October 21, 2011 | Volume 1, Issue 3The Quorum Review: Institutional EditionLetter from the CEOAs we move quickly into fall, federal regulators continue to keep us busy with new guidances for the research andethics communities. This month, our newsletter tackles two of the most recent guidances for you.In this edition, we include an article on the topic of the new Department of Health and Human Services (DHHS)rule on financial conflicts of interest. In the past few years, many organizations have strengthened their policieson managing conflicts of interest. The new DHHS rule follows suit, refining and clarifying what qualifies as afinancial conflict of interest under DHHS regulations. We include a summary and discussion of the primarychanges contained in the new rule and their possible effects on institutions.Also included in this newsletter is Quorum’s initial analysis of the advanced notice of proposed rulemaking(ANPRM) issued by The Secretary of Health and Human Services pertaining to the Common Rule. TheANPRM proposal to mandate single IRB review of domestic multi-site studies is particularly provocative. Studieshave shown that centralized IRB review can be efficient and we believe the needs of local institutions can beaddressed during centralized review. The proposals are quite far-reaching, however, so there is something foreveryone to support, to oppose, or to consider. Comments are due on October 26th and we encourage you tosubmit via http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html to remind HHS of yourconcerns as a research institution.We are honored to have the privilege to work with you and your research teams.Sincerely,CamiCami Gearhart, CEOQuorum Review IRB
October 21, 2011 | Volume 1, Issue 3Proposed Changes to the U.S. research subjects, reduce ambiguities, and adequately address the changing research environment.HHS Common Rule and theImpact on Institutions Proposed Changes The proposed changes fall into 7 categories (forOverview categories with extensive changes, see additional information below):On July 22, 2011, the U.S. Department of Healthand Human Services (DHHS) announced that the 1. Refinement of the risk-based framework toDHHS is contemplating various changes to the more accurately calibrate the level of reviewregulations overseeing research on human subjects, to the level of the risk (Section II of thereferred to as the Common Rule. The government is ANPRM).currently seeking the public’s input on the changes. 2. Use of a single Institutional Review BoardThe changes can be found in an Advance Notice of for review for all domestic sites of multi-siteProposed Rulemaking (ANPRM, studies (Section III).http://www.gpo.gov/fdsys/pkg/FR-2011-07- 3. Improvement of the forms and processes26/html/2011-18792.htm), Human Subjects Research used for informed consent (Section IV).Protections: Enhancing Protections for Research Subjects 4. Establishment of mandatory data securityand Reducing Burden, Delay, and Ambiguity for and information protection standards for allInvestigators, published in the July 25 Federal studies that involve identifiable or potentiallyRegister. This article summarizes the proposed new identifiable data (Section V).Common Rule changes and discusses those changes 5. Implementation of a systematic approach tothat may significantly impact institutions. the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicatedHHS Rationale array of definitions and reportingSince the Common Rule was first adopted two requirements, and to make the collection ofdecades ago, research methodologies have changed, data more efficient (Section VI).accompanied by a marked increase in the amount, 6. Extension of Federal regulatory protectionstype, and location of research. Studies are conducted to apply to all research, regardless of fundingin a wide range of areas, including national security, source, conducted at U.S. institutions thattraditional biomedical research, social and behavioral receive some Federal funding from asciences, economics, education, and the Common Rule agency for research withenvironment. The changes are sought by the DHHS human subjects (Section VII).in order to strengthen protections for human
