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: 1) ensure the rights and welfare of human subjects are protected, 2) evaluate and continually improve the protection of human research subjects, and 3) 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 four IRBs, other review committees, administrative offices, and administrative officials as described in this policy.


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY HISTORY:

 INITIAL - APRIL 4, 2016

 AMENDED - MARCH 27, 2018

 AMENDED – SEPTEMBER 4, 2018

 AMENDED – MAY 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.

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:


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY HISTORY:

Revised May 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.

 INITIAL - APRIL 4, 2016

 AMENDED - MARCH 9, 2018

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


ADMINISTRATIVE APPROVAL:

POLICY AMENDED:

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


ADMINISTRATIVE APPROVAL:

POLICY AMENDED:


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.

Subject Injury Language for greater than minimal risk research Add the following to consent form subject injury language:

UNMC and Nebraska Medicine has no plans to pay for any required treatment or provide other compensation. If the subject has insurance, the insurance company may or may not pay the costs of medical treatment. If he/she does not have insurance, or if the insurance company refuses to pay, you will be expected to pay for the medical treatment.

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

HIPAA Language Add this to the HIPAA language:


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

  1. 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)

  2. 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).

  3. 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).

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

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

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

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

Section 1: General Human Research Protection Program Policies

1.5 Requirements for Research Conducted at International Sites

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for research either (1) conducted by a faculty member, staff, student, or other representative of the Organization at an international site, or (2) conducted by external investigators under the direction of a faculty member, staff, student, or other representative of the Organization.


2.0 Policy


3.0 Additional Requirements


4.0 Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 9, 2018

 INITIAL VERSION JANUARY 13, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

Revised July 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 MARCH 27, 2018

 INITIAL APRIL 11, 2016

Section 1: General Human Research Protection Program Policies

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

1.0 Purpose

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


2.0 Policy

It is the policy of the Organization that all potential financial and non-financial conflicts of interest that IRB members, IRB consultants, and IRB staff must be self-identified to the best of the individual’s knowledge and appropriately managed to prevent such conflicts from interfering with the objectivity and validity of the expedited or full board review process. The Organization does not require disclosure of the specifics of the conflict unless an exception is requested.


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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 1, 2018

 INITIAL DECEMBER 29, 2015

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 and procedure is to describe the Organization’s policy and procedure for determining the investigational activities that require IRB approval.


2.0 Policy


3.0 Definitions


4.0 HRPP Classifications of Human Subject Research


5.0 Activities Which Are Not Human Subject Research


6.0 Other Activities Deemed Not Research:

After the effective date of the Revised Rule other activities specifically defined in rev 45 CFR 46.102(l) (and listed in section 3.1A above) are deemed “not research.” Specifically, this includes:


7.0 Determination of When an Activity Constitutes Human Subject Research


8.0 Type of Review


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 18, 2019

 REVISED MARCH 3, 2018

 REVISED SEPTEMBER 27, 2017

 INITIAL MAY 6, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED MARCH 3, 2018

 REVISED SEPTEMBER 27, 2017

 INITIAL MAY 6, 2016

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


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):



ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

Revised May 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 FEBRUARY 12, 2018

 INITIAL MAY 6, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 2, 2018

 INITIAL MAY 6, 2016

Section 1: General Human Research Protection Program Policies

1.12 Sponsored Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for application of the human research protection program to sponsored research.


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 Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 8, 2018

 INITIAL MAY 6, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 2, 2018

 INITIAL JANUARY 25, 2016

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


ADMINISTRATIVE APPROVAL:
BRUCE G. GORDON, MD; IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS
CHRISTOPHER KRATOCHVIL, MD; INSTITUTIONAL OFFICIAL

POLICY AMENDED:

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL APRIL 20, 2016

Section 1: General Human Research Protection Program Policies

1.16 ORA Record Keeping Requirements

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for maintenance of documentation of IRB and ORA activities.


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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 2, 2018

 INITIAL APRIL 7, 2016

Section 1: General Human Research Protection Program Policies

1.17 Retention of Research Records

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s 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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 FEBRUARY 18, 2019

 REVISED FEBRUARY 2, 2018

 INITIAL DECEMBER 28, 2015 (ORIGINAL POLICY #3.5)

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 and procedure is to describe the Organization’s requirements for the review and approval of HRPP policies and procedures.


2.0 Policy

It is the policy of the Organization to continually assess the adequacy of existent policies and procedures 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 and Procedures


4.0 Full IRB Review of Draft HRPP Policies and Procedures


5.0 Organizational Notification of Changes to HRPP Policies and Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 28, 2018

 INITIAL JANUARY 25, 2016

Section 1: General Human Research Protection Program Policies

1.19 IRB Signature Authority

1.0 Purpose

The purpose of this policy and procedure is to describe Organization’s requirements for granting signature authority for ORA 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:


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 2, 2018

 INITIAL DECEMBER 28, 2015

Section 1: General Human Research Protection Program Policies

1.20 Community Involvement in Research & Outreach Activities

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s involvement of the community in the research process, as well as the community outreach activities in order to enhance the public’s understanding of research, obtain feedback about any community concerns and respond to questions from prospective subjects about specific research protocols available within the Organization.


