Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 33, No. 11, November, 2018

Back Issues

Here’s an inside look at what you will receive in the digital newsletter, including actual excerpts.

HIPAA Exemption

IRBs and Use of “HIPAA Exemption” … p. 4
IRBs and New “Broad Consent” Option … p. 5
Human Subjects and Acceptance of Data … p. 6

IRBs and Pregnant Research Subjects … p. 7
IRBs and Subject Risks in IVD Studies … p. 7
In Congress … p. 8
FDA Warning … p. 9
OHRP Determination … p. 10
In Court: Wade v. Oregon Health Science University … p. 11
In Agencies & Organizations … p. 12
Compliance Conferences & Courses … p. 14

IRBs and Recommendations on Use of “HIPAA Exemption” – Pt. 3 … p. 4

We continue here with one of the dozens of new human subject protections regulations in the revised Common Rule, set to go into effect on January 21, 2019. Our present focus is on an exemption to the requirement for informed consent of the research subject due to the “HIPAA Exemption.”

We last covered this topic in our April HRR (p. 7). We resume by noting that the HIPAA Privacy Rule usually requires researchers to obtain informed consent for the use of a subject’s “protected health information” (PHI) or have the subject’s authorization waived or altered by an IRB or a Privacy Board.

The explanation of this waiver is provided by the Secretary’s Advisory Committee on Human Research Protections (SACHRP). As we concluded our April HRR article, we began coverage of the three criteria for approving a consent waiver or alteration with a brief portion of the first criterion. We now present that initial brief portion, and complete it as follows.

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IRBs and the New “Broad Consent” Concept – Pt. 3 … p. 5

We continue here with the “broad consent” feature that represents one of the many changes to human subject protections contained in the revised Common Rule. The new Common Rule – to become effective on January 21, 2019 – has quite specific descriptions of how and when to use broad consent. Our coverage focuses on the advice for IRBs/researchers on broad consent as described by the Secretary’s Advisory Committee on Human Research Protections (SACHRP).

The relevant SACHRP’s advice appears as “Attachment C – Recommendations for Broad Consent Guidance.” This attachment, in turn, is one of six attachments on different human subject protection aspects of the Common Rule that were submitted to the Department of Health and Human Services (or HHS). Attachment C is on the Web at https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-c-august-2-2017/index.html.

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Human Subject Protection and Acceptance of Clinical Data – Pt. 4 … p. 6

As we have covered in recent HRRs, the FDA’s new regulations on what kinds of data will be accepted as part of various medical device submissions will become effective in February of 2019 (e.g., see the September HRR, p. 6). These regulations apply both to data generated by studies in the U.S. as well as studies conducted abroad.

In this article we focus on a question that FDA received when it first proposed the new regulations; namely, what about multicenter studies that are conducted both inside and outside of the U.S.? This comment:

“… noted that the proposed rule identified different requirements for acceptability of results from clinical investigations depending on the locale of the study, that is, inside or outside the United States. The comment indicated applying this differential regimen would be difficult when a multicenter clinical investigation has sites both inside and outside the United States” (83 Fed. Reg. 7366-7388 at p. 7370, February 21).

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