COGR COUNCIL ON GOVERNMENTAL RELATIONS

an organization of research universiti 1200 New York Avenue, N.W., Suite
320, Washington, D.C. 20005 (202) 289-6655/(202) 289-6698 (FAX)

# BOARD OF DIRECTORS

CHRISTOPHER MC CRUDDEN

CHAIR

Princeton University

JANET ACKERMAN

Yale University

MARK BRENNER

WNIndiana University (IUPUI)

JERRY BRIDGES

The Johns Hopkins University

PETER DUNN

Purdue University

CARLA FISHMAN

Tulane University

JILDA DIEHL GARTON

Georgia Institute of Technology

ERICA H. KROPP

University of Maryland

JOSEPH MULLINIX

University of California System

ANDREW NEIGHBOUR

University of California, Los Angeles

ANDREW B. RUDCZYNSKI

University of Pennsylvania

JAMES SEVERSON

Cornell University

MARY ELLEN SHERIDAN

University of Chicago

ALICE A. TANGREDI-HANNON

Thomas Jefferson University

DOUGLAS K. TRUE

University of Iowa

V'ELLA WARREN

University of Washington

JANE YOUNGERS

University of Texas Health Science

Center at San Antonio

# 

# KATHARINA PHILLIPS

President

Food and Drag Administration

Institutional Review Boards: Registration Requirements

Docket No. 2004N-0242

Page 2

more appropriate for the FDA to ask the simple question, does the IRB
review protocols dealing with FDA-regulated products, including clinical
investigations supporting research or marketing permits, or not. This
type of question will reduce the reporting burden while still helping to
identify those institutions involved in FDA regulated research
activities. The FDA request for the approximate number of active
protocols involving FDA regulated products reviewed in the preceding
calendar year suggests that the number of FDA protocols being reviewed
is a reasonable basis for determining a IRBs activity level. Protocols
are neither uniform nor uniformly complex. For example, twenty-four
investigational new drug clinical trials will most likely generate a
significantly greater volume of work than five hundred social or
statistical data analyses for marketing permits. Because FDA
appropriately limits its request for protocol data to studies regulated
by the FDA, this limited data set further undermines the value of the
proposed data collection for assessing IRB activity level. Any use of
these data beyond simple identification would be inappropriate.

The additional request for general or generic descriptions of the types
of FDA-regulated products, e.g., drugs, biological products, etc., is
appropriate only if it is used for the purpose of sending useful and
targeted information. The requirement should be limited to a simple
generic description without numerical ranges associated with a specific
product type.

Finally, the names of accredited institutions and organizations are
available from the accrediting bodies. If FDA believes that it is useful
to know which organizations and institutions have been accredited, it
may contact these accrediting bodies directly or review the lists
provided online at the organizations' web sites. Since this information
is publicly available, the additional reporting burden -- no matter how
small -- should not be passed on to the institution. In fact, the
websites will present more up-to-date information than the HHS database
because changes in accreditation status would be reported during the
three-year registration renewal process. In response to the question
posed in the notice, we do not believe that the accreditation status of
an institution considered individually or collectively will provide FDA
with new information that will prove useful in assessing the value of
that accreditation.

We note the effort by FDA and the Office for Human Research Protections
(OHRP) to create a single HHS site for IRB registration. This
simplification and streamlining for IRB registration is much
appreciated.

We note that because FDA regulations require sponsors and investigators
to comply with part 56 or use an IRB that complies with part 56, the FDA
proposes to consider sponsors and investigators to be in compliance with
their regulatory obligations if, and only if, they use a registered IRB.
This approach is sufficient to require the use of registered IRBs. Any
additional sanctions or administrative mechanisms will only serve to
increase the burden on sponsors, investigators, and IRBs without adding
to the protection of subjects.

Food and Drag Administration

Institutional Review Boards: Registration Requirements

Docket No. 2004N-0242

Page 3

In summary, we strongly recommend that prior to finalizing the proposed
rules on IRB Registration Requirements, FDA revise the proposed § 56.106
(b)(3) to a simple, yes/no question and eliminate the request for
accreditation information in proposed § 56.106 (b) (5). Collecting data
for the purposes of identifying IRBs reviewing FDA regulated products
has limited value and must be used within those limits. Any additional
data collections increase the burden on the reporting organizations
without measurably adding to the protection of human subjects. It drains
resources at research institutions and at FDA that we believe should be
directed at activities that will better protect human research subjects.

We appreciate the opportunity to comment.

Sincerely,

Katharina Phillips

President