July 25, 2013 | Volume 3 Issue 3

Institution BulletinLetter from the CEO

Sincerely,

Cami Gearhart, CEO Quorum Review IRB

It is discouraging to read recent news reports of alleged research misconduct by individuals in China, including the failure to disclose the results of preclinical anaimal studies. The allegations bring to mind other cases of misconduct. The claim that the MMR vaccine can cause autism spectrum disorders, for example, was described in a 2011 journal article as “the most damaging medical hoax of the last 100 years.”

“Science is at once the most questioning and . . . skeptical of activities and also the most trusting,” said Arnold Relman, former editor of the New England Journal of Medicine. “It is intensely skeptical about the possibility of error, but totally trusting about the possibility of fraud.”

Scientifc misconduct is relatively infrequent, and the tools of the IRB are limited. That being said, IRB members and staff must remember to be vigilant for the “red flags” of misconduct and fraud. These red flags include the absence of preclinical data, data that appears “too perfect” and, of course, complaints by research participants or staff.

We realize the resources needed to support an effective human research protection program can be daunting. Enclosed are two articles to assist your institution in its mission to protect research participants. One article describes conflicting FDA guidance on exculpatory language and the other discusses IRB review of new technological “eConsent” tools.

Quorum Review is honored to have the privilege to work with you and your research teams. Please let us know if we can be of further assistance.

1601 Fifth Avenue, Suite 1000 | Seattle, Washington 98101 T 206.448.4082 | F 206.448.4193 | QuorumReview.com

July 25, 2013 | Volume 3 Issue 3

One of the responsibilities of an IRB is to ensure that the information given to subjects during the consent process is not “exculpatory.”1 Guidance issued in 1996 provides examples of “exculpatory” and “acceptable” language for consent forms.2 Two examples of “exculpatory” language regarding samples are provided below.

Examples of “Exculpatory” Language Regarding Samples

“I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items.”

“By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.”

Although the guidance provides no analysis, it implies that subjects have an ownership interest in samples that are provided for research, and that a statement in the consent form waiving those rights would be considered exculpatory.

1 21 CFR 50.20; 45 CFR 46.116

2 “Exculpatory Language” in Informed Consent, Office for Protection from Research Risks (OPRR), Cooperative Oncology Group Chairpersons Meeting, November 15, 1996, available at: http://www.hhs.gov/ohrp/policy/exculp.html.

In 2011, the Food and Drug Administration (FDA) and OHRP released a draft guidance providing a conflicting interpretation.3

The draft guidance indicates that the agencies determined that “language…is not exculpatory if it informs subjects that, by agreeing to allow the use of their biospecimens for research purposes, they are giving up any legal right to be compensated for the use…” The draft guidance argues that such language is not exculpatory because there is no law or policy explicitly recognizing a legal right to compensation for specimens.4 Given this, the agencies conclude the statements noted above are now acceptable.

Although the 2011 draft guidance has not been finalized, it is important for IRBs to carefully review consent language regarding specimens. As the draft guidance notes, in practice, researchers and sponsors do not compensate subjects for the use of samples or any commercial developments. Subjects should have a clear expectation about what will happen with

3 Guidance on Exculpatory Language in Informed Consent, DRAFT, Office for Human Research Protections, Food and Drug Administration, August 19, 2011,available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM271036.pdf (Emphasis added).

4 The draft guidance indicates the agencies are unaware of any federal or state law or policies that suggest research subjects would have any legal right to compensation if they voluntarily sign an informed consent form which clearly states they will not be compensated for providing their biospecimens.

Consent Forms: Exculpatory Language and Subject Samples

1 One

2 Two

July 25, 2013 | Volume 3 Issue 3

their samples and the risks associated with the sample collection and use. Several points to address in the consent form are provided below.

Points to Address in the Consent Form � The samples that will be taken (consider

including type, amount, and collection procedure)

� The coding or de-identification procedures for the samples

� A realistic discussion of privacy protections and risks5

� The use of the samples for this research and future research or, if it is unknown, whether future research may be conducted with the samples

� The length of time samples will be stored

� Whether samples can be withdrawn or destroyed at the request of the subject and if so, the process for making such a request

� The plans for or possibility of commercial development and the ownership of such developments

5 Given that identification of individuals is possible with limited data and publicly available information it is important to avoid guarantees of absolute privacy. See, Melyissa Gymrek, et. al., “Identifying Personal Genomes by Surname Inference.” Science, 2013; 339 (6117) 321-324. See also Kolata, Gina, “Poking Holes in Genetic Privacy.” New York Times [New York] 13 Jun. 2013. Web. 26 Jun. 2013. Available at: http://www.nytimes.com/2013/06/18/science/poking-holes-in-the-privacy-of-dna.html?src=rechp&_r=0.

When Performance Matters

Choose Quorum Review

Working with Institutions to Achieve Great Things

Quorum Review personalizes the IRB approach for your specific research studies with customized coversheets and model consent forms that utilize language preferences. We understand and recognize your needs and we are here to facilitate your research process.

• Streamlined process

• Unbiased results

• Regulatory leadership

• Experienced Board

• Personalized Account Manager

• OnQ online document portal

• Diverse training options

• Fast turnaround times

• Phase I-IV review

• Customized approach

Learn more about Quorum’s customized processes for the ethics review of institutional research at:

www.quorumreview.com/institutions

July 25, 2013 | Volume 3 Issue 3

eConsent in Clinical Research: Planning and Questions for the IRB

With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation.

In June, Quorum Review released a new information sheet on eConsent in Clinical Research. The following is taken from the document. You can download the full information sheet at www.quorumreview.com.

Considerations When Planning eConsent Implementation

When considering the use of eConsent processes and systems in clinical research, early planning and close coordination is important. A carefully

planned implementation process involves choosing the eConsent approach that works best for the study, the sites and the patients involved, and working closely with the IRB to understand the review processes for using eConsent, including how the eConsent system may impact IRB review and steps involved in meeting documentation requirements.

To have a smooth IRB review, talk to the IRB about review and documentation requirements for eConsent and the IRB’s background in reviewing eConsent materials and documentation.

Questions to Consider When Talking to the IRB � Has the IRB reviewed eConsent previously?

� What additional documents or forms does the IRB require to review eConsent?

� What additional information does the IRB require to review eConsent?

� How will the IRB review the eConsent?

� What file requirements (format and size) does the IRB have?

� What are the expected timelines for review of the eConsent? Will it take longer than the review of a paper consent?

� Does the IRB have any specific restrictions or requirements related to eConsent that we should be aware of?

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 nearnhardt@quorumreview.com T| 919-930-5198

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