


ADDENDUM #1

ICF Pregnancy Risk Statements

Category A or Group 1 drugs:

PREGNANCY RISKS It is possible that the medicines used in this study could injure a fetus [OR an unborn child] if you, or your partner, become pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions

Category B or Group 2 or Group 3 drugs when contraception is NOT required:

PREGNANCY RISKS It is possible that the medicines used in this study could injure a fetus [OR an unborn child] if you, or your partner, become pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions.

Category B or Group 2 or Group 3 drugs when contraception IS required:

PREGNANCY RISKS It is possible that the medicines used in this study could injure a fetus [OR an unborn child] if you, or your partner, become pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions.

You may want to discuss this with others before you agree to take part in this study. If you wish, we will arrange for a doctor, nurse, or counselor who is not part of this study to discuss the potential risks and benefits with you and anyone else you want to have present.

Because of the potential risks, you, or your partner, must not become pregnant while you are participating in this study. Women must have a negative pregnancy test before entering the study [and before each treatment – as appropriate].

If you are sexually active and can get pregnant, or can get your partner pregnant, you must use ONE appropriate method of birth control every time you have sex, or you must not have sex.

You can get additional information about methods to avoid pregnancy by calling the UNMC Research Subject Advocate’s Office at (402) 559-6941.

You will need to continue to use birth control to avoid pregnancy for X months after finishing the research.

By signing this and being in the study, you are agreeing to not get pregnant while you are on the study and for X months after. Should you become pregnant while on this study, you should immediately notify the study personnel. The investigator will assist you in finding appropriate medical care. The investigator also may ask to be allowed to continue getting information about your pregnancy. You can refuse to provide this information.

Category C or Group 4 drugs:

PREGNANCY RISKS It is possible that the medicines used in this study could injure a fetus [OR an unborn child] if you, or your partner, become pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions.

You may want to discuss this with others before you agree to take part in this study. If you wish, we will arrange for a doctor, nurse, or counselor who is not part of this study to discuss the potential risks and benefits with you and anyone else you want to have present.

Because of the potential risks, you, or your partner, must not become pregnant while you are participating in this study. Women must have a negative pregnancy test before entering the study [and before each treatment – as appropriate].

If you are sexually active and can get pregnant, or can get your partner pregnant, you must use ONE [or TWO] appropriate method(s) of birth control every time you have sex, or you must not have sex.

Because of the possible risk to the fetus [OR an unborn child], methods of natural family planning are not, by themselves, reliable enough to avoid pregnancy.

You can get additional information about methods to avoid pregnancy by calling the UNMC Research Subject Advocate’s Office at (402) 559-6941.

You will need to continue to use birth control to avoid pregnancy for X months after finishing the research.

By signing this and being in the study, you are agreeing to not get pregnant while you are on the study and for X months after. Should you become pregnant while on this study, you should immediately notify the study personnel. The investigator will assist you in finding appropriate medical care. The investigator also may ask to be allowed to continue getting information about your pregnancy. You can refuse to provide this information.

Category D or Group 5 Drugs:

PREGNANCY RISKS It is possible that the medicines used in this study could injure a fetus [OR an unborn child] if you, or your partner, become pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions.

You may want to discuss this with others before you agree to take part in this study. If you wish, we will arrange for a doctor, nurse, or counselor who is not part of this study to discuss the potential risks and benefits with you and anyone else you want to have present.

Because of the potential risks, you, or your partner, must not become pregnant while you are participating in this study. Women must have a negative pregnancy test before entering the study [and before each treatment – as appropriate].

If you are sexually active and can get pregnant, or can get your partner pregnant, you must use TWO appropriate methods of birth control every time you have sex, or you must not have sex.

Because of the possible risks to a fetus [OR an unborn child], methods of natural family planning are not, by themselves, sufficiently reliable to avoid pregnancy.

You can get additional information about methods to avoid pregnancy by calling the UNMC Research Subject Advocate’s Office at (402) 559-6941.

You will need to continue to use birth control to avoid pregnancy for X months after finishing the research.

By signing this and being in the study, you are agreeing to not get pregnant while you are on the study and for X months after. Should you become pregnant while on this study, you should immediately notify the study personnel. The investigator will assist you in finding appropriate medical care. The investigator also may ask to be allowed to continue getting information about your pregnancy. You can refuse to provide this information.

Category X Drugs:

Since studies of the drug in humans, or investigational or post-marketing data, have demonstrated fetal risk, contraception is required and the language must be at least as protective as Category D language above. If the sponsor or FDA require inclusion of specific language relating to fetal risk, monitoring for pregnancy and prevention of pregnancy in the ICF, it may be included, and redundant category D language deleted.


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 11/21/2017 - revision not documented

Section 3: Special Issues

3.10 Pregnancy Testing

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for determining how and when pregnancy testing should be performed on subjects who are of childbearing potential enrolled in protocols that describe pregnancy as an exclusion criterion.


