July 25, 2013 | Volume 3 Issue 3

Institution BulletinLetter from the CEOEvery day seems to bring additional evidence of the need to reform the rules governing IRB review of data repositories. Earlier this month, for example, I attended a panel discussion about PCORNet, a collaboration founded to pursue certain objectives of the Affordable Care Act. The ACA authorized creation of the “Patient-Centered Outcomes Research Institute” (PCORI) to conduct comparative effectiveness research, and PCORI has formed PCORNet to develop national networks of clinical treatment data. Some of the speakers discussed a vision of national-level repositories of electronic clinical treatment data that can be mined for research purposes, but opined this simply “cannot be done” under current IRB and privacy rules.

I think we all can agree that an overhaul of the rules surrounding the collection, storage and use of data is overdue. A PRIM&R workgroup called for reform in 2007, saying “certain provisions of the existing regulations pose significant barriers to research using human specimens and data while offering little additional protection for the individuals from whom the specimens were obtained.”1 SACHRP echoed the call in 2011.2 Many of us are anxiously awaiting the agencies’ next steps after the 2011 ANPRM3 solicited feedback about regulatory revisions affecting repository research.

Without agency action, IRBs are left to struggle through the existing crazy quilt of regulatory provisions and guidance. To help support you and your ethics board, Quorum recently presented a webinar on IRB review of biorepositories that you can find on our website at www.QuorumReview.com/Resources. One of the enclosed articles in this Bulletin looks at the recent HIPAA/HITECH Omnibus Final Rule regarding the “future use” of data; the other article focuses on trends in FDA Warning Letters. Please contact us if we can be of further assistance. We look forward to an opportunity to work with you!

Sincerely,

Cami Gearhart, CEO Quorum Review IRB

1 Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group (March, 2007) at p.1

2 Attachment A to January 24, 2011 SACHRP Letter to the Secretary

3 76 Fed Reg 44512 (July 26, 2011)

1501 Fourth Avenue, Suite 800 | Seattle, Washington 98101 T 206.448.4082 | F 206.448.4193 | QuorumReview.com

April 24, 2014 | Volume 4 Issue 2

July 25, 2013 | Volume 3 Issue 3

Although the HIPAA/HITECH Omnibus Final Rule was effective in March of 2013, the changes relating to research are worth reviewing- particularly if you or your organization is involved with research that proposes to store information for future research. The new HIPAA rule offers flexibility that it is intended to alleviate administrative burdens on researchers and subjects and harmonize with the Common Rule documentation requirements.

Compound Authorizations

Under the previous HIPAA rule - when individuals were asked to take part in a study that had an optional component (for example banking of tissue, or additional pharmacogenomics analysis) - it was not allowable to combine the authorization for the main study and that optional component. Instead individuals should have been presented with two separate authorizations: one for the required part of the study (the “conditioned authorization” and one for the optional parts of the study (the “unconditioned authorization”). This was logistically problematic in that it was confusing and created additional paperwork. It also conflicted with the Common Rule informed consent requirements which allow individuals to consent to all aspects of a study in a single document.

Under the new HIPAA rule, a single authorization can address both required and optional parts of a study as long as there is clear delineation between the “conditioned” and “unconditioned” components of the research, and the subject is given the option to participate in the unconditional activities.

It is important to note that the rule allows covered entities, researchers, and IRBs discretion with respect to the documentation of the decisions related to optional aspects of the research. The consent could have an additional signature line, check-boxes, or initial lines, for example. One option that was explicitly not allowed under the rule is an “opt out” provision, for example: “check this box if you do not want to participate in the sub-study”. HHS explains that this approach does not allow individuals to clearly affirmatively authorize the optional part of the research and could be considered coercive.

Specificity Requirements

Another important change relates to the scope of an authorization. Under the previous HIPAA rule, authorizations were required to be specific and individuals could not authorize unspecified future research using their information. Again, this interpretation conflicted with the Common Rule standards related to consent.

