and specimens not originally collected for the research (HHS, 2008). Regulatory requirements for waiver of consent under the Common Rule are set forth in 45 CFR 46.116(d) and are as follows18:

(1)  the research involves no more than minimal risk to the subjects;

(2)  the waiver or alteration of consent 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.

HIPAA (HHS, 2007) allows waiver or alteration of the requirement of authorization for the use of PHI in research when an IRB or privacy board determines that

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:

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

b.  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).

c.  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.

Some study protocols may require recontact and reconsent of sources. The determination of whether and under what conditions this is necessary should be made by the JPC’s IRB based on factors including the level of identifiers requested and the sensitivity of the research question being asked.

Acceptable uses of materials for research may be broader when consent is documented. The terms of the consent, if available, must be carefully

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18As of early 2012.



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