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Fundamental Ethical Principles
- Respect for persons - Individuals should be treated as capable of autonomous (independent) decision-making. Therefore, individuals must give their voluntary (un-coerced) and informed consent before participating in research studies. Persons with diminished autonomy are entitled to additional protection.
- Beneficence - Human subjects should not be exposed to unnecessary risks. Research should maximize possible benefits and minimize possible harm.
- Justice - The benefits and risks of research must be distributed fairly. This requires the fair and equitable selection of human subjects for research.
Research involving living individuals contributes to the development of everything from new medicines and surgical procedures to innovative education programs, social policies, laws, business practices, technologies, and architecture.
Assuring Safety & Confidentiality of Human Volunteers in Research
Proper conduct of University of Michigan (U-M) research involving human participants is guided by three fundamental ethical principles (shown right). These principles form the basis of federal regulations and university policy, which at a high level indicate that:
- Principal Investigators (PIs, project directors) bear primary responsibility for the proper treatment of and safeguards for human subjects.
- All members of the research team are expected to conduct research in accordance with approved ways of protecting human subjects.
- Researchers must be educated about the protection of human subjects. Acceptable training programs require certification.
- An Institutional Review Board (IRB) should assess every research study in their jurisdiction that involves human subjects to protect the rights and welfare of participants.
- Special protections are required if the human subjects in a proposed study are part of a vulnerable population (e.g., minor, cognitively impaired individuals, or prisoners).
At U-M there are nine review boards operated by four umbrella IRBs (contact information below). No research involving human subjects can begin until the applicable IRB has reviewed and approved the proposed activity.
Key considerations & concepts
Risk vs. Benefit Analysis (U-M Operations Manual, Part 3, section 4 a & b)
The IRB reviews the proposed study to verify if the risk to the subjects and/or to society as a whole outweighs the potential benefits. Risks are potential harms, usually physical or psychological. These risks may affect you, your family, or groups in society at large.
- For a PI, the risk/benefit analysis determines what protections will be required for participants if the study is approved
- For the IRB, the risk/benefit analysis determines whether the risks involved are minimized and justified
- For you, the risk/benefit analysis helps you determine whether you want to participate in the study
Informed Consent (U-M Operations Manual Part 3, section 4d)
Informed consent refers to the communication process that allows individuals to make a knowledgeable choice to voluntarily participate in the research study, decline to participate, or to withdraw at any time for any reason after the study has started without penalty. As a potential participant, you must be provided with complete information about the study; understand this information; and feel free to decide whether or not to voluntarily participate.
In general, you should be given written information (verbal or other format is acceptable only if approved by the IRB) explaining that the study involves research, the purpose of that research, and including the following details to help you decide whether or not to participate:
(Adapted from Informed Consent: The Consumer's Guide To The Risks And Benefits Of Volunteering For Clinical Trials, Kenneth Getz and Deborah Borfitz)
- The risks, side effects or discomforts that you might reasonably expect
- The benefits you and others might reasonably expect
- The study's duration and what will happen in the study
- Whether any procedures, drugs or devices will be used that are different from those used in standard medical treatment
- Appropriate alternative treatments that might be advantageous to you
- Available treatments or compensation, if complications occur during the study
- Whether your health information will be used in the research, with an expiration date for your authorized use this information, and information how to revoke authorization
- The risks to the your privacy and confidentiality
- Contact information for the IRB, if you have any concerns
You are allowed to ask any questions about the study before giving consent and at any time during the course of the study. You must be allowed ample time, without pressure, to decide whether to consent (agree) to participate or not in the study. You should receive a signed and dated copy of the informed consent form.
Privacy & Confidentiality (U-M Operations Manual, Part 3, section 4f)
Privacy and confidentiality of the subjects is to be maintained throughout the research process. Research involving particularly sensitive information requires additional privacy protections for subjects. Each project needs to develop and enforce a mechanism for safeguarding the privacy and confidentiality of its subjects that all members of the study team (PI, students, staff, visiting scholars, etc.) are responsible for applying. In general, study team members:
- DO NOT reveal a participant's name, address, telephone number, or other identifying information (or that of a family member, employer, or other person connected to a subject) to any person other than a member of the research team/staff directly connected to the study or an authorized official involved in oversight.
- DO NOT reveal the contents and substance of the information gathered in the study regarding any identifiable subject (or family member, employer, or other person connected to a subject) to any person other than a member of the research team/staff directly connected to the study, except as authorized by a PI or their designate, or authorized officials involved in oversight.
- DO NOT contact any subject (or family member, employer, or other person connected to a subject) except as authorized by the approved protocol.
- DO NOT release a data set (including for unrestricted public use or for other, unrestricted, uses) except in accordance with approved and established policies and procedures.
All persons not part of the research team/staff who have access to subjects' data (other than unrestricted public release data sets) adhere to the same standards in protecting subjects' privacy, anonymity, and confidentiality.
State and federal law provide exceptions to a subject's right to privacy and confidentiality. For example, if evidence of physical or sexual abuse of any individual with diminished autonomy (e.g., child, elder, disabled) comes to the attention of any member of the research project, there is a legal requirement in the State of Michigan to report that evidence to the appropriate authorities. Some infectious disease conditions may need to be reported to health authorities. If subjects are paid, federal tax law and regulations require the study to document such payments.
See the Research Study Participant FAQ for basic information.
See Clinical Trials Participant FAQ for Parents for answers to basic questions governing a child's participation in a clinical study.
U-M Institutional Review Boards (IRBs)
IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)
If you have questions, concerns, or suggestions about human research protections at U-M but you're not sure who to contact, email us at firstname.lastname@example.org.