This case discusses issues of beneficence, the ethical principle that one should avoid doing harm and seek to do good, informed consent process and the dynamics between a graduate student and the faculty on her dissertation committee.
For her dissertation, Wilma plans to conduct a prospective pregnancy study that will involve couples trying to conceive. This study will include questionnaire data as well as daily urine samples collected for three months by the female participants. The daily urine samples will be stored in the freezers of the female participants, and a nurse will pick up the samples monthly. The urine samples will be used to test for pregnancy by a sensitive assay (looking for the hormone hCG). This assay will give a number value, not a qualitative (i.e., positive or negative) value for pregnancy assessment. All women have low levels of hCG, and baseline levels are needed for each individual woman. Thus, in detecting early pregnancy, a standard value is not used. The urine samples will be tested six months to a year after their collection. The assay will determine that some of the women did not become pregnant, some had a clinically recognized pregnancy, and some may have been pregnant but were unaware of the pregnancy (i.e., the woman may have had an early spontaneous abortion).
Wilma is meeting with her adviser, Dr. Knowledge, to discuss the study proposal that will be submitted for IRB approval. During the course of the meeting, Knowledge reviews Wilma's consent form, questionnaire and protocol for collection and testing of lab samples. In reviewing Wilma's protocol, he does not see any indication that Wilma plans to inform the couples of the results of the pregnancy tests.
Knowledge tells Wilma that she needs to decide whether she will inform the couples of the results of the pregnancy tests and will indicate in the protocol reasons for her choice. The consent form also must state whether results will be available to the study participants.
Wilma is torn. She is not sure whether she should provide the results to the participants. She is worried about the consequences of some couples learning that they were actually pregnant but lost the pregnancy.
At the suggestion of Knowledge, Wilma arranges a meeting with all her committee members to discuss what she should do. Unfortunately, the other committee members' opinions conflict. Dr. Ready believes that the researcher has an obligation to provide test results to participants and emphatically tells Wilma to make that part of her protocol. Dr. Supply, on the other hand, believes that the participants should not get their results because there is no benefit to being informed of the results after the fact.
- Should Wilma notify couples about their pregnancy test values? Does Wilma have an obligation to inform all participants of their results, as Ready suggests?
- Is there any medical benefit is there in informing couples of their pregnancy test results?
- How should Wilma handle the conflicting opinions of her committee members?
Brian Schrag, ed., Research Ethics: Cases and Commentaries, Volume 5, Bloomington, Indiana: Association for Practical and Professional Ethics, 2001.