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Does the researcher make adequate provisions to protect the privacy interests of participants?

Robert Hood

03/06/2008 04:18 pm

IRB Committee Member Help: Does the researcher make adequate provisions to protect the privacy interests of participants?

Belmont principle Respect for Persons
Where to start: initial application Check Subjects Question F
Where to start: continuing review application Questions A and B
Required IRB determinations Describe specific procedures to ensure the privacy of participants.
The research makes adequate provisions to protect the privacy interests of participants.
Points to consider Privacy refers to persons and their interest in controlling access to themselves.Regulations do not define privacy; the ethics and law literatures contain various definitions. Privacy is seen as the limitations on other’s access to the individual; as the condition of being protected from unwanted access by others; as selective control over access to oneself or one’s group by others; and as the exclusive access to a realm of one’s own.Case law holds that Florida’s privacy guarantees are stronger than federal privacy protections.Have the researchers described how they will protect privacy interests, and demonstrated they have given consideration to how participants in research may want to control:
  • the time they give information (certain times are emotionally significant, such as shortly after giving birth, and people have an interest in limiting other’s access, or being protected from intrusions from others, during such times)
  • the place they give information (people have greater expectations of their ability to control access, and be free from unwanted intrusions, in certain places, such as homes, or in healthcare clinics.Even in public areas, people retain expectations about privacy; for example, that others will not draw attention to them; that they will not be followed, or watched, or photographed using telephoto lenses; or monitored while entering or leaving private places (such as bars or office buildings); and that others will not eavesdrop on communications or use sensitive microphones to monitor public areas, or monitor electronic communications (for example by wiretapping or monitoring computer networks—though this may be an expectation that data will be protected; see confidentiality).
  • the nature of the information they by provide (people expect they will not be forced to disclose information, or that information they provide about themselves will not be disclosed to others). People expect that information they consider private—which may vary depending on the person or group—will be protected.
  • the nature of research experiences that are provided to them; people have an expectation that they will be given an opportunity to know what will happen during research
Accreditation Element Standard II-6: Element II.6.A: The Research Review Unit has written policies and procedures to evaluate the proposed arrangements for protecting the privacy interests of research participants during and after their involvement in the research.
DOH Policy  
Regulations 45 CFR §46.111(a)(7); 21 CFR §56.111(a)(7)
Guidance None
OHRP Guidebook Chapter 3: Basic IRB Review, Section D: Privacy and Confidentiality

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