November 14, 2018
The Common Rule News – November 14, 2018
Issue 9: Exempt Research, Part 3 of 3
HSD’s Common Rule Webpage
Exempt Research, Part 3 of 3
What types of secondary research can be granted exempt status?
How is this different for the current versus revised Common Rule?
The last two issues of this newsletter – October 31, and November 7 – described what it means for a study to be exempt, the advantages of exempt status, and the changes coming for most of the categories of exempt research.
The October 10th issue described the emphasis placed on secondary research in the revised Common Rule.
Exempt and Secondary Tied Together
This issue draws these two threads together by describing the three categories of exempt research described in the revised Common Rule which are available exclusively for secondary research.
Revised Exempt Category 4: Introduction
Secondary research uses of identifiable private information or identifiable specimens for which consent is not required.
We are providing more details about this category than for other categories because of the high campus interest in this topic, the tremendous growth of secondary research, the complexity of the criteria for this category, and the interaction of this category with Washington State laws.
Exempt Category 4: Criteria
- Secondary research, meaning the use of information and biospecimens collected from subjects through some other activity. There is no interaction with the subjects.
- Consent is not required to obtain and/or use the information or biospecimens. This means: (a) there are no other laws that require consent (or a waiver of consent) for the use; and (b) during the original collection of the information or biospecimens, the individuals (if asked) agreed to secondary uses consistent with the proposed research.
- One or more of these must be true about the information or biospecimens:
- Publicly available
- Not identifiable as recorded by the research team
- Consists solely of identifiable Protected Health Information
- Generated or collected by a federal agency
Exempt Category 4: Interaction with Washington State Laws
Unfortunately, two Washington State laws mean that the UW IRB will not be able to grant exempt status to research that consists of using UW PHI – that is, records or specimens from UW Medicine, the School of Dentistry, School of Pharmacy, and any other component of the UW HIPAA-covered entity. The two laws require consent, authorization, or an IRB-granted waiver for the use of any PHI held in Washington State. HSD is looking into ways to reconcile these regulatory conflicts. For now: medical record reviews will not be exempt.
Exempt Category 4: An Improvement, Nonetheless
The current category 4 description contains the word existing, meaning that the exempt research is limited to the use of information and biospecimens that exist at the time the exempt request is submitted to HSD. The revised category 4 no longer has this limitation. In other words, the secondary use of prospectively-gathered information and biospecimens may qualify for this category of exemption. Bottom line: More studies in this category will be exempt, despite the inability to take advantage of the PHI option.
NEW Exempt Category 7 and Category 8
These new categories focus on secondary research for which subjects have provided broad consent (see Word of the Week, below) for secondary use of their information or biospecimens. Category 7 is for creating and maintaining a repository or database for secondary research. Category 8 is for secondary research use that draws upon those repositories or databases.
The UW IRB will not grant exempt status in these categories during the calendar year 2019, after which we will reconsider these options. Many peer institutions have similar policies. Why?
- The criteria are numerous and complex.
- There is no federal guidance about the new concept of broad consent.
- It is not clear how these categories provide any advantage for researchers.
Word of the Week
Broad consent is a new concept introduced by the revised Common Rule. It means consent specifically provided for the storage, maintenance, and/or use of identifiable information or biospecimens for secondary research. The broad consent process must include most of the standard elements of consent plus several additional elements. These are described in the revised WORKSHEET: Exempt Determination (release date: end of November).
Question from Campus
Q. I read in one of your newsletters about the new requirement for clinical trials to post an unsigned copy of the study consent form in a public database like ClinicalTrials.gov. Why couldn’t I find anything about this at the ClinicalTrials.gov website?
A. The federal agency that manages the ClinicalTrials.gov website is still developing the instructions and informational materials about this requirement. No timeline for release has been provided. However, it is unlikely you will need to post your consent form before mid-2019 because:
- This affects only clinical trials that are approved on or after January 21, 2019.
- The consent form should not be posted until the trial closes to recruitment.
Summary of Changes
HSD’s Common Rule webpage has a summary of the changes. Each issue of this special newsletter will focus on one of these changes – providing in-depth details about how it will affect researchers, the IRB review process, consent forms, application forms, and the Zipline e-IRB system. It will also link to any resources that are available to help with the change. The schedule of topics and newsletter dates are posted on the HSD Common Rule webpage.
Issue 10: November 28, 2018
Focus: Review of Grant Applications
Back issues available on the HSD Common Rule webpage