The Institutional newsletter is intended to help institutional clients feel prepared to deal with the day-to-day challenges of research ethics.

1. October 21, 2011 | Volume 1, Issue 3
The Quorum Review: Institutional Edition
Letter from the CEO
As we move quickly into fall, federal regulators continue to keep us busy with new guidances for the research and
ethics 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 policies
on managing conflicts of interest. The new DHHS rule follows suit, refining and clarifying what qualifies as a
financial conflict of interest under DHHS regulations. We include a summary and discussion of the primary
changes 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. The
ANPRM proposal to mandate single IRB review of domestic multi-site studies is particularly provocative. Studies
have shown that centralized IRB review can be efficient and we believe the needs of local institutions can be
addressed during centralized review. The proposals are quite far-reaching, however, so there is something for
everyone to support, to oppose, or to consider. Comments are due on October 26th and we encourage you to
submit via http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html to remind HHS of your
concerns as a research institution.
We are honored to have the privilege to work with you and your research teams.
Sincerely,
Cami
Cami Gearhart, CEO
Quorum Review IRB

2. October 21, 2011 | Volume 1, Issue 3
Proposed Changes to the U.S. research subjects, reduce ambiguities, and adequately
address the changing research environment.
HHS Common Rule and the
Impact on Institutions Proposed Changes
The proposed changes fall into 7 categories (for
Overview categories with extensive changes, see additional
information below):
On July 22, 2011, the U.S. Department of Health
and Human Services (DHHS) announced that the 1. Refinement of the risk-based framework to
DHHS is contemplating various changes to the more accurately calibrate the level of review
regulations overseeing research on human subjects, to the level of the risk (Section II of the
referred 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 Board
The changes can be found in an Advance Notice of for review for all domestic sites of multi-site
Proposed Rulemaking (ANPRM, studies (Section III).
http://www.gpo.gov/fdsys/pkg/FR-2011-07- 3. Improvement of the forms and processes
26/html/2011-18792.htm), Human Subjects Research used for informed consent (Section IV).
Protections: Enhancing Protections for Research Subjects 4. Establishment of mandatory data security
and Reducing Burden, Delay, and Ambiguity for and information protection standards for all
Investigators, published in the July 25 Federal studies that involve identifiable or potentially
Register. This article summarizes the proposed new identifiable data (Section V).
Common Rule changes and discusses those changes 5. Implementation of a systematic approach to
that may significantly impact institutions. the collection and analysis of data on
unanticipated problems and adverse events
across all trials to harmonize the complicated
HHS Rationale array of definitions and reporting
Since the Common Rule was first adopted two requirements, and to make the collection of
decades ago, research methodologies have changed, data more efficient (Section VI).
accompanied by a marked increase in the amount, 6. Extension of Federal regulatory protections
type, and location of research. Studies are conducted to apply to all research, regardless of funding
in a wide range of areas, including national security, source, conducted at U.S. institutions that
traditional biomedical research, social and behavioral receive some Federal funding from a
sciences, economics, education, and the Common Rule agency for research with
environment. The changes are sought by the DHHS human subjects (Section VII).
in order to strengthen protections for human

3. 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 intended
Section II is the most extensive section of the
to simplify and consolidate the required reporting of
ANPRM, 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 data
protections standards for identifiable information
elements that are flexible enough to enable
and rules protecting against the inappropriate re-
customized safety reporting; (2) implementation of a
identification of de-identified information that is
Web-based, Federal-wide portal that allows
collected or generated as part of a research study; (2)
investigators to submit electronically certain safety
revision of the rules for continuing review; (3)
data and have it automatically delivered to
revision 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 all
the list of categories of research that may be reviewed
Federal agencies.
by expedited review and providing for streamlined
submission requirements for review; (4) revision of
the regulations regarding studies currently Proposed Changes Impacting Institutions
considered exempt to expand and add certain In addition to the changes discussed above, Sections
categories, remove certain limitations, and clarify III (titled “Streamlining IRB Review of Multi-Site
that routine review is not required; and (5) Studies”) and VII (titled “Extension of Federal
establishment of required written consent for Regulations”) may have significant impacts on
research 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 all
to consent forms, which includes prescribing what domestic sites in a multi-site study rely upon a single
content must be included and how it must be IRB as their IRB of record for that study. The
presented in consent forms, limiting the length of proposal does not prohibit institutions, for their own
certain sections, and restricting inappropriate purposes, to conduct additional internal ethics
content or institutional boilerplate); (2) review of the review. However, the ANPRM notes that these
criteria for granting a waiver of informed consent or internal reviews would no longer have any regulatory
waiver 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 of
existing data and biospecimens.

4. October 21, 2011 | Volume 1, Issue 3
Section VII requests comments on a proposed Financial Conflicts of Interest
change that would extend the Common Rule to all
research studies conducted at an institution that and Public Health Service
receives some Federal funding for research with Funding: New DHHS Final
human subjects. This change would prevent an
institution from voluntarily deciding to “check the Rule
box” on their Federalwide assurance and to not
apply the Common Rule to specific research that
receives no federal funding. The complexity of relationships in research among
researchers, institutions, industry, and other
stakeholders can lead to potential conflicts of
Guidance for Clients interest. Given the recent scrutiny in this area, many
The Consortium of Independent Review Boards organizations have taken action to strengthen
(CIRB) will submit comments to the ANPRM and policies for managing, reducing, or eliminating
the Association for the Accreditation of Human conflicts of interest.
Research Protection Programs has posted its
comments on its website (www.aahrpp.org).
However, Quorum encourages institutions to review The Department of Health and Human Services
the 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 to
operations and business. Institutions may submit conflicts of interest. The FDA also is expected to
comments 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 final
0005), and click on “Submit a Comment.” The rule and its changes that impact institutions
ANPRM comment period closes Wednesday, receiving federal funding for human subject research
October, 26, 2011. Please feel free to contact and Quorum’s response to the new rule.
Quorum if you have any questions or would like to
discuss 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

5. October 21, 2011 | Volume 1, Issue 3
Prospective Contractors” and is codified at 42 CFR (3) Fewer Disclosure Exclusions – the new
Parts 50 and 94. The rule’s effective date was definition of SFI includes several interests
September 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 are
an institution that revises its financial conflict of now excluded only if the Investigator is
interest policy in compliance with the new rule and employed or otherwise appointed by the
makes its policy publicly available. For those institution. Additionally, income from
institutions 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 or
its internal policy. review panels, is excluded only if sponsored
by or are for a federal, state or local
government agency, an institution of higher
Summary 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

6. 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.