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Comments to FDA on Proposed Rule on Informed Consent Elements – 2/25/10

25 February 2010

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Docket No. FDA–2009–N–0592, 29 December 2009, “Informed Consent Elements” Proposed Rule.

Via electronic submission:

Dear FDA Dockets Manager:

AABB is an international association dedicated to advancing transfusion medicine and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 60 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.

AABB appreciates this opportunity to comment on the “Informed Consent Elements” proposed rule published 29 December 2009. The comments submitted on behalf of AABB members are provided in the following format:

Section – language from the proposed rule reprinted with identifying information.

Recommendation – recommendation with rationale.

Proposed New Section – 21 CFR 50.25 Elements of informed consent.

(a) (9) For applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement, notifying the subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act: Information, that does not include personally identifiable information, concerning this clinical trial has been or will be submitted, at the appropriate and required time, to the government operated clinical trial registry data bank, which contains registration, results, and other information about registered clinical trials. This data bank can be accessed by you and the general public at Federal law requires clinical trial information for certain clinical trials to be submitted to the data bank.

Recommendation - AABB strongly recommends that the informed consent documents and processes for certain clinical investigations – screening assays and confirmatory/supplemental tests for blood and HCT/P donors – NOT be required to include a statement that clinical trial information for such investigations has been or will be submitted for inclusion in the clinical trial registry databank.

Rationale – AABB Standards require that a donor’s consent to donate be obtained before donation. AABB Standards and the Code of Federal Regulations require that an allogeneic donor’s eligibility to donate be determined prior to donation. The process commonly used for determining eligibility encompasses required reading of donor education material focused on donor health and potential risk exposure issues (including those dictated by FDA requirements related to HIV and hepatitis), and completion of a questionnaire that currently contains 48 capture questions, with follow-on questioning for affirmative responses. Facility staff are trained in the areas for which eligibility must be determined so they can answer questions the donor may pose, thereby assisting the donor in the informed consent process regarding blood donation.

Establishments involved in collection of products from blood and HCT/P donors, as well as those that perform infectious disease testing, historically have supported manufacturers of donor screening assays by participating in the IND (investigative new drugs) protocols for IVDs (in vitro diagnostics) under investigative protocols. This support is necessary for several reasons.

  1. Increasingly in the past few years, AABB, and its members, have been concerned about the dwindling number of manufacturers showing an interest in producing licensed donor screening tests and supplemental / confirmatory tests for use in the US market. As an example, despite a requirement to test all allogeneic blood and certain HCT/P donors for antibodies to HTLV-I and HTLV-II, currently there is only one manufacturer marketing a test in the US for this purpose. There is no supplemental / confirmatory test available for HTLV-I /II, nor are reliable supplemental / confirmatory tests available for other required tests, such as HIV-1/2.
  2. Blood establishments are required to counsel deferred donors concerning the significance of required screening test results (that is the basis for their deferral) without the benefit of supplemental/confirmatory results.
  3. Other infectious agents, for which there are no licensed screening tests, are currently the cause of transfusion transmitted disease in the United States (Babesia, dengue).

Despite the need to support manufacturers that show interest in donor screening assays, in recent years increasing numbers of establishments have decided to no longer participate in the INDs. The process has become overly burdensome due to the requirements of the separate informed consent that is required by the IND protocol and many establishments believe that this new process will distract donors from focusing on the questionnaire that determines the donor’s eligibility to donate. The separate informed consent process required by IND protocols in recent years has also resulted in complex recordkeeping systems that threaten the establishment’s ability to maintain compliance with good manufacturing practices and some establishments have concluded that they can no longer participate in the INDs.

A requirement that will add even more information to this form will only create additional distractions from the process of determining the donor’s eligibility to provide a safe product for transfusion / infusion to a hospital patient. It is our understanding that the donor will not be able to access any data or descriptions via that will inform the donor of information relevant to his or her own health or participation in the investigation. On the other hand, the blood or HCT/P establishment does counsel donors with reactive / positive test results (according to the investigative protocol approved by FDA), thereby providing relevant and meaningful information to the donor. Therefore, in these particular clinical investigations, the IND protocol will provide better protection to the clinical trial participant than the existence of the clinical trial registry.

Furthermore, the requirements of this proposal are especially onerous as the clinical trial registry databank is an additional area about which the facility’s staff must become informed, and stay informed, in order to respond to questions from the donor. This is a very large undertaking for blood and HCT/P establishments and would likely lead to additional establishments concluding that participation in the INDs is no longer feasible. AABB is concerned that, without a broad representation of establishments participating in the investigations, the results of such investigations may ultimately be skewed.

We restate our recommendation that the informed consent documents and processes for certain clinical investigations – screening assays and confirmatory/supplemental tests for blood and HCT/P donors – NOT be required to include a statement that clinical trial information for such investigations has been or will be submitted for inclusion in the clinical trial registry databank.

In addition, AABB supports the comments submitted to this docket by the American Red Cross and by America’s Blood Centers.

AABB strongly supports initiatives that improve the safety of patients and donors and stands ready to interact with FDA as necessary. Questions concