July 25, 2013 | Volume 3 Issue 3

Institution BulletinLetter from the CEO

Sincerely,

Cami Gearhart, CEOQuorum Review IRB

This spring will mark the fifth anniversary of the downfall of Coast IRB. In March 2009, it was announced that Coast IRB had fallen for a sting operation. Congress and the Government Accountability Office had sent several IRB’s a sham medical device study for review. The study proposal had several flaws, including no device description, no preclinical data, questionable procedures and outdated investigator licensure documentation. Coast IRB’s board approved the study unanimously. Within weeks of disclosure of the sham, the FDA issued a warning letter and Coast chose to close its doors.

Many in the ethics community were not surprised. Coast IRB had never been accredited and had received a disturbing FDA Warning Letter the prior year. Disillusioned employees had been seeking work elsewhere.

Nevertheless, it’s worthwhile to take steps to ensure that your IRB – or the IRB to which you outsource – does not make this type of mistake. Factors to consider in assessing the strength of an IRB include accreditation status; quality of the IRB members; availability of regulatory support during Board meetings; documented separation of business interests and ethics review; and the organization’s commitment to quality assurance and compliance measures.

Quorum Review is committed to the highest standards in all these areas. When an institution is ready to use a central IRB, we are committed to supporting the institution with a high quality review, a strong regulatory team and multiple quality control and compliance processes. And to help support you and your ethics board, today’s newsletter describes new guidelines from SACHRP as well as Quorum’s ability to support international research. We look forward to an opportunity to work with you.

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

February 11, 2014 | Volume 4 Issue 1

July 25, 2013 | Volume 3 Issue 3

International Ethics Review: Now Available From Quorum Review IRB

Over the last decade, clinical researchers have expanded their use

of study sites located outside of North America. While this shift has increased participant availability in the clinical trials pipeline, it has also exposed research protocols to redundancy and delays arising from multiple ethics review requirements and multiple service providers.

Quorum’s Commitment to InternationalIn response, Quorum Review IRB has delivered on our strategic commitment to develop the expertise and processes needed to meet the research industry’s demand for international and domestic ethics reviews. As a result, sponsors, CROs, and institutions can now access Quorum’s industry leading ethics review or consulting services even when protocols employ study sites across the globe.

Quorum’s strategic investment in international capabilities builds on more than 20 years of experience conducting ethics reviews in North America. Already boasting one of the industry’s largest team of regulatory attorneys, Quorum has bolstered this expertise with extensive research on international laws and policies governing participant ethics reviews. In addition, Quorum has crafted submission requirements that ensure qualifying international protocol submissions can benefit from the same standard turnaround times available to North American studies.

What kinds of international ethics reviews are available to Quorum’s clients?Quorum’s expertise gives us the flexibility to provide ethics reviews in one of three ways, depending on the client’s individual needs and requirements under local law:

Ethics reviews based solely on United States standards.

Hybrid ethics reviews in which both United States and country-specific standards are considered.

Ethics reviews based solely on country-specific requirements. Typically, this form of review is only available when the country-specific standards are the same or more protective than U.S. Common Rule.

Learn more at:

QuorumReview.com/International

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February 11, 2014 | Volume 4 Issue 1

July 25, 2013 | Volume 3 Issue 3

In March of this year, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) developed recommendations related to Internet research1. The Committee acknowledged that the human subject protection regulations, written over thirty years ago, are inadequate in the context of Internet research. In eighteen pages, the Committee attempts to address some of the dilemmas faced in online research and provides practical guidance for IRBs and researchers

in this space.

While the entire document is a worthwhile read, the SACHRP Committee’s recommendations addressed three particular concerns related to consent and Internet research that

are worth noting, including: (1) verifying identification; (2) ensuring comprehension; and (3) obtaining appropriate documentation when needed.

Identity Verification and Parental Permission

The Committee begins by explaining that adequate identity verification may be handled through vendors or software, or in some cases, such as minimal risk research,

1 Id., Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations.

may not be a critical issue. The recommendations point out that the federal Children’s Online Privacy and Protection Act (COPPA) mandates parental permission if subjects under the age of 13 are being recruited and they provide identifiable information2. Ultimately, the Committee recommends that researchers and IRBs need to be aware that identity verification is a major issue online. IRBs are provided with some points of consideration when determining whether a given identity verification approach is adequate:

The importance to the research. That is, are there eligibility criteria? Is there likelihood of repeat or fraudulent participation, whether for mischief or to collect multiple payments?

The level of risk to subjects. Low-risk surveys where parental consent could be waived may require only minimal identity verification, perhaps a checkbox. High-risk studies involving the transmission of sensitive information may warrant multiple-factor authentication, such as passwords delivered by mail or telephone, or via an identity verification software or vendor.

