Human Subject Research concluded, a benefit or increased risk has been demonstrated and there is no longer any justification for increased exposure to risk. 46 Ethical Dilemmas in Research Integrity
Human Subject Research Informed Consent for Saving Research Data In a laboratory exercise, graduate students draw samples of their own blood and use these to perform various tests. Afterward, the instructor tells the class that he wishes to collect their test results for use as baseline data in a clinical study. Anyone may decline to participate, he says. Is informed consent from the students needed? What if, instead of their test results, the instructor also asked for the leftover blood samples? Would it matter if the data and/or samples were unlabelled and anonymous? R3H says: Informed consent cannot be obtained in this circumstance and the data/samples may not be used. Consent cannot be obtained since the consent cannot be considered free. This is roughly analogous to general rule that a prisoner may not give informed consent because of the expectation of some benefit, even it is explicitly stated that no favoritism will be granted. In this case there may be an element of coercion here since the perception may be that a grade will be affected, positively or negatively, as it relates to participation. Even more particularly, in the context of a required class in which the grade is an important outcome with long term ramifications, the element of potential coercion is even stronger. The grade depends on the good will of the instructor at some level. There is potential for a real conflict of interest here, even if it is not perceived as such by the instructor. Ethical Dilemmas in Research Integrity 47
Human Subject Research Appropriate Use of Test Data A government agency is training students from local law enforcement agencies in use of a new device for matching DNA samples. Trainees collect specimens of their own DNA in various ways and then analyze these to learn how the mode of collection influences the likelihood and reliability of a match. At the end of the course, and unbeknownst to participants, everyone’s DNA profile is entered into the agency database. Is this appropriate? Would it be more appropriate if consent were obtained? Would it be more appropriate if the data were fingerprints, rather than DNA samples? R3H says: Under no circumstance can personal information be taken and incorporated into a database, government or otherwise, without knowledge and consent. This is not only unethical on its face, it is illegal and the government itself is not exempt under its own US code. It does not make any difference if it is DNA or fingerprints. If consent is not knowingly and freely given, it cannot be ethically done. If consent were obtained, this might be permissible, although there are concerns about implied or actual coercion. This would depend on the specifics of the situation and consent.
- Spring '14