The 2013 Final Rule does not require an authorization to be specific, rather an authorization must include a description of each purpose of the requested use or disclosure in such a way that it would be reasonable to expect the individual should understand that their PHI could be used and disclosed for such future research. As with the change related to compound authorizations, HHS gives discretion to covered entities, researchers, and IRBs as to how to adequately describe future research. Another important note is that HHS indicated covered entities and researchers could rely on IRB-approved consent forms that were obtained prior to the effective date of the final rule — if the consent form reasonably informed an individual about the future research and was combined with a HIPAA-compliant authorization.

These changes offer enhanced efficiencies and facilitation of research initiatives. It is important to ensure that your policies, procedures, and forms reflect these changes to take full advantage of these updates.

Evaluating Your HIPAA Authorization Template and Procedures

April 24, 2014 | Volume 4 Issue 2

July 25, 2013 | Volume 3 Issue 3

In the recent edition of our sister publication, The Quorum Forum, we discussed reflecting on the past year as a means to formulate possible improvements to IRB procedures. A review of FDA warning letters to IRBs from 2013 provides an opportunity

to evaluate your IRB procedures and policies and evaluate them against the regulatory requirements for IRBs. If you are interested in the specifics, FDA warning letters are posted publicly on the FDA website, here.

The handful of warning letters issued to IRBs list several failings that may seem straightforward; however, it is worthwhile to review the issues FDA raised and evaluate your own IRB procedures and policies. This exercise can help to ensure that each of these regulatory requirements is met.

For ease of reference covering the points noted in warning letters, Quorum Review has developed a checklist for your use:

Another important point to consider is whether the study file provides adequate documentation that the above-referenced procedural requirements are followed. Once procedures have been identified that meet the regulatory requirements, it would be prudent to self-audit study files to ensure the documentation in the files clearly records that the IRB is following procedures and fulfilling regulatory obligations.

In addition, to procedural failings, the FDA warning letters addressed a lack of appropriate documentation in IRB minutes. Again, it may be worthwhile to review examples of recent minutes to ensure the following information is documented in minutes appropriately.

For your convenience, Quorum Review has developed a checklist for Board minutes:

To download the Word document formats of these special checklists, please visit our website:

www.QuorumReview.com/institution-bulletin-apr2014-warning-letters

Learning from 2013 Warning Letters to IRBs

April 24, 2014 | Volume 4 Issue 2

July 25, 2013 | Volume 3 Issue 3

New Offerings in 2014 from Quorum Review IRB We are constantly improving our services to better serve you and your Institutional needs

15 Board Meetings per Week

In April 2014, Quorum expanded its Board meeting schedule to include a Monday meeting for new protocols and consent forms, thus giving us a total of 15 meetings per week. This change allowed us to offer an additional North American Board on Fridays - giving us 2 meetings a week for U.S.-Canadian research review. We continue to offer our Cambridge, Massachusetts oncology Board on Tuesday, our two daily meetings (Monday through Friday), as well as our weekly meetings on Wednesday and Thursday.

FREE WEBINAR: May 13 & 15, 2014

On May 13th and May 15th, join Quorum Review for a free webinar on Understanding Reporting Obligations to the IRB. Our own regulatory attorney, Mitchell Parrish, JD, RAC, CIP will be hosting this one-hour live web broadcast which will provide guidance on how and when to report safety findings and unexpected events to your IRB. Sign up below!

Go to www.QuorumReview.com/free-webinar-understanding-reporting-obligations-irb

International Research Review

Quorum Review now offers ethics review for research performed outside of the U.S. and Canada. We can perform according to any of the following criteria:

• Compliance under ICH GCP, local standards, and U.S. standards (if applicable)

• Coordinate with local review committees if they exist

• Serve as the sole IRB of record where no local review committees exist (and is permitted to do so by local standards)

Learn more by visiting us as:

www.QuorumReview.com/International

Contact Quorum ReviewInterested in learning more about Quorum Review? Our Institutional Team is ready to answer your inquiries regarding your organization’s specific institutional IRB needs.

Nancy Jane Earnhardt Institutional Specialist - East nearnhardt@quorumreview.com T| 919-930-5198

Lyndsey Broerman Institutional Specialist - West lbroerman@quorumreview.com

T| 513-417-4234

The Institution Bulletin is a special publication of the Quorum Forum, and brought to you by the Institution Team at Quorum Review IRB.

April 24, 2014 | Volume 4 Issue 2