2.0 Policy

It is the policy of the Organization that when women of childbearing potential are enrolled in protocols which include a pregnancy exclusion criterion, the protocol must have procedures in place for either pregnancy testing or self-reporting depending on the teratogenic risk.


3.0 Definition


4.0 Procedures


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 1/8/2018 - revision not documented

Section 3: Special Issues

3.11 Collecting Data from Pregnant Partners of Research Subjects

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for obtaining informed consent, and collecting data from pregnant partners of research subjects and from their infants.


2.0 Policy


3.0 General Considerations


4.0 IRB Review



DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded

 Revised: 9/9/2019 - revision not documented

Section 3: Special Issues

3.12 Ethical Access

1.0 Purpose

The purpose of this policy is to define ethical access and to describe the Organization’s requirements to protect the privacy of patients in the context of recruitment for participation in research, or for identification of subjects for review of medical records.


2.0 Policy

It is the policy of the Organization that obtainment of information about a potential subject, and approach to the potential subject, must occur in a manner that respects the privacy of that person.


3.0 Ethical Access for Recruitment of Subjects

For the purposes of this policy, the recruitment of subjects requires two distinct activities, each of which must respect the privacy of patients: (1) obtainment of information about the patient which leads the investigator to believe or conclude that the patient is eligible for the research, and (2) subsequent approach to the patient to explain the research and obtain his/her consent to participate.


4.0 Ethical Access for Review of Medical Records


5.0 IRB Procedure


DOCUMENT HISTORY:

 Written: 4/16/2018 (Approved: 4/16/2018) - original author not recorded

 Revised: 11/20/2018 - revision not documented

 Revised: 2/18/2019 - revision not documented

Section 3: Special Issues

3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of clinical trials that utilize placebos or wash-out of effective therapy.


2.0 Policy


3.0 Definition


4.0 Ethical Justification


5.0 Study Design Considerations



DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not recorded

 Revised: 2/7/2018 - revisions not documented

Section 3: Special Issues

3.14 Phase I and First-in-Human Studies

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of Phase I and First in Human Studies.


2.0 Policy


3.0 Definitions


4.0 General Principles


5.0 IRB Review



7.0 Phase I Studies in Children


8.0 Phase I Studies in Decisionally Impaired Persons


DOCUMENT HISTORY:

 Written: 2/5/2018 (Approved: 2/5/2018) - original author not recorded

Section 3: Special Issues

3.15 Managing Radiographic Incidental Findings in Human Subjects Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for disclosure, or nondisclosure, of radiographic incidental findings that may affect the management of a subject’s current or future health or welfare.


2.0 Policy


3.0 Definitions


4.0 Procedures


5.0 Model CF Language


6.0 IRB Review


DOCUMENT HISTORY:

 Written: 2/28/2018 (Approved: 2/28/2018) - original author not recorded

Section 4: Vulnerable Populations

Section 4: Vulnerable Populations

4.1 Additional Protections for Vulnerable Populations

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for additional protections for vulnerable populations.


2.0 Policy


3.0 Definition


4.0 Categories of Vulnerability


5.0 Additional Protections for Vulnerable Populations


6.0 Investigator and IRB Procedures Regarding Inclusion of Vulnerable Persons or Populations


DOCUMENT HISTORY:

 Written: 1/6/2016 (Approved: 1/6/2016) - original author not recorded

 Revised: 1/26/2018 - revision not documented

Section 4: Vulnerable Populations

4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for IRB review and approval of research involving pregnant women, fetuses, and neonates (nonviable or of uncertain viability).


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 IRB Review

In addition to review of research under HHS regulations at 45 CFR 46 (Subpart A) and FDA regulations at 21 CFR 50, 56 as applicable, the IRB must assure additional protections are in place for pregnant women, fetuses and/or neonates involved in research in accordance with the following:


5.0. Non-pregnant subjects who become pregnant during research


6.0 Documentation of Compliance with Subpart B


DOCUMENT HISTORY:

 Written: 1/6/2016 (Approved: 1/6/2016) - original author not recorded

 Revised: 2/20/2018 - revision not documented

 Revised: 12/22/2022 – clarified exceptions to requirements under subpart B for research not subject to subpart B (section 4.1.2); deleted specific language related to 45 CFR 46.207 (section 4.5); stylistic changes for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/12/2023

Section 4: Vulnerable Populations

4.3 Research Involving Prisoners

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for review and approval of research involving prisoners.