2.0 Policy


3.0 Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 12, 2018

 INITIAL APRIL 14, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 28, 2018

 INITIAL DECEMBER 14, 2015 (ORIGINAL TITLE “QUALITY IMPROVEMENT ASSESSMENT FOR THE CONDUCT OF RESEARCH”)

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 and procedure 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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 2, 2018

 INITIAL APRIL 14, 2016

Section 1: General Human Research Protection Program Policies

1.23 HRPP Training Requirements

1.0 Purpose

The purpose of this policy and procedure 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.


ADMINISTRATIVE APPROVAL:


POLICY AMENDED:

Section 1: General Human Research Protection Program Policies

1.24 HRPP Training Requirements for IRB Members

1.0 Purpose

The purpose of this policy and procedure 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


6.0 Training Records

The ORA will maintain initial and continuing education training records, and copies of materials distributed to members or presented at IRB meetings. The ORA will maintain all training records for CITI Training by IRB members.


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 1, 2018

 INITIAL DECEMBER 28, 2015

Section 1: General Human Research Protection Program Policies

1.25 Financial Conflicts of Interest

1.0 Purpose

The purpose of this policy and procedure 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


3.0 Definitions


4.0 Procedures for Disclosure of Potential COI


5.0 COI Management Plan


6.0 Full IRB Review of Significant Risk 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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 13, 2018

 INITIAL APRIL 14, 2016 (PREVIOUS POLICY #3.12)

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED DECEMBER 10, 2019

 REVISED OCTOBER 11, 2019

 REVISED SEPTEMBER 5, 2018

 REVISED MARCH 3, 2018

 REVISED SEPTEMBER 27, 2017

 INITIAL MAY 6, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 18, 2019

 INITIAL JANUARY 12, 2018

Section 1: General Human Research Protection Program Policies

1.28 External Investigator Assurance

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for initiating an External Investigator Assurance (XIA).


2.0 Policy

It is the policy of the Organization that an XIA is required when the UNMC IRB is the IRB of record for non-exempt research conducted at an external site involving an external investigator (XI) who are not employed by or otherwise representing the Organization.


3.0 Definitions


4.0 Procedures for External Investigator Agreement (XIA)


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 6, 2018

 INITIAL JANUARY 12, 2018 (PREVIOUS POLICY #3.14)

Section 1: General Human Research Protection Program Policies

1.29 ClinicalTrials.gov Reporting

1.0 Purpose

The purpose of this policy and procedure is to describe the requirements and procedures for submission of clinical trials to ClinicalTrials.gov.


2.0 Policy


3.0 Definitions


4.0 Investigator Responsibilities

Per 42 CFR 11 and the NIH Policy the Responsible Party is responsible to register the ACT and/or the NIH-funded clinical trial, and fulfil reporting responsibilities as described in those regulations and NIH Policy. 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 UNMC HRPP Policies do not apply


5.0 ORA Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL MAY 31, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL FEBRUARY 5, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL FEBRUARY 26, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL JANUARY 12, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL FEBRUARY 27, 2019

 REVISED SEPTEMBER 18, 2019

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 and procedure is to describe Organization’s requirements for submission and pre-review of: 1) new IRB applications (exempt and non-exempt); 2) continuing review (CR), 3) requests for change in protocol (RFC); 4) single subject protocol deviations (SSPD), 5) adverse events (AEs); 6) reports of potential unanticipated problems involving risks to subjects or others (UPs), 7) noncompliance reports (NCR), 8) complaints (C), and 9) study completion reports (SCR).


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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 5, 2018

 INITIAL APRIL 4, 2016

Section 2: Process of Review

2.2 Full IRB Review

1.0 Purpose

The purpose of this policy and procedure 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


3.0 Definitions

Controverted issue – a human subject protection or regulatory issue which generated a significant discussion among members of the IRB. Such issues might include (but are not limited to) concerns over the acceptability of the risk-benefit relationship of the research;concerns over additional protections for a vulnerable subject population and/or whether the protocol meets the requirements of Subpart B, C, or D; concerns over areas of particular interest to the board, such as ethical access, compensation, contraception, equitable subject selection; concerns regarding investigator qualifications or compliance.

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

Revised June 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 MARCH 29, 2018

 INITIAL APRIL 4, 2016

Section 2: Process of Review

2.3 Expedited Review

1.0 Purpose

The purpose of this policy and procedure 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


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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED September 16, 2021: Revised time allowed for investigator to respond (section 8.1) to match policy 2.2

 REVISED March 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 JUNE 13, 2018

 INITIAL APRIL 11, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 AMENDED OCTOBER 4, 2018

 AMENDED JANUARY 24, 2018

 INITIAL JANUARY 5, 2016


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.