There may be a third-party policy or terms of agreement in place that the researcher should acknowledge when considering identity confirmation. For example, Facebook® has a “real-name” only policy, so anonymity

2 See http://answers.hhs.gov/ohrp/questions/7249.

SACHRP Guidelines on Internet Research: Practical Considerations for Online Consent

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is not possible. The norms and expectations of users and venues must be considered.

Subject Comprehension

The SACHRP recommendations include a number of options for confirming subject understanding in the

context of Internet research. In choosing a particular option, the Committee advises that comprehension checks should be designed in the context of the research.

Consent typically consists of a consent form or other document that provides information for the subject’s reference and documents the initial consent interaction, yet the intent remains that informed consent is an ongoing exchange of information between the investigator and subject. For lower risk research, the Committee suggests that a checkbox indicating the user “understands and agrees” may be appropriate. However, for higher risk or more complex research, a greater level of documentation, such as quizzes to check comprehension, may be appropriate. The Committee specifies that however the consent process is conducted, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis.3

Appropriate Determination of ConsentDocumentation of consent is the third major issue addressed in relation to consent for Internet research. Depending on the nature of the research, it may be appropriate to waive or alter some elements of consent in an online setting and include a statement that the subject is agreeing

3 SACHRP, Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, Final Document, approved at SACHRP meeting March 12-13, 2013, available at: http://www.hhs.gov/ohrp/sachrp/mtgings/2013%20March%20Mtg/internet_research.pdf

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.

• 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

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to participate in the research when completing the survey. Consent for a higher risk study may involve a combination of online and in-person interactions, including a Skype® or LifeChat® discussion with the PI, comprehension quizzes, and emailing or mailing the consent form for a signature (either traditional or e-signature) from the subject.

With regard to the validity of electronic signatures, in the United States, the ESIGN law authorizes signatures in certain contexts. OHRP has provided guidance that an IRB can allow such technology “as long as the IRB has considered applicable issues such as how the electronic signature is being created, if the signature can be shown to be legitimate, and if the consent or permission document can be produced in hard copy for review by the potential subject.”4

SACHRP does not advocate for a more stringent review of Internet research; however, the Committee does recognize a need for heightened awareness of subjects’ privacy, confidentiality, and identities and places the responsibility on the investigator for good data stewardship. All parties have an interest in ensuring Internet research meets regulatory requirements. Researchers and IRBs will need to approach online consent with flexibility and creativity and consider consent approaches that will be effective in the context of a given project.

4 Citing, http://www.coppa.org/comply.htm; also see FTC’s August 1, 2012 proposed changes to COPPA, including changes to the COPPA definition of “personal information” to include persistent identifiers (Ropes & Gray, 2012).

2014 Congressional Appropriations Bill: The Effects on ResearchUnder the auspices of bipartisanship, the U.S. Congress and President Barack Obama passed the 2014 Omnibus Appropriations Bill in mid-January to fund the U.S. government through September 30. Here are some of the increases in funding that were included in the bill:

The Food and Drug Administration (FDA) - $217 million above 2013’s fiscal year amount – as well as expansions for other government agencies responsible for researcher research

The Department of Defense saw surges in its medical research programs including $200 million for the Peer-Reviewed Medical Research Program, $125 million for Traumatic Brain Injury and Psychological Health studies, and $120 million for breast cancer research

The National Institutes of Health (NIH) obtained a $1 billion increase over its 2013’s fiscal year allotment (albeit this is below the pre-Sequester 2012 budget level).

Another highlight of the bill is the expansion of public access to a larger portion of Federally-funded research – a mandate to which only the NIH was previously bound. Under the new provision, any research budgeted at $100 million or more would have to be made available to the public online within 1 year of being published in a peer-reviewed journal.

Iowa’s Senator Tom Harkin (D) was a key player in getting the original NIH access put into law. The

February 11, 2014 | Volume 4 Issue 1

July 25, 2013 | Volume 3 Issue 3

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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 EarnhardtInstitutional Specialist - Eastnearnhardt@quorumreview.comT| 919-930-5198

Lyndsey BroermanInstitutional Specialist - Westlbroerman@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.

Senator told the Washington Post, “Expanding this policy to public health and education research is a step toward a more transparent government and better science.”

Despite the bill’s escalation of funding - which will allow current programs to continue and permit approximately 385 new research studies - many in the investigative field criticized the amount as being insufficient, especially since the 2013 sequester gutted many competitive research grants and forced deep staffing cuts. Many believe that government-funded research remains a crucial part of the drug and device development industry. For example, NIH endowments routinely provide funding for those types of research considered too risky or unconventional for private investors.

You can read the Detailed Omnibus Summary by click here.

Upcoming EventsiiBIG’s Clinical Study Teamwork ConferenceRaleigh-Durham, NC April 10-11, 2014

Join Quorum Review’s Mitchell Parrish, JD, RIC, CIP as he moderates an intriguing breakout session covering Proxy Consent—Children and the Cognitively Impaired.

February 11, 2014 | Volume 4 Issue 1