October 21, 2011 | Volume 1, Issue 3 7. Improvement in the harmonization of regulations and related agency guidance Section VI seeks to improve the current system for (Section VIII). the real-time prompt collection of adverse events or unanticipated problems. The changes are intendedSection II is the most extensive section of the to simplify and consolidate the required reporting ofANPRM, covering 5 main sections: (1) establishment safety information. The proposed changes include:of mandatory data security and information (1) use of a standardized, streamlined set of dataprotections standards for identifiable information elements that are flexible enough to enableand rules protecting against the inappropriate re- customized safety reporting; (2) implementation of aidentification of de-identified information that is Web-based, Federal-wide portal that allowscollected or generated as part of a research study; (2) investigators to submit electronically certain safetyrevision of the rules for continuing review; (3) data and have it automatically delivered torevision of the regulations regarding expedited appropriate agencies and oversight bodies; and (3)review to provide for mandatory regular updating of harmonization of safety reporting guidance across allthe list of categories of research that may be reviewed Federal agencies.by expedited review and providing for streamlinedsubmission requirements for review; (4) revision ofthe regulations regarding studies currently Proposed Changes Impacting Institutionsconsidered exempt to expand and add certain In addition to the changes discussed above, Sectionscategories, remove certain limitations, and clarify III (titled “Streamlining IRB Review of Multi-Sitethat routine review is not required; and (5) Studies”) and VII (titled “Extension of Federalestablishment of required written consent for Regulations”) may have significant impacts onresearch use of any biospecimens collected for institutions.clinical purposes. Section III requests comments on the feasibility,Section IV covers 3 main sections: (1) improvement advantages, and disadvantages of mandating that allto consent forms, which includes prescribing what domestic sites in a multi-site study rely upon a singlecontent must be included and how it must be IRB as their IRB of record for that study. Thepresented in consent forms, limiting the length of proposal does not prohibit institutions, for their owncertain sections, and restricting inappropriate purposes, to conduct additional internal ethicscontent or institutional boilerplate); (2) review of the review. However, the ANPRM notes that thesecriteria for granting a waiver of informed consent or internal reviews would no longer have any regulatorywaiver of documentation of informed consent; and status in terms of compliance with the Common(3) proposed changes to strengthen the consent Rule.protections related to reuse or additional analysis ofexisting data and biospecimens.
October 21, 2011 | Volume 1, Issue 3Section VII requests comments on a proposed Financial Conflicts of Interestchange that would extend the Common Rule to allresearch studies conducted at an institution that and Public Health Servicereceives some Federal funding for research with Funding: New DHHS Finalhuman subjects. This change would prevent aninstitution from voluntarily deciding to “check the Rulebox” on their Federalwide assurance and to notapply the Common Rule to specific research thatreceives no federal funding. The complexity of relationships in research among researchers, institutions, industry, and other stakeholders can lead to potential conflicts ofGuidance for Clients interest. Given the recent scrutiny in this area, manyThe Consortium of Independent Review Boards organizations have taken action to strengthen(CIRB) will submit comments to the ANPRM and policies for managing, reducing, or eliminatingthe Association for the Accreditation of Human conflicts of interest.Research Protection Programs has posted itscomments on its website (www.aahrpp.org).However, Quorum encourages institutions to review The Department of Health and Human Servicesthe ANPRM and submit either general comments or (DHHS) and Food and Drug Administration (FDA)comments to specific questions referenced in the also have rules addressing such conflicts. Notably,ANPRM in light of an institution’s current the DHHS recently issued a new final rule related tooperations and business. Institutions may submit conflicts of interest. The FDA also is expected tocomments by visiting http://www.regulations.gov, change its conflict of interest rule in the near future.enter the following ID number (HHS-OPHS-2011- The focus of this article is on the new DHHS final0005), and click on “Submit a Comment.” The rule and its changes that impact institutionsANPRM comment period closes Wednesday, receiving federal funding for human subject researchOctober, 26, 2011. Please feel free to contact and Quorum’s response to the new rule.Quorum if you have any questions or would like todiscuss the ANPRM. The New Final Rule The DHHS issued its new final rule on August 25, 2011, which amends the 1995 DHHS financial conflict of interest regulations. The new rule is titled, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible
