This case discusses issues of research subjects' informed and voluntary consent, specifically whether participants must be recontacted and provide a second consent specific to the new study or whether the case author simply assumes that is an implication of the previously stated elements of the agreement.
From: Graduate Research Ethics: Cases and Commentaries - Volume 6, 2002
edited by Brian Schrag
Jim is a graduate student in the department of genetics. For his thesis research, he is mapping a gene involved in blood sugar homeostasis. His work is part of a larger multi-center study of the genetics of obesity. The larger study involves several thousand patients and includes information such as socioeconomic class, self-identified ethnicity, activity level, weight and other medical data. Blood and DNA samples are maintained in Jim's lab along with a database that links unique identifiers ' but not patient names ' with the data. The study coordinator at each site has access to the encryption key; however, the students and other researchers working on the project do not. Researchers may use the database to retrieve and enter data pertaining to the samples, but they cannot learn the identity of the individuals in the study.
The subjects/patients involved in the study were recruited at various study sites. On first contact with a potential participant, a genetic counselor explains the study and arranges for a meeting to begin the informed consent process. During this meeting, participants learn about the aims of the project, their role as subjects, and the risks and benefits involved in participation. The consent forms state that blood and DNA samples and the resulting data will be anonymized, that subjects may withdraw at any time and that samples will be used exclusively for this study. If their samples are to be used in unrelated research, the individual participants must be recontacted and go through a second consent process, specific to the new study.
Jim's project involves a subset of several hundred samples from the obesity study. One day, Renee, one of the other graduate students in the lab, approaches Jim and starts asking questions about the samples he's working with. She explains that for her work on sickle cell anemia and mutations in a hemoglobin gene in African Americans, she needs 50 ethnicity-matched control samples. Since Jim has access to such a large collection of samples, Renee asks if she can take small aliquots of some of his samples from the obesity study. She tells Jim that she will not be looking at disease in these patients, or really doing a "study" on them; she just needs them as controls, and she doesn't even need that much DNA. "Which box are they in?" Renee asks, as she heads for the freezer.
Renee was standing at the freezer with the door open when Jim said, "I'd be happy to tell you more about our samples, Renee, but you had better talk to Jane, the study coordinator, about getting consent from the obesity study participants if you really want to use them for your study. Another option," he suggested, "which might be faster, is to just order a set of anonymous samples from a commercial DNA bank. It would really be a pain to recontact all of those people just for a set of controls."
Posted 12 years and 12 months ago
Brian Schrag Indiana University
In this case, participants in an obesity study agreed to provide blood and DNA samples, given their understanding of the nature and purpose of the study, that the samples and data would be anonymized, that the samples would be used exclusively for this study, and that subjects may withdraw at any time.
The case statement is ambiguous regarding whether the subjects have further explicitly agreed that if their samples are to be used in unrelated research, the individual participants must be recontacted and provide a second consent specific to the new study or whether the case author simply assumes that is an implication of the previously stated elements of the agreement.
If Renee has her way, the subjects in the first research project will be essentially cast as control subjects in a completely different research project. It is important to remember that control subjects in research are still research subjects and the same ethical safeguards should apply to them as to any other subjects. In some cases, although perhaps not this one, the control subjects are subject to greater dangers than the experimental subjects.
It is generally understood that research subjects' informed and voluntary consent can neither be informed nor voluntary if the subjects do not have some understanding of the research project in which they are participating. Since the subjects would not even be aware of the second project, they could not be assumed to understand the study and hence could not be assumed to give informed consent. Nor could they have the option of withdrawing from a project in which they did not even know they were participating. Renee's proposed procedure thus strips them of the minimal ethical safeguards for research subjects. She fails to treat them with the respect due human participants in research. That is also an argument for claiming that there is at least an implicit agreement in the original informed consent that if their samples are to be used in unrelated research, the individual participants must be recontacted and provide a second consent specific to the new study.
The action of enrolling them in the second study also violates the terms of their original agreement, namely, that their samples will be used exclusively for the original study. If we interpret the case to indicate there was an explicit agreement that if their samples are to be used in unrelated research, the individual participants must be recontacted and provide a second consent specific to the new study, then Renee's action is a violation of their original agreement.
The data are anonymous because anonymity was one of the conditions of giving consent. The irony here is that Renee seems to assume that since the data are anonymous, that justifies the use of data without consent.
It may well be true that it would be more convenient for Renee to use these samples without the subjects' consent rather than to go through the procedure of contacting all the subjects (which may already be a violation of their confidentiality) or do as Jim suggests and obtain anonymous samples from a DNA bank. That it is most convenient does not morally justify doing it, however. There are higher moral considerations than convenience, in life in general, and in research science, in particular. That is one of the things that some scientists in Nazi Germany and in the Tuskegee syphilis study failed to understand and that has led to explicit guidelines on research on human subjects.
For all the above reasons, it is irrelevant if the consent forms are not explicit regarding the use of samples; it is irrelevant that Renee does not intend to "study" the samples; it is irrelevant that she and Jim are in the same lab.
Jim has the benefit of these data to conduct his research as a result of the subjects' agreement. He correctly perceives that he has a responsibility to protect the subjects from anyone who would violate that agreement. It is a responsibility that arises from the moral duty of anyone who gives a promise. That duty is not overridden by considerations of convenience. The moral obligation is even more stringent since the violation of this duty harms not only the subjects but, as a practice, could harm the functioning of the scientific community and all members of society who benefit from such research. His study coordinator is bound by the same duty. Jim acts wisely in suggesting an appropriate alternate action to Renee.
From: Graduate Research Ethics: Cases and Commentaries - Volume 6, 2002 edited by Brian Schrag
In very large, multi-center studies, where the researchers have no contact with the participants, but rather only with their tissue or DNA, it can be easy to forget that "samples" come from individuals with everyday lives just like their own. These individuals have given consent for the use of their samples by specific people and in specific experiments, and they may have thought very carefully about what they do and do not want done with their samples and by whom. A researcher cannot - and may not - assume that the consent applies to anything except the uses explicitly described in the IRB-approved consent document. Researchers must always try to put themselves in participants' shoes and ask how they would feel if someone took such a cavalier attitude toward something so very personal as their tissue sample or genetic information. Genetic information is one of the most personal pieces of data about any individual, and it must not be treated lightly. Furthermore, researchers have a responsibility to the scientific community to treat subjects and their samples with respect to avoid harming the interests and goals of the broader community by generating mistrust of researchers and their aims and souring the public's attitude toward science.
Some scientists view consent forms and institutional review boards (IRBs) as procedural hurdles to be surmounted - hoops to be jumped though - rather than legitimate and necessary protections for research study participants. It is important to be aware of the origin of these protections, prompted by the Nuremberg trials, the Tuskegee syphilis study and a host of other egregious breaches of trust perpetrated by members of the scientific community. Renee's intended use of the samples is relevant only in terms of the wording of the consent: If the intended use does not fall within the definitions laid out in the consent form, then it is impermissible unless new consent is sought from the study participants. Finally, anonymous control DNAs can be purchased from commercial repositories for about $50 per sample, making this a feasible alternative for most labs.