The Human Subjects Protection Process: A Subjective View

By Delva, Jorge | Social Work, April 2007 | Go to article overview

The Human Subjects Protection Process: A Subjective View


Delva, Jorge, Social Work


Currently, I am preparing to conduct a longitudinal study in another country to prospectively identify factors that may place pre-adolescents and adolescents at higher or lower risk of drug involvement. One of the concerns my colleagues and I share is whether to inform parents if a youth participant is consuming substances, particularly if a parent asks. If this were a study of risk factors associated with the incidence of cancer, we would not hesitate to inform the parent about a diagnosis. However, for now, we have resolved that we will not share any information with the parent because this would violate confidentiality, the exception being if the child and/or parent reports the child has experienced physical or sexual abuse, and this is clearly communicated to the participants in the consent process. We have promised protection of confidentiality to adolescent participants so that we may obtain more reliable and valid information.

Confidentiality is one of many areas of concern that researchers like me constantly negotiate as we make inquiries about social phenomena. The process of protecting the rights and welfare of human research subjects recruited to participate in research activities is fraught with complexities and dilemmas. I have served as a member of the institutional review board ORB) at two universities, altogether serving for more than seven years in this capacity. I have come to appreciate the role that these boards play in helping investigators more carefully think through the process of protecting study participants. Please note that my generally positive experience with the IRB process is not an indication that I fully endorse everything that IRBs do or a suggestion that the review process is flawless.

It has been my experience that researchers care greatly about informing potential study participants of the study's purpose and activities. Likewise, researchers take great pains to ensure no one is harmed as a result of his or her participation. There are numerous challenges, however, to ensure both fidelity of research and protection of the participant. In my prospective study, for example, another concern besides whether we should inform parents about their child's substance use is what to do if we learn that a child is being pressured to use drugs, has elevated depressive or anxiety symptomatology, or displays heightened aggression or other signs of behavioral problems. Should the parent be informed under these circumstances? Should we design an intervention to help the child decide that it would be a good idea to discuss this information with his or her parent or another adult? It is not uncommon for researchers to forget to identify all potential threats to confidentiality and potential harm that may result from participation in the study.

Consent is another area that warrants close inspection. Some researchers could more clearly communicate to the participant that he or she may choose not to participate, can terminate participation at any time, or may choose not to answer any questions if he or she so desires. Also, as important as we might think our studies are, I believe we can all exercise some restraint when indicating that the results of the study will serve to improve programs, services, or policies because we may inadvertently be promising too much. In all these aspects, and many more, I strongly believe that IRBs play a critical role in helping researchers successfully navigate the ethical aspects of the study including human subjects protection issues. That these boards include researchers and nonresearchers, academicians and nonacademicians, and individuals from the community also serves to bring a rich and diverse perspective on human subjects protection issues.

IRBs, too, have their downside. Although well intended, some newer IRB rules and regulations run the risk of making it impossible for some studies to be conducted. My experience says that most IRB members can be educated about the study and a positive resolution to the identified concerns can be reached through a dialogue among all stakeholders. …

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