IRB placemats give quick look at federal rules

HCA shares its tool with others

IRB “cheat sheet” placemats provide IRB members with clear regulatory information for reference during IRB review meetings.

The idea is to give board members a simple tool that defines human subjects protection rules and terms. Since the printed material is right at their place at the table, they are more likely to refer to it than they might if it was in a book or in an electronic application, says David Vulcano, LCSW, MBA, CIP, RAC, AVP & responsible executive, clinical research, clinical research group, Hospital Corporation of America (HCA) in Nashville.

HCA printed 14 different placemats for each IRB. The topics refer to regulatory material that is most relevant to the institution’s research mission, as well as some general research regulatory material that often poses problems during IRB discussions.

For instance, IRB members sometimes confuse the various waivers, so one placemat lists three different waivers and their criteria: the waiver of elements of informed consent, the waiver of documentation of informed consent, and the waiver of HIPAA authorization.

“I wanted to lump those three categories together because a lot of IRBs don’t appreciate the difference between the waiver of consent and the waiver of documentation of consent,” Vulcano explains. “I put the waiver of HIPAA authorization on there, too, because when an investigator comes in and says he wants to waive consent, the subsequent question in the IRB’s mind would be that they also have this HIPAA authorization and will the investigator want to waive that as well?”

Vulcano has shared the placemats with other IRBs upon request and offers this sample of the waiver placemat as an example of their content:

Waiver of some or all of elements of informed consent

1. No more than minimal risk* to the subjects;

2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;

3. The research could not practicably be carried out without the waiver or alteration; and

4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Waiver of documentation of informed consent

1. The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

2. The research presents no more than minimal risk* of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

Waiver of HIPAA authorization

1. The use or disclosure of the PHI involves no more than minimal risk* to the privacy of individuals based on, at least, the presence of the following elements:

i. An adequate plan to protect health information identifiers from improper use and disclosure.

ii. An adequate plan to destroy identifiers at the earliest opportunity consistent with conduct of the research (absent a health or research justification for retaining them or a legal requirement to do so) and

iii. Adequate written assurances that the PHI will not be reused or disclosed to (shared with) any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of the PHI would be permitted under the Privacy Rule.

2. The research could not practicably be conducted without the waiver or alteration.

3. The research could not practicably be conducted without access to and use of the PHI.

4. Required documentation of IRB approval of waiver: The IRB must provide the principal investigator specific documentation of its approval of a HIPAA waiver. The documentation must include:

i. The name of the IRB or privacy board (not the names of individual members of the board);

ii. The date on which the waiver was approved;

iii. The signature of the IRB or privacy board chair, or other member designated by the chair;

iv. A statement that the IRB or privacy board has determined that the waiver satisfies the required criteria;

v. A brief description of the PHI that the IRB or privacy board has determined is necessary for research purposes; and

v. A statement that the waiver has been reviewed and approved under either normal or expedited review procedures and that all applicable procedures were followed.

* “Minimal risk” means the probability and magnitude of harm or discomforts anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests of healthy individuals.