Procedure on Maintaining the Privacy of Research Subjects - IRB PRO155

Abstract:
This procedure outlines the responsibilities of the investigator, IRB, and OIRB for maintaining the privacy of research subjects.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO155
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure on Maintaining the Privacy of Research Subjects

PROCEDURE

Investigator Responsibilities

The Investigator:

  • At the time of initial review by convened or expedited procedures—Completes the FOR200 Human Subjects Protocol (HSP) 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 information 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 information, human tissues, or biological specimens, as applicable;
    • Any information to be gathered which may be viewed by the participant as unusually sensitive or potentially objectionable in nature.
  • Submits at the time of continuing review proposed changes to the protocol involving:
    • 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 information, human tissues, and biological specimens, as applicable, and the provisions for participants control of such release.
  • Submits the following changes to the protocol on FOR224 Project Revision/Amendment Form for approval of proposed modifications in research 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 information, human tissues, and biological specimens, 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

The Senior Staff at the time of initial or continuing review, or review of modifications to approved research, as applicable:

  • Evaluates the HSP, IPR, or Project Revision Amendment, as applicable, to determine if the required information listed above is sufficient for presentation to the IRB for review:
  • 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 for expedited review at the time of initial or continuing review, or review of modifications of approved research in order to approve research determines that there are adequate provisions 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?

Approved on March 23, 2007 , by:

Ferdinand Urthaler, MD
IR
B Chair

Sheila Deters Moore, CIP
OIRB Director