There are a number of research populations described in the Federal regulations as "vulnerable" or that require additional consideration or protection. "Vulnerable" or "special" classes of subjects include:
pregnant women, human fetuses and neonates,
cognitively impaired persons
students and employees
economically and/or educationally disadvantaged
Terminally Ill Subjects
In addition, the regulations outline specific provisions for research involving:
- pregnant women, and in vitro fertilization
- prisoners, and
Vulnerable Subjects and Exempt Research
Due to the vulnerable nature of the population the exemptions in 45 CFR 46.101(b) do not apply to certain types of research involving children and prisoners, Subparts C and D.
Specifically, the exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
In addition, exemption from IRB review should be utilized conservatively when applied to research involving special classes of subjects who are not be defined by regulation as vulnerable.
The following section is a brief discussion regarding the "vulnerable" subject populations.
In reviewing these research projects, the IRB determines if the inclusion of the vulnerable population is adequately justified and that safeguards are implemented to minimize risks unique to each population.
During it's review the IRB must determine which of the following categories the research would involve:
- the research does not involve more than minimal risk to the subject;
- the research is likely to benefit the subject directly, even if the risks are considered to be more than minimal;
- the research involves greater than minimal risk with no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition; or
- research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of the subject.
Requests for approval of any research that exposes vulnerable populations to risks that do not meet one of the above criteria must be submitted to the United States Secretary of Health and Human Services for review and approval.
Special protections are essential to guide research involving vulnerable persons. In order to review projects involving the use of vulnerable populations as specified in 45CFR46, an IRB must have present at its meeting an advocate for these subjects.
The mere presence of the appearance of vulnerability should not lead to a presumption that a person is incapable of making a decision regarding participation in research and of giving valid informed consent. Yet sometimes these conditions do impair the decision-making capacity required to give a valid informed consent, raising ethical concerns about the vulnerability of persons in such conditions in research.
AIDS/ HIV+ Subjects
Subjects involved in HIV-related research (HIV-infected persons and persons at risk of HIV-infection) are particularly vulnerable because of their disease status and because the disease disproportionately affects certain populations.
Principal Investigators should be aware of the numerous ethical concerns presented by HIV, including considerations of confidentiality, privacy and justice and follow Virginia State regulations.
An overriding concern in HIV research is confidentiality and privacy, since breaches of confidentiality could have severe adverse consequences.
In ensuring that research adequately protects subjects' confidentiality, Principal Investigators should consider the following criteria:
- where identifiers are not required by the study design, they are not to be recorded.
- if identifiers are recorded, they should be separated, to the greatest extent possible, from data and securely stored, with linkage restored only if necessary to conduct the research.
- if subjects will be given a fair and clear explanation of how information about them will be handled, including whether and how the information will be recorded in their medical records.
- whether the protocol will specifically set forth how to respond to attempts to force disclosure of subjects' medical records or requests by third parties who have authorizations for disclosure signed by subjects; and
- whether the protocol will clearly state what information will be recorded, who is entitled to see records with identifiers, and whether any state laws require the reporting of HIV infection or the disclosure of other information.
Sharing of HIV Test Results
In research protocols that involve HIV testing, investigators should consider the circumstances under which subjects should or must be told of their HIV sero status. In general, IRB policy requires that individuals whose test results are associated with personal identifiers be informed of their HIV test results and provided the opportunity to receive counseling, unless the situation is a special circumstance calling for an exception ( e.g. , compelling evidence that a given individual would attempt suicide if informed that he/she is seropositive). When individuals will be informed of their HIV antibody test results, Principal Investigators should ensure that the protocol provides for appropriate pre-test and post-test counseling.
*Taken from UVa IRB-HSR Research Guidance