2.0 Policy


3.0 Definitions


4.0 Additional IRB Requirements


5.0 Permitted Research Involving Prisoners


6.0 Procedures for IRB Review of Research Involving Prisoners*


7.0 IRB Findings


8.0 Documentation of Compliance with Subpart C


9.0 Special Circumstances


DOCUMENT HISTORY:

 Written: 4/14/2016 (Approved: 4/14/2016) - original author not recorded

 Revised: 2/19/2018 - revision not documented

 Revised: 12/10/2019 - revision not documented

Section 4: Vulnerable Populations

4.4 Research Involving Children

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for research involving children.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Categories of Research

HHS and FDA regulations specify that research involving children must be approvable under one or more of the following four categories and meet the specified criteria. For the purposes of this policy, “IRB” refers both to the convened IRB and to an expedited reviewer as described in HRPP 2.3 (Expedited Review).


5.0 Requirements for Parental Permission


6.0 Requirements for Child Assent


7.0 Procedures for Child Assent



9.0 Assent of Subjects Reaching the Age of 13 Years (Age of Written Assent)


10.0 Procedures for IRB Review


11.0 Documentation of Compliance with Subpart D


DOCUMENT HISTORY:

 Written: 1/6/2018 - original author not recorded

 Revised: 2/19/2018 - revision not documented

 Revised 11/8/2022 - Deleted reference to Parental ICF; clarified that waiver of parental permission allowed under 2017 FDA guidance; added definition of ward per Nebraska Administrative Code; deleted pre 2018 Common rule citations; specified requirements to apply subpart D to non-exempt research only; clarified that “IRB” refers to convened IRB and to expedited reviewer; deleted reference to Youth Information sheet; clarified that Youth signs the appropriate signature blank on the ICF; clarified age 13 as “age of written assent” (rather than “age of assent”) {section 9.0}; clarified process of written assent upon reaching age 13. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/30/2022

Section 4: Vulnerable Populations

4.5 Local 407 Panel Review of Pediatric Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for convening a local 407 Panel to consider pediatric research which is not federally funded or FDA regulated.


2.0 Policy

It is the policy of the Organization that research involving minors which is neither funded by HHS nor regulated by FDA, and which presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children but does not meet the requirements of HHS regulations at 45 CFR 46.404, 46.405, or 46.406 may be reviewed by a local 407 panel.


3.0 Definitions


4.0 Eligibility for Local 407 Panel Review


5.0 Local 407 Panel Membership


6.0 407 Panel Review


7.0 Full IRB Review


DOCUMENT HISTORY:

 Written: 1/28/2016 (Approved: 1/28/2016) - original author not recorded

 Revised: 2/19/2018 - revision not documented

Section 4: Vulnerable Populations

4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for IRB review of research involving subjects who have impaired decision-making capacity.


2.0 Policy

It is the policy of the Organization that research involving subjects who have impaired decision-making capacity must include appropriate additional protections in accordance with the ethical principles described in the Belmont Report, and the requirements of 45 CFR 46.111(b) and 21 CFR 56.111(b), as applicable.


3.0 Definitions


4.0 Assessment of Capacity to Consent


5.0 Appointment and Authority of the LAR


6.0 Assent and Dissent


7.0 Acceptable Research Involving Decisionally Impaired Subjects


8.0 Additional Protections

In consideration of the characteristics of the subject population, the nature of the research and the risk level, the IRB will determine what additional protections are necessary. Additional protections for vulnerable subject populations which include individuals who are decisionally impaired are described in HRPP policy 4.1 (Additional Protections for Vulnerable Populations).


9.0 IRB Review


10.0 Disclosure and Consent for Continuing Participation

If a person with diminished capacity regains capacity during the conduct of the research, he/she must be fully informed about the research and the circumstances of his/her enrollment. His/her consent to continue in the research protocol must be obtained in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).


11.0 Disclosure After the Research has Been Completed

If a person with diminished capacity regains capacity following completion of the conduct of the research, he/she must be fully informed about the research and the circumstances of his/her enrollment.



DOCUMENT HISTORY:

 Written: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

 Revised: 1/29/2018 - revision not documented

 Revised: 12/8/2022 - Revised definition of LAR as per 45 CFR 46.102(i); deleted reference to pre-2018 Common Rule; defined IAS and clarified priority order of IAS by referencing Nebraska Medicine policy MS14; defined dissent; deleted reference to LAR ICF {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/12/2023

Section 4: Vulnerable Populations

4.7 Research Involving Employees of the Organization and Students as Subjects

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of research involving employees of the Organization, and/or students as subjects. These persons are considered vulnerable because of the potential for undue influence or coercion.


2.0 Policy


3.0 Students as Research Participants


4.0 Research Involving Employees of the Organization as Research Participants


5.0 IRB Review


DOCUMENT HISTORY:

 Written: 1/7/2016 (Approved: 1/7/2016) - original author not recorded

 Revised: 1/29/2018 - revision not documented

Section 5: Informed Consent

Section 5: Informed Consent

5.1 Obtaining Informed Consent From Research Subjects

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the process and documentation of informed consent.


2.0 Policy

It is the policy of the Organization that:


3.0 General Requirements


4.0 Elements of Informed Consent