Maintaining the Privacy of Research Subjects- PRO155   

procedure
 

Investigator Responsibilities

• At the time of initial review by convened or expedited procedures—Completes the FOR200 IRB application eForm describing:
  • Investigators and research staff who will be performing research procedures and obtaining consent;
  • Precautions taken in the research setting to maintain the privacy of participants during research procedures and obtaining informed consent (e.g., steps to prevent approaching participants in a public place to participate, designation of markings on files or accounts to indicate that the individual is a research participant);
  • Potential uses of collected private identifiable information or identifiable biospecimens either during or after completion of the research not included as part of the research protocol;
  • Strategies adopted to give participants control of the release of private identifiable information or identifiable biospecimens, as applicable;
  • Any information to be gathered which may be viewed by the participant as unusually sensitive or potentially objectionable in nature.
  • Sharing of any private identifiable information or identifiable biospecimens either for protocol-specific analysis, use, or potential future use.
• Submits on the amendment section of the IRB application eForm proposed changes to the protocol involving (unless the change is necessary to prevent an immediate hazard to the participants’ privacy):
  • Individuals performing research procedures and obtaining informed consent;
  • The research setting;
  • Additional uses of the information;
  • Acquisition of new information which may be viewed by the participant as unusually sensitive or potentially objectionable in nature;
  • Release of private identifiable information or identifiable biospecimens, as applicable, and the provisions for participants control of such release.
• Submits reportable problems promptly after the problem has been identified. (See POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB.)

OIRB Responsibilities

Reviewing staff at the time of initial or continuing review, or review of modifications to approved research, as applicable:

• Evaluates the submission, to determine whether the provided information is sufficient for presentation to the Reviewer.
• Requests information/materials that were not included or addressed in the submission.
• Forwards reports of problems regarding privacy that require prompt reporting (see POL006) to the Chair and to the convened IRB.

IRB Responsibilities

The IRB or experienced IRB reviewer determines there are adequate provisions to protect the privacy of participants after considering the following questions::

• Will the participants have an expectation of privacy?
• Will the participants think that the information sought is pertinent to the research?
• Will participants be comfortable in the research setting?
• Will the participants be comfortable with the research procedures?
• Will participants have adequate control of disclosure of private information, human tissues, and biological specimens?