150. Additional Requirements for VA Research Involving Vulnerable Populations

Updated Oct. 4, 2019

The University IRB uses review worksheets to document DHHS requirements (in Subparts B, C, and D) for additional protections and population-specific findings for VA Research involving pregnant women, fetuses, and neonates; prisoners; and children; and to evaluate protections and VA requirements for conditionally vulnerable populations.

(VA researchers are advised to consult VA Handbook 1200.05 and relevant VA guidance, or to contact the VASNHCS Research Office for more information about conducting research with vulnerable populations.)

VA Research Involving Pregnant Women, Fetuses or Neonates; and Women of Childbearing Potential

The University IRB applies DHHS requirements for Subpart B and DHHS criteria for IRB approval to VA Research involving pregnant women, fetuses, or neonates with the following additional limitations:

  • Research involving in vitro fertilization is not allowed.
  • Research involving stem cells shall be governed by the policy set by NIH.
  • Research involving the provision of in vitro fertilization services is not allowed.
  • Research in which the focus is either a fetus, human fetal tissue, in-utero, or ex-utero, is not allowed.
  • Research involving prospective observational and retrospective record review studies for fetuses, human fetal tissue, and neonates is allowed.
  • Intervention studies involving neonates or neonatal outcomes is prohibited.
  • The involvement of pregnant women in greater than minimal risk VA Research requires prior written certification from the VASNHCS Facility Director attesting to the facility’s capacity to respond to obstetric emergencies.

VHA ORD Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy... (04/18/2014)

When relevant, risks to women of childbearing potential should be addressed during the consent process. The University IRB considers new guidance from ORD for safety monitoring for pregnancy progress and outcomes when pregnancy is not the research focus. The guidance applies to collection of data from or about the following populations:

  • female subjects who become pregnant while enrolled in VA Research,
  • pregnant partners of male subjects in VA research, and
  • newborn infants born to female participants or to partners of male participants in VA Research (requires approval from the VASNHCS Facility Director).

Collecting Pregnancy Information from/about Female Participants Who Become Pregnant

For VA Research involving drugs or devices, the intervention should cease for any participant who becomes pregnant as soon as the PI is made aware of the pregnancy. In such cases, study sponsors may request or recommend researchers monitor the pregnancy for safety. Pregnant participants may decline to be monitored after being withdrawn from the study.

For safety monitoring, researchers may continue with data collection and follow-up activities as described in the IRB-approved research plan and informed consent documents. The collection of data after a pregnant participant has been withdrawn from the study would constitute human subject research.

Collecting Pregnancy Information from/about Female Partners of Male Participants

A female partner of a male participant in VASNHCS research may become pregnant during the interval her partner is participating in a study. For clinical investigations involving drugs or devices, the PI, sponsor, or both may want to obtain information about the progress and outcomes of the pregnancy.

If information is collected through intervention or interaction with, or by obtaining identifiable private information about a pregnant partner, the female partner becomes a human subject. The research application must describe the research activities involving pregnant partners. IRB requirements for informed consent apply. HIPAA may also apply.

Collecting Information about the Newborn Infant

If information is collected through intervention or interaction with, or by obtaining identifiable private information about a newborn infant of a participant enrolled in VA research, the infant would be a human subject. Requirements for IRB research involving children and informed consent apply. HIPAA may also apply.

The research application and consent documents must describe the collection of information about the infant. Following IRB review and approval of the collection of information about the newborn, the PI must obtain approval from the VASNHCS Facility Director before data about the newborn may be collected.

VA Research Involving Prisoners

The University IRB applies DHHS requirements for Subpart C and DHHS criteria for IRB approval to VA Research involving prisoners with the following additional requirements and prohibitions:

  • VA Research with prisoners of war is prohibited.
  • A waiver must be obtained from the CRADO to conduct VA Research involving prisoners as participants.

Incarceration of a Participant in VA Research

See IRB Policy Manual for information about unexpected incarceration of a research participant.

For VA research, if a participant becomes incarcerated during the course of a study and continued participation is in the individual’s best interest, the requirement for a waiver from the CRADO will apply.

VA Research Involving Children

The University IRB applies DHHS requirements for Subpart D and DHHS criteria for IRB approval to VA Research involving children, including research involving biological specimens or data obtained from children (whether identified or de-identified), with the following additional requirements:

  • PIs must obtain written approval from the VASNHCS Facility Director, including certification of the facility’s capacity to respond to pediatric emergencies (for interventional research).
  • The IRB must determine risk is no more than minimal.
  • IRB meeting minutes document IRB risk determinations and consent waivers (if applicable).
  • Review worksheets document determinations related to informed consent, permission, and assent; investigators’ qualifications to conduct research involving children; and additional safeguards incorporated into the protocol, if any.

