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May 28, 2003

Dockets Management Branch (HFA-305)

Docket Number 02N-0475

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

RE: Comments on Docket Number 02N-0475

To whom it may concern:

On behalf of the Applied Research Ethics National Association (ARENA),
we appreciate the opportunity to comment on the Draft "Financial
Relationships and Interests in Research Involving Human Subjects:
Guidance for Human Subject Protection" published in the Federal Register
on March 31, 2003. ARENA is a membership organization for professionals
whose responsibilities include the protection of human and animal
research subjects.  ARENA is a division of Public Responsibility in
Medicine and Research (PRIM&R), and shares with that organization a
commitment to advance the highest ethical standards governing research
and to foster their consistent application.  ARENA's members include
administrators, chairs and members of Institutional Review Boards (IRBs)
and Institutional Animal Care and Use Committees (IACUCs), representing
organizations across the nation with varying volumes and complexities of
research.

ARENA wishes to congratulate DHHS for taking the initiative in
generating this guidance to institutions regarding identification and
management of financial conflict of interest in research involving human
subjects. Overall, ARENA concurs with the substance of the guidance and
believes that it represents an excellent and necessary first step toward
a comprehensive and effective policy.

 

We recognize that institutions, owing to their differing structures,
research mix and goals, are best served by guidance that aids them in
examining the issues. Therefore, ARENA offers the following comments
that we hope will be useful to you in preparing the final guidance
document.

**[COMMENTS ON COMPONENTS OF THE DRAFT GUIDANCE:]{.underline}**

**[Item II. Guidance for Institutions, IRBs and
Investigators]{.underline}**

[II.A. General Approaches to Address Financial Relationships and
Interests in Research Involving Human Subjects]{.underline}

ARENA agrees with the deliberative questions offered in this section of
the draft Guidance. They represent a good first step for an organization
evaluating and assessing its management program.

## II.B. Points for Consideration 

ARENA agrees with the suggested approaches. They provide flexibility to
varying organizational infrastructures in developing effective plans for
managing and/or mitigating the potential negative impact of financial
interests.

[II.C. 1. Specific Issues For Consideration Regarding
Institutions]{.underline}

1\. ARENA would strongly encourage a requirement that institutions
develop a \"COI Management Plan.\" This defined plan would provide some
means for accountability and reflection on oversight performance. The
DHHS guidance could clearly serve as the basis for the contents of the
plan.

2\. ARENA notes that the role of COICs in the guidance is not entirely
clear. The guidance states that COICs are established to \"deal with
individuals\' financial interest in research or verify their absence.\"
The phrase \"deal with\" seems somewhat vague. ARENA presumes that this
means that COICs are responsible for creation of a management plan for
COIs, should that become necessary. It is also unclear who (COICs, IRBs
or other bodies) will be responsible for evaluating the effectiveness of
the management plan.

3\. ARENA concurs with the recommendation to support establishment of
clear communication channels between IRBs and COICs. One possible method
to achieve this goal would be to require IRB representation on COICs.
IRBs and COICs may be able to devise other procedures, including
exchange of minutes or tagging of files.

4\. ARENA concurs with the recommendation for training of \"appropriate
individuals regarding financial interest requirements.\" ARENA would
encourage HHS to expand this recommendation to include training for all
key personnel (defined by NIH as \"individuals who contribute in a
substantive way to the scientific development or execution of the
project\".)

[II.C. 3. Specific Issues For Consideration Regarding IRB
Review]{.underline}

ARENA notes that the decision regarding disclosure to subjects in the
consent form is the IRB's responsibility. ARENA presumes that COICs can
make this recommendation in their management plan. Nonetheless, ARENA
believes IRBs should retain authority to require disclosure even if the
COIC does not recommend this action, or to override the COICs
recommendation for modification of the consent form.

[II.C. 4. Specific Issues For Consideration Regarding
Investigators]{.underline}

ARENA notes that the guidelines to investigators appear vague and
inconsistent. ARENA certainly agrees that investigators should consider
\"whether to take any of the following actions\" with respect to
inclusion of COI information in the consent form. However, ARENA
recommends that the guidance be clear that the ultimate decision whether
or not to disclose information to the potential subject is the
responsibility of the IRB and COIC as discussed above.

More importantly, ARENA recommends that the guidance be revised to add
that, based on the potential effect of a financial relationship, and
irrespective of the recommendations of the COIC, the actions
investigators may consider should also include divesting financial
interests, or absenting themselves from the consent process or from the
conduct of the research itself.

**[SUGGESTIONS FOR INCLUSION IN THE DRAFT DOCUMENT]{.underline}**

ARENA suggests that comments directed to the sponsors of research be
included in the guidance. At a very minimum, there should be a
discussion of the responsibilities commercial sponsors have to
participate in an entity\'s conflict of interest process, particularly
in the area of the disclosure of information about real or potential
conflicts.

**[RECOMMENDATIONS FOR ASSESSING IMPACT OF THIS GUIDANCE]{.underline}**

In keeping with the considerable latitude afforded to institutions and
IRBs in structuring COI policies based on their individual needs and
organizational structure, ARENA believes that there would be benefit in
assessing what specific policies institutions have put in place.
Therefore ARENA encourages organization of a one-day forum on best
practices to take place one year after implementation of these
guidances. ARENA respectfully suggests that this forum could be
organized by DHHS or under the auspices of PRIM&R/ARENA, concurrent with
our annual meeting.

Thank you for the opportunity to share our comments and recommendations.
Members of our Public Policy Committee are available to provide more
specific, detailed information and clarifications to assist you in
finalizing the guidance document.

Sincerely,

![](media/image2.png){width="1.875in" height="0.5979166666666667in"}
![](media/image3.png){width="2.076388888888889in"
height="0.43680555555555556in"}

Bruce Gordon, MD Karen Hansen

Member Co-Chair

ARENA Public Policy ARENA Public Policy

Committee Committee

![](media/image4.jpeg){width="2.770138888888889in"
height="0.32013888888888886in"}

Marianne Elliott

ARENA President

Cc: ARENA Public Policy Committee Contributors:

> Mark Waxman, Melody Sacatos, Mary Adams, Ada Sue Selwitz, Susan
> Kornetsky, Helen McGough, Erica Heath, Molly Greene, Gwenn Oki, Liz
> Bankert