Author / Contributor
image for Brian Schrag
Brian Schrag More Posts
Share and Share Alike?

Added05/23/2006

Updated10/28/2015

Authoring Institution Association for Practical and Professional Ethics (APPE)
Show More Show Less
Contributor(s) Brian Schrag
Share with EEL Yes
Rights The Association for Practical and Professional Ethics (APPE) grants permission to use these case and commentary material with the citation indicated above.
Year 2002
Publisher Association for Practical and Professional Ethics
Language English
Sort By
  • Brian  Schrag

    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

  • Brian  Schrag

    Posted 12 years and 12 months ago

    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.


    References


Cite this page: "Share and Share Alike?" Online Ethics Center for Engineering 5/23/2006 OEC Accessed: Sunday, May 19, 2019 <www.onlineethics.org/Resources/gradres/gradresv6/share.aspx>