The following populations are considered categorically vulnerable and have specific VA requirements for their inclusion in research:

  • Pregnant Persons, Human Fetuses, and Neonates
  • Prisoners
  • Children
  • Subjects who Lack Decision-making Capacity

Prisoners

Research involving prisoners cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the CRADO.

Waiver requests must be submitted electronically to the CRADO by the VA medical facility Director with the following documents:

  1. A letter from the VA medical facility Director supporting the conduct of the VA study involving prisoners;
  2. Rationale for conducting the research involving prisoners to include additional ethical protections taken by the proposed research for prisoners to make voluntary and uncoerced decisions whether or not to participate as subjects in research;
  3. Documentation of the VA investigator’s qualifications to conduct the research involving prisoners, such as a biosketch and a list of all research team members;
  4. Location of institutions where the research is proposed to be conducted;
  5. A copy of the IRB approval letter specifically documenting its review determinations according to 45 CFR 46.305(a);
  6. A copy of the IRB minutes approving the research with documentation that at least one member of the IRB included a prisoner or a prisoner representative for the review of the research;
  7. A copy of the IRB-approved research study;
  8. A copy of the IRB-approved informed consent document; and
  9. A copy of the written HIPAA authorization.

If such a waiver is granted, the research must comply with the requirements of 45 CFR 46.301 – 46.306.

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Children

  • Research involving children must not present greater than minimal risk.
  • The VA medical facility Director must approve participation in the proposed research that includes children.
  • Research involving biological specimens or data obtained from children is considered to be research involving children even if de-identified. If the biological specimens or data were previously collected, they must have been collected under applicable policies and ethical guidelines.
  • The IRB must have the appropriate expertise to evaluate VA research involving children and must comply with the requirements of 45 CFR 46.401 – 46.404 and 46.408.

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Pregnant persons, Human Fetuses and Neonates as Subjects

  • Neonates: Interventional research enrolling neonates cannot be conducted by VA investigators while on official duty, or at VA facilities, or at VA approved off-site facilities. VA investigators may conduct research involving noninvasive monitoring of neonates if the research is determined by the IRB to be minimal risk. Prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted. The VA medical facility Director must certify that the medical facility has sufficient expertise in neonatal health to conduct the proposed research.
  • Pregnant persons: The VA medical facility Director must certify that the medical facility has sufficient expertise in women’s health to conduct the proposed research if the research includes interventional studies or invasive monitoring of pregnant persons as subjects.
  • Research that involves provision of in vitro fertilization services can be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities. This includes prospective and retrospective research involving provision of or the enhancement of FDA-approved methods of in vitro fertilization for studies involving consenting subjects, both male and female, undergoing or who have undergone in vitro fertilization for the treatment of certain forms of human infertility. In vitro fertilization is any fertilization of human ova that occurs outside the body of a female, either through a mixture of donor human sperm and ova or by any other means.
  • Prospective and retrospective studies that enroll or include pregnant subjects who conceived through in vitro fertilization or other artificial reproductive technologies are permitted.
  • Research that uses human fetal tissue or that focuses on either a fetus, or human fetal tissue, in-utero or ex-utero cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities. Use of stem cells shall be governed by the policy set by NIH for recipients of NIH research funding.

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Persons Who Lack Decision-Making Capacity

  • The protocol must include a plan, that it is appropriate given the population and setting of the research, for how investigators will determine when a legally authorized representative will be required to provide informed consent. In general, the research staff must perform or obtain and document a clinical assessment of decision-making capacity for any subject suspected of lacking decision-making capacity.
  • When the potential subject is determined to lack decision-making capacity, investigators must obtain consent from the LAR of the subject (i.e., surrogate consent). NOTE: Investigators and IRBs have a responsibility to consult with the Office of General Counsel (OGC) regarding state or local requirements for surrogate consent for research that may supersede VA requirements.
  • The following persons are authorized to consent on behalf of persons who lack decision-making capacity in the following order of priority:
    • Health care agent (i.e., an individual named by the subject in a Durable Power of Attorney for Health Care);
    • Legal guardian or special guardian;
    • Next of kin: a close relative of the patient 18 years of age or older, in the following priority: spouse, child, parent, sibling, grandparent, or grandchild; or
    • Close friend.
  • If feasible, the investigator must explain the proposed research to the prospective research subject even when the legally authorized representative gives consent. Although unable to provide informed consent, some persons may resist participating in a research protocol approved by their representatives. Under no circumstances may a subject be forced or coerced to participate in a research study even if the LAR has provided consent.
  • Legally authorized representatives must be told that their obligation is to try to determine what the subjects would do if able to make an informed decision. If the potential subjects’ wishes cannot be determined, the legally authorized representatives must be told they are responsible for determining what is in the subjects’ best interest.

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