Information about Human Volunteers in Research
Privacy and Confidentiality
Ethical conduct of research requires protecting the privacy of the individual and the maintenance of confidentiality.
Individuals can be sensitive about sharing aspects of their lives. Disclosure of sensitive types of information about an individual can threaten that individual's standing in the community or place themselves at risk of legal or economic penalties. Subjects' concerns about privacy or confidentiality can lead them to decline participation in the study, to compromise the information they provide and ultimately threaten the research capabilities of the greater research community. For all of these reasons, the IRB must carefully review all aspects of a study to assure that the privacy and confidentiality of the subjects is maintained throughout the research process. The IRB may ask for protocol changes or disallow research when there are concerns about privacy or confidentiality.
Each research project needs to develop and enforce a mechanism for safeguarding the privacy and confidentiality of its subjects. The mechanism applies to all members of the research team/staff (students, clericals, administrators, assistants, visiting scholars, PI -- whether inside or outside the University). The mechanism should, at a minimum, assure that members of the research team/staff:
- DO NOT reveal the name, address, telephone number, or other identifying information of any research subject (or family member, employer, or other person connected to a subject or other informant) to any person other than a member of the research team/staff directly connected to the study in which the subject is participating and authorized officials 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 or other informant) to any person other than a member of the research team/staff directly connected to the study in which the subject is participating, 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 or other informant) 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.
Furthermore, members of the research team/staff MUST ENSURE that:
- 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 as the research team/staff in protecting subjects' privacy, anonymity, and confidentiality.
State and Federal law provide some exceptions to a subject's right to privacy and confidentiality. For example, if, in the course of the research, 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 some jurisdictions (including the state of Michigan) to report that evidence to the appropriate authorities. Some infectious disease conditions may need to be reported to health authorities. Also, if subjects are paid, federal tax law and regulations require the study to document such payments.
If an investigator is conducting research involving particularly sensitive information, he or she may be required to provide additional privacy protections for subjects.
June 1, 2010