According to NIH’s Office of Human Subjects Research, ethical guidelines for conducting clinical research fall into three basic categories: informed consent, assessment of risks and benefits, and selection of subjects.
Informed Consent
Obtaining informed consent from study participants is one of the most important tasks of the clinical research process. Not only must you get participants to agree to be a part of the study, but you must also educate participants and p rovide them with a clear understanding of what the research will involve. The consent process begins even before participants become involved in the study. In initial advertisements, information about the study must be presented in clear, understandable language without technical jargon so that potential participants can know a bit about the study before it is explained to them. Study participants must provide informed consent before they are involved in any research activity, and the informed consent process continues throughout the study in the form of regular communication between participants and the project manager. At no point in the study should participants feel as if they don’t know what is going on.
Decide what steps you’ll take to obtain informed consent, and stick to that process. Here are some general guidelines for that process:
- Provide general information about the study.
- Allow potential participants to contact you if they’re interested in the study.
- Meet with potential participants to discuss and answer any questions about the study.
- Provide potential participants with information and give them time to decide whether they want to join the study.
- Answer more questions, if necessary.
- Obtain the signed consent document.
Researchers should carefully document the informed consent process. According to Pitt’s Research Conduct and Compliance Office, which oversees and facilitates the conduct of ethical and regulation-compliant human and animal subject research, investigators should document who was present when the consent form was signed; that the study and any potential risks were explained; that all questions were answered; that the participant’s comprehension level was measured and how; and that the subject agrees to participate in the study. (For a sample of how to document the informed consent process, click here.)
Chapter 8 of the University of Pittsburgh’s Institutional Review Board Manual is titled The Informed Consent Process and Document – Requirements and Format; it provides a comprehensive description of general requirements, basic and additional elements of informed consent, and specific instructions and requirements for the informed consent document. (Note that informed consent forms need to be stored in a double-lock system and not with participants’ medical records.) In addition, here are some other resources for information about informed consent:
- Federal regulations on the protection of human subjects (45 CFR 46.116) include General Requirements for Informed Consent as well as Additional Protections for Children Involved as Subjects in Research.
- The Office of Human Research Protections of the U.S. Department of Health and Human Services provides answers to frequently asked questions about informed consent.
- Information sheets titled A Guide to Informed Consent and Guidelines for Writing Informed Consent Documents are maintained by the U.S. Food and Drug Administration and NIH’s Office of Human Subjects Research, respectively.
Assessments of Risks and Benefits
Falling under the scope of beneficience—defined by the Belmont Report as a two-fold obligation for clinical researchers to (1) do no harm and (2) maximize possible benefits and minimize possible harms to study participants—all research studies need to be assessed as to how risky participation will be to research subjects. The basic rule is that any potential risk should be significantly outweighed by the possible benefits of being part of the research. Any risks need to be clearly indicated and pointed out in the informed consent process.
Selection of Subjects
Just as you should choose potential study participants based on the needs of the research project, ethics and justice should also guide whom you select or pursue as a study participant. Principal investigators should guard against recruiting based solely on whom they think would benefit from the research, and they shouldn’t recruit from vulnerable populations—the severely mentally infirm or prisoners, for instance—unless certain conditions are met. However, the appropriate recruitment of research subjects may not always be clear. For example:
- Is it ethical to take a person with an obvious reading problem when you know she or he may not have fully understood the consent, but you really need another participant?
- What if people meet three inclusion criteria but not the fourth criterion—do you still recruit them?
- Is it ethical to tell potential participants that your study is the “best” treatment for them?
For information or guidance on these issues and similar matters in regard to ethics and clinical research, contact CTSI.
