Who is a Human Subject?


Who is a Human Subject? Who has the Right to Informed Consent?

March 11, 2002

"The voluntary consent of the human subject is absolutely essential."

[Nuremberg Code, 1947]

"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) data through intervention or interaction with the individual, or

(2) identifiable private information.

[Code of Federal Regulations 45 CFR 46.102 (f);

http://www.med.umich.edu/irbmed/FederalDocuments/hhs/HHS45CFR46.html#46.102]

On October 30, 2001, the National Human Research Protection Advisory Committee (NHRPAC) signed off on recommendations redefining the term "human subject" in an effort to accommodate research that invades people’s privacy by declaring that "human subjects" are only those "who interact personally with research investigators."

Furthermore, NHRPAC determined that "Third parties about whom researchers obtain information but who have no interaction with the research" are not subjects. There were no dissenters on NHRPAC. [Full text below]

Critics and human rights advocates will, no doubt, regard NHRPAC’s tortured reasoning to be a rationalization, an effort to obscure the intended purpose, which is to deny people who fall into the category of third parties of research their status and entitlements. Indeed, it reminds me of the periodic Soviet reclassification of dissident scientists, artists, and former political leaders as "non-persons" when their views did not conform to the party line…

NHRPAC’s recommendations were crafted by using linguistic gymnastics. The road leading to the advisory panel’s recommendations was paved by a researcher at the Virginia Commonwealth University [VCU] who "sent out a 25 page questionnaire to all twins in the state. The father of one twin opened his daughter’s mail and was alarmed that she was being asked questions about HIS mental health and genitalia."

Quote from the National Institutes of Health, Coordinating Committee minutes, April 2001. http://obssr.od.nih.gov/BSSRCC/Minutes/April2001.pdf

As a result of the father’s complaint, an investigation by the (then) Office of Protection from Research Risks (OPRR, now OHRP) determined (January 2000) that the University’s institutional research review board (IRB) "did not consider that the study included the collection of individually-identifiable, private information on family members, thereby violating the Common Rule." (i.e., federal regulations governing human research). Under the Common Rule the informed consent from the parents – who are also human research subjects – is required.

That determination by OPRR set off a furor among social science researchers and service organizations that benefit financially from such research. They mounted an aggressive lobbying campaign to protect their research protocols rather than protect the rights of research subjects. The Department of Health and Human Services (DHHS) appointed (at least) two advisory panels and sub-committees to address the issue. But members of these panels of "experts" are research stakeholders; they do not reflect the interests or values of the community that will be impacted by such intrusions on the child-parent relationship. No advocates for the rights of individuals and no parents whose privacy was violated were appointed to any of these panels of "experts".

The policies recommended by NHRPAC invariably put the interests of research above the fundamental rights of individuals, of children, and families. The advisory committee disregarded entirely how its policy recommendations will undermine the child-parent relationship and the integrity of the family unit. NHRPAC panelists all voted to redefine "human subjects" and thereby to depart from the doctrine of informed consent.

The public at large is unlikely to go along with the presumptions of these stakeholders: they claim that it is O.K. to gather personal, identifiable information about living individuals – without their knowledge or informed consent. NHRPAC panelists all voted to redefine "human subjects" and thereby to depart from the doctrine of informed consent.

NHRPAC’s recommendations are a sharp departure from preceding national advisory commissions (ACHRE and NBAC) that focused on improving protections for human subjects. NHRPAC seems to facilitate research by eroding the fragile protections for human subjects. The committee would delegate all discretionary authority to IRBs – disregarding a body of recent evidence revealing systemic problems that undermine the safety of research subjects, ethical violations, and failure by IRBs to provide reliable oversight. NHRPAC would relegate to its colleagues on local IRBs authority to determine if and when to waive informed consent.

Such transfer of authority to IRBs blithely disregards judicial authority, constitutional rights, and judicial decisions. [e.g., Michigan Appellate Court and the Maryland Court of Appeals]:

http://biotech.law.umkc.edu/cases/child/in_re_AMB.htm;

http://www.garanlucow.com/medical/amb.htm

http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf

Invasion of privacy cannot be rationalized away by neither local IRBs or national advisory committees, whose membership reflects mirror images of one another. Furthermore, the historic record in America leaves little room for doubt that any government approved circumvention of informed consent would lead to all kinds of covert human experiments on unsuspecting individuals and communities.

If adopted by the federal Office of Human Research Protections, NHRPAC’s ill-advised effort to circumvent informed consent requirements would essentially overthrow the protections afforded every human being under the Nuremberg Code.

If adopted, such a policy would encourage children and adolescents to be enrolled in research without parental knowledge or permission. Such a policy will undermine family values and family relationships, which are built on love and trust. When researchers ask children to answer questions that probe into the private lives of their parents, those children are being encouraged to become agents of the state. The profound repercussions of such a policy are known – in both Nazi Germany and the Soviet Union children spied on their parents rupturing the entire fabric of civilized society.

The Alliance for Human Research Protection (AHRP) strongly objects to efforts by Department of Health and Human Services and its agencies – NIH, OHRP – and advisory committees, to circumvent the judiciary by bestowing legal authority to research review boards (IRBs). NHRPAC’s policy recommendations would lead to an erosion of the rights of individuals, which, we predict, will not stand up to a legal challenge in a court of law.

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NHRPAC POLICY RECOMMENDATION: “CLARIFICATION OF THIRD PARTY RESEARCH” [October, 2001, version]

http://ohrp.osophs.dhhs.gov/nhrpac/mtg10-01/1031NHR.txt

"Clarification of Third Parties in Research.

In regard to considering third parties in research, the parties whose roles and interests must be considered include: (1) research investigators or their agents. (2) Human subjects who interact personally with research investigators. (3) Third parties about whom researchers obtain information but who have no interaction with the research.

The determination of who is and is not a research subject rests with the IRB. 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 are providing personal or contextual information about their own lives, circumstances, perceptions, or histories, even when they make reference to others.

Simply because a third party is contemplated in research design or a third party’s information is recorded in research results does not necessarily suggest that a third party must be regarded as a research subject.

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 subjects, but on other persons as well.

In cases in which a research project’s design collects a significant amount of 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 the following factors should be considered among others. (1) The quantity of information collected on the third party; (2) the nature of information collected; (3) the sensitivity of the information collected and the possibility that information may be turned to possible harm to the third party; and (4) the possibility of recording information on third parties in such a way as to protect the identity of those parties."

January 2002 version cannot be downloaded, but can be read at: http://ohrp.osophs.dhhs.gov/nhrpac/mtg01-02/third.pdf