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.


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 24, 2018

 INITIAL JANUARY 11, 2016

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

ADMINISTRATIVE APPROVAL:

POLICY AMENDED:

 REVISED FEBRUARY 28, 2022 Corrected typographic errors; deleted references to pre-2019 Rule; other stylistic changes

 REVISED OCTOBER 7, 2020 Deleted exempt categories from pre-2019 Rule (section 3.1); other minor clarifications and corrections

 REVISED AUGUST 11, 2020

Clarified eligibility of children for exemption category 2

Clarified requirement for documentation of informed consent for exempt research

 REVISED FEBRUARY 5, 2018

 INITIAL JANUARY 5, 2016

Section 2: Process of Review

2.7 Continuing Review of Research

1.0 Purpose

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


2.0 Policy


3.0 Continuing Review Frequency


4.0 Criteria for Review


5.0 Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 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 SEPTEMBER 7, 2018

 INITIAL FEBRUARY 6, 2018

Section 2: Process of Review

2.8 Limited IRB Review

Note: This policy is NOT valid until after the effective date for the Revised Rule. Prior to that effective date the Organization does not perform limited IRB review.


1.0 Purpose

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


2.0 Policy

It is the policy of the Organization that research which satisfy the criteria for exemption under 45 CFR 46.104(d)(2 or 3) undergo limited IRB review if information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.


3.0 Limited IRB Review


4.0 Criteria for Approval


5.0 Procedure


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL JANUARY 24, 2018

Section 2: Process of Review

2.9 Closure of On-Going Research

1.0 Purpose

The purpose of this policy is to describe the 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 all research activities must cease when a research study has closed.


3.0 Definitions


4.0 Closure for Indadequate Accrual


5.0 Closure of Studies in Standard Follow-Up


6.0 Closure Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 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).

 INITIAL JANUARY 12, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 AMENDED JANUARY 2, 2018

 INITIAL JANUARY 8, 2016

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


4.0 Data Safety Monitoring Board


5.0 Review of the DSMP by the IRB


6.0 Review of DSMB Reports by the IRB


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 2, 2018

 INITIAL APRIL 4, 2016

Section 3: Special Issues

3.3 Privacy Interests and Confidentiality of Research Data

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for: 1) protection of privacy interests of research subjects/registry participants (hereafter referred to as participants) and 2) maintenance of confidentiality of data.


2.0 Policy


3.0 Definitions


4.0 Procedures


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 2, 2018

 INITIAL JANUARY 28, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED APRIL 9, 2018

 INITIAL JANUARY 28, 2016

Section 3: Special Issues

3.5 Subject Recruitment Through Advertisements

1.0 Purpose

The purpose of this policy and procedure 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


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 of Advertisements


8.0 IRB Review of Advertisements


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 28, 2018

 INITIAL APRIL 14, 2016

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).


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL AUGUST 23, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 26, 2018

 INITIAL DECEMBER 28, 2015

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


ADMINISTRATIVE APPROVAL:


POLICY AMENDED:

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED NOVEMBER 21, 2017

 INITIAL DECEMBER 28, 2015


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.

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 8, 2018

 INITIAL DECEMBER 28, 2015

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



ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL JANUARY 12, 2018

 REV SEPTEMBER 9, 2019

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 18, 2019

 REVISED NOVEMBER 20, 2018

 INITIAL APRIL 16, 2018

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



ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 7, 2018

 INITIAL JANUARY 12, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL FEBRUARY 5, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL FEBRUARY 28, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 26, 2018

 INITIAL JANUARY 6, 2016

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 and procedure 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


3.0 Definitions


4.0 IRB Review

In addition to review of research under HHS regulations at 45 CFR 46 (Subpart A), 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 IRB Findings under Subpart B


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 FEBRUARY 20, 2018

 INITIAL JANUARY 6, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 DECEMBER 10, 2019

 FEBRUARY 19, 2018

 INITIAL APRIL 14, 2016

Section 4: Vulnerable Populations

4.4 Research Involving Children

1.0 Purpose

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


2.0 Policy


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:


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 Assent)


10.0 Procedures for IRB Review


11.0 Documentation of Compliance with Subpart D


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 19, 2018

 INITIAL JANUARY 6, 2018

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 19, 2018

 INITIAL JANUARY 28, 2016

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 and procedure 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(a)(3), 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


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.



ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 29, 2018

 INITIAL JANUARY 20, 2016

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


ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 29, 2018

 INITIAL JANUARY 7, 2016

Section 5: Informed Consent

Section 5: Informed Consent

5.1 Obtaining Informed Consent From Research Subjects

1.0 Purpose

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


2.0 Policy


3.0 General Requirements


4.0 Elements of Informed Consent


5.0 ICF and Information Sheet Templates

All investigators are required to utilize one or more of the templates in RSS as applicable:

6.0 Process of Informed Consent