Conditionally Vulnerable Populations in VA Research

Individuals or populations that may be considered permanently or temporarily vulnerable due to conditions or circumstances include persons who

  • are susceptible to coercion or undue influence (e.g., homeless or institutionalized persons, students or employees, patients with limited or no treatment options, persons who are socially or economically disadvantaged);
  • may not be able to comprehend what they may experience during the research and the risks of participation (e.g., those who are educationally disadvantaged; or who have cognitive impairment, dementia, schizophrenia, or depression);
  • have increased susceptibility to harm from the procedures of the specific study under review (e.g., individuals answering study survey questions about sexual assault); or
  • are at risk for economic, social, or legal consequences from the study (e.g., participants who answer survey questions about their drug use or HIV status).

Adults with Cognitive Impairment

The University’s IRB policy for adults with cognitive impairment is augmented by additional considerations for VA Research involving participants whose consent capacity may be impaired.

Decision-Making Capacity

Situations of uncertain capacity occur when research involves adults with cognitive impairment and

  • no documentation is in the medical record specifying the individual lacks (or possesses) decision-making capacity; or
  • the individual has not been ruled incompetent by a court of law.

If there is any question as to whether a prospective adult participant has decision-making capacity, VA researchers must consult with a qualified practitioner (who may be a member of the research team) before proceeding with the consent process.

Fluctuating Decision-Making Capacity

Research involving individuals at high risk for fluctuating decision-making capacity must include provisions for a qualified practitioner to determine each individual’s ability to consent prior to enrollment and again periodically, as dictated by participant’s condition.

Additional Requirements for IRB Approval of VA Research Involving Persons with Impaired Consent Capacity

Research involving adults who are unable to consent may occur only when the IRB determines the proposed research:

  • Does not present greater than minimal risk, or
  • Presents a greater probability of direct benefit to the participant than harm to the participant, or
  • Poses greater than minimal risk and no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the participant’s disorder or condition that is of vital importance to understanding or amelioration of the participant’s disorder or condition.

In addition, one of the following statements must be true for the IRB to approve the research:

  • The research cannot be performed solely with persons who possess decision-making capacity and the focus of the research is the disorder leading to the subjects’ lack of decision-making capacity, whether or not the lack of capacity is being evaluated (e.g., an individual who lacks decision-making capacity as the result of a stroke can participate in a study of cardiovascular effects of a stroke); OR
  • The focus of the research is not directly related to the subjects’ lack of decision-making capacity but the investigator has presented a compelling argument for including such subjects (e.g., transmission of methicillin-resistant staphylococcus aureus infections in a nursing home where both individuals with and without decision-making capacity are affected).

Consent by a Legally Authorized Representative

Consent by a Legally Authorized Representative (LAR) must be limited to situations whereby the prospective participant is incompetent or has impaired decision-making capacity, as determined and documented in the participant’s research record.

NOTE: University and affiliate researchers must comply with Nevada state law regarding guardian consent for research which is stricter than VA regulations (see NRS 159.0805 in the IRB Policy manual for Nevada State Laws for Human Research).

Acceptable Legally Authorized Representatives for Participants in VA Research

  • Healthcare agent such as an individual named by an individual in a durable power of attorney for health care
  • Legal or special guardian
  • Next of kin or close relative of the patient who is at least 18 years old, prioritized as follows: spouse, child, parent, sibling, grandparent, or grandchild;
  • In the absence of the aforementioned, a close friend, unless otherwise specified by applicable state law.

Additional VA Requirements for a Consent Process Using an LAR

  • PI must identify who may provide consent as LAR for those who lack decision-making capacity at the time of their participation in the study (within the confines of Nevada State law).
  • The LAR must be informed of all disclosures to be made to the prospective participant.
  • The LAR must be told that that her/his obligation is to determine what the participant would do if able to make an informed decision, or if the prospective participant’s wishes cannot be determined, to choose what is in the participant’s best interest
  • When feasible, the PI must explain the proposed research to the prospective participant even when the participant’s LAR gives consent, and must include procedures for respecting dissent.
  • If the participant regains decision-making capacity, the PI or designee must repeat the consent process with the participant, and obtain the participant’s agreement to continue with the study.