Third-party status gets further revision
The National Human Research Protections Advisory Committee (NHRPAC) clarified the status of third parties as human subjects at its January meeting. The committee agreed to a consensus statement, which was sent to Secretary of Health and Human Services Secretary Tommy Thompson, the assistant secretary for Health, and the Office for Human Research Protections for consideration. However, the statement does not represent official policies of either organization. Following is the statement:
Clarification of the Status of Third Parties When Referenced by Human Subjects in Research
These recommendations are meant to clarify issues specifically dealing with information provided by a human subject about someone else, such as a third party. It is not meant to readdress situations where information about a research subject is gathered through indirect means, such as a chart review, as these situations are already covered in the existing regulation (45 CFR part 46).
In regard to considering third parties in research, parties whose roles and interests must be considered include:
• investigators or their agents;
• human subjects who interact personally with investigators;
• third parties, about whom researchers obtain information from human subjects but who themselves have no interaction with research investigators or their agents.
The determination of who is and is not a human subject rests with the IRB. The requirement of informed consent, or waiver of consent, pertains only to those deemed to be human subjects by IRBs.
In most instances, the identity of human subjects of research is clear. Whether through interaction, intervention, or identifiable private information, persons are human subjects when they provide personal or contextual information about their own lives, circumstances, perceptions, or histories even when they make reference to others.
Simply because reference to a third party is contemplated in a research design or a third party’s information is recorded in research records does not necessarily suggest that a third party must be registered as a research subject.
Nevertheless, investigators, in designing and proposing research projects, and IRBs, in considering and reviewing research projects and in conducting continuing review, should consider how the research design might focus not only on the identified human subjects but on other persons as well. In cases in which a research project’s design collects a significant amount of private information in identified form on third parties, the investigator and IRB should consider whether any of these third parties should be regarded and treated as research subjects themselves.
In making this determination, IRBs should consider the following factors, among others:
• the quantity of information collected about the third party;
• the nature of the information collected, including the sensitivity of the information collected and the possibility that such information might cause harm to the third party;
• the ability of investigators to record information on third parties in a manner that protects the identity of those parties;
• the possibility that classification of a third party as a human subject may have an impact on the rights or welfare of the originally designated human subject and requires the IRB to deal with this issue to protect the interests of both the original human subject and the third parties.
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