This feature is part of an ongoing series that focuses on VIICTR.org, highlighting clinical and translational research at Baylor College of Medicine.
Is it ethical to inform a research participant of clinically significant test results if he or she had previously been told that such results would not be disclosed? Is it ethical to allow a pregnant woman to participate in a research study of a drug with unknown side effects?
These are the types of questions pondered day to day by the ethics team at Baylor College of Medicine’s Center for Medical Ethics and Health Policy.
The ethics team consults with Baylor investigators, staff and students, helping them think through critical issues and ensuring that research is conducted in accordance with current medical ethics standards.
Amy McGuire, J.D., Ph.D., the Leon Jaworski Professor of Biomedical Ethics and director of the Center for Medical Ethics and Health Policy, answers questions about the scope of ethical questions that arise in biomedical research and more in this Q&A.
What is a typical research ethics consult?
Anyone can request a consult, but typically requests for consultation are made by investigators or their research staff. Sometimes we are asked pretty straightforward questions that can be answered over the phone. However, often the issues that we are asked about are very complex, and there is no clear requirement or even consensus about what to do. For those cases, we do an extensive background review of the issue as discussed in the broader ethics literature.
We also look for any legal documents or guidance that may be useful to investigators in thinking through the issue from a regulatory or legal perspective. Finally, we provide analysis of the ethical considerations that are involved and recommendations for a management strategy to address the issue that was asked about.
Often, the proposed management strategy involves some interaction with the Institutional Review Board, since they ultimately must approve protocols and ensure compliance with federal regulations. The investigator then takes that information and makes the final decision on how to proceed. We are always available, however, to talk to investigators after they review our recommendations and to provide follow up guidance or advice.
What types of ethics questions does the consult service address?
The consultations that we typically conduct involve issues for which there are no clear regulatory guidelines. For example, can a minor participate in a research study that involves taking medications for HIV prevention without parental consent?
Legally, the answer depends on whether minors can consent to preventive HIV medications without parental consent according to state law. In Texas, minors can consent to treatment for HIV, but state law is silent on whether preventive medications are considered treatment for the purposes of parental consent. We therefore would have to review the current literature and determine the ethical considerations in making that decision. We encourage people to think broadly about the issues.
The IRB would then have to decide whether parental consent is required in the context of the specific research protocol. Hopefully, however, our research and recommendations will help inform their decision making.
What is the range of ethical issues that you see in biomedical research?
The center’s website presents different categories of issues in research ethics. These are all examples of the kinds of consults we expect to receive.
- Study design — such as whether or not a randomized controlled clinical trial is ethically permissible in a specific situation, or if it is ethical to include a sham intervention (e.g., a “surgery”) in a clinical trial.
- Inclusion/exclusion criteria — such as whether it is ethically permissible to include pregnant women in a particular study or to include/exclude participants based on psychosocial factors.
- Methods of recruitment — such as how to appropriately conduct community consultations for emergency research, to know when compensation for participation should be considered, and to avoid undue influence on a potential participant.
- Consent — which deals with ethical considerations when enrolling study participants. For example, we might address the following questions: Do you need parental permission to enroll adolescents in a clinical trial? Do you need to obtain consent from family members for research using biological specimens harvested from deceased individuals who are no longer considered human subjects?
- Confidentiality — such as whether or not it is ethically permissible to breach confidentiality with a research participant or to share genetic data publicly.
There are issues for which we do not provide consultation services, such as questions about research compliance or specific research protocols, which should be directed to the Office of Research or the IRB. We also do not write informed consent documents or IRB protocols, and we do not offer legal advice. We do not address animal research issues. Other services at Baylor address questions of scientific integrity, research misconduct, and conflict of interest, and we refer investigators to those services when they have these types of questions.