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

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

 Revised 9/25/2024 – added that research involving fetuses and neonates (nonviable or of uncertain viability) will be reviewed and conducted in accordance with applicable state law (section 2.3). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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

Note: In accordance with OHRP guidance, application of the regulatory definition of prisoner includes the following: 1) Individuals detained in a residential facility for court-ordered substance abuse treatment; or 2) Individuals with psychiatric illnesses that have been committed involuntarily to an institution as an alternative to criminal prosecution or incarceration.

Note: Individuals who are on probation or parole regardless of whether they are required to wear a monitoring device are generally not considered prisoners. Individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness are also not considered prisoners. However, such subjects are vulnerable and, therefore, must be afforded additional appropriate protections as required by 45 CFR 46.111(b).

Note: The IRB interprets the term “healthy persons” to mean the average healthy person in the general population who is not a prisoner.


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

 Revised: 01/17/2024 – specified that the prisoner representative review must be presented at a convened meeting either oral or written (section 4.2); clarified who makes determination whether an enrolled subject is a prisoner (section 9.1.1); clarified that executive chair or designee may provide temporary approval for a prisoner to continue only if research is not subject to 45 CFR 46 subpart C (section 9.1.1.1.1); clarified that convened IRB only may allow continuation of prisoner in research for research subject to 45 CFR 46 subpart C (section 9.1.1.1.2); calaried process if convened IRB cannot find conditions of 45 CFR 46 subpart C met for already enrolled subject (9.1.1.1.3.); corrected numbering errors. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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

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

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 or IAS


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, they must be fully informed about the research and the circumstances of their enrollment. Their 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, they must be fully informed about the research and the circumstances of their 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

 Revised 11/27/2024 - modified definition of capacity to remove extraneous language; revised “Cognitively impaired” to “decisionally impaired”; added reference to Children’s Nebraska policy (Consent for Treatment); stylistic and other minor changes. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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