October 21, 2011 | Volume 1, Issue 3Prospective Contractors” and is codified at 42 CFR (3) Fewer Disclosure Exclusions – the newParts 50 and 94. The rule’s effective date was definition of SFI includes several interestsSeptember 26, 2011 and full compliance is required that were previously excluded. For example,no later than August 24, 2012 or immediately upon salaries, royalties and other remuneration arean institution that revises its financial conflict of now excluded only if the Investigator isinterest policy in compliance with the new rule and employed or otherwise appointed by themakes its policy publicly available. For those institution. Additionally, income frominstitutions with more stringent policies than what seminars, lectures and teaching engagements,the new rule requires, the institution must adhere to or from service on advisory committees orits internal policy. review panels, is excluded only if sponsored by or are for a federal, state or local government agency, an institution of higherSummary of Changes that Impact Institutions education, research institute that is affiliated with an institution of higher education, an (1) Decreased Monetary Threshold for academic teaching hospital or medical center. “Significant Financial Interests” (SFI) - the prior (1995) regulation had a de minimis (4) Broader Definition of “Investigator” – threshold of $10,000 for disclosure that investigator is now defined as the Project generally applied to payments or equity Director/Principal Investigator, as well as any interests. Under the new rule, the threshold other person, regardless of title or position, was lowered to $5,000, which generally who is responsible for the design, conduct or applies to payments for services and/or reporting of research funded by the Public equity interests (including any equity interest Health Service (PHS). in non-publicly traded entities). (5) New definitions of “Key Personnel” and (2) Increased Scope of Disclosure – the revised “Senior/Key Personnel” – these terms are a definition of SFI requires Investigators to subset of the term “Investigator” and for disclose all SFIs that reasonably appear to be individuals that fit these definitions a grantee related to an Investigator’s “institutional organization must provide access on a responsibilities,” as so defined by the publicly available website to certain institution. This expands the scope of information pertaining to their disclosed required disclosures beyond those directly financial conflicts of interest. related to the research study itself. (6) Increased Reporting Requirements – the new rule adds more information that an
October 21, 2011 | Volume 1, Issue 3 institution must report when there is a (10) Retrospective Review Requirements – “financial conflict of interest” (FCOI), which Each institution is required to conduct a is defined as an SFI that could directly and retrospective review in those cases of non- significantly affect the design, conduct or compliance with the regulation. The reporting of PHS-funded research. This institution is not required to report the information includes the name of the entity review to the PHS awarding component with which the investigator has a FCOI; the unless bias is found. If bias is found, the nature and value of the FCOI; a description report must address the impact of the bias on of how the interest relates to the PHS-funded the research project and the actions the research and the basis for the institution’s institution has taken, or will take, to determination that the financial interest eliminate the effect of the bias. conflicts with such research; and key elements of the institution’s management Quorum’s Response to the New Final Rule plan. Quorum’s current conflict of interest policy is largely(7) Public Accessibility Requirements – in compliance with the new final rule, so Quorum institutions must now make certain FCOIs does not expect to make significant modifications. available on a publicly accessibly website However, Quorum will lower its SFI threshold for maintained by the grantee organization. federally funded studies from $10,000 to $5,000 and accordingly will modify its Site Information(8) Management Policy – each institution must Questionnaire that all sites are required to submit as maintain a current, written, enforced policy well as Quorum’s Conflict of Interest Discloser form. on financial conflicts of interest and make the policy publicly available via a publicly Revisions to Quorum’s internal conflict of interest accessible website or by a written response to policy and corresponding forms will occur prior to any requestor within five business days of the August 2012 compliance date. For those such request. institutions revising their conflict of interest policy consistent with the new final rule and publishing(9) FCOI Training – each investigator must this policy prior to August 2012, Quorum will apply complete training prior to engaging in the standards and requirements contained in the research related to any PHS-funded grant or new rule. contract and must update this training at least every four years. If there are any questions regarding the new DHHS conflict of interest final rule, please know that Quorum’s Regulatory Department is always available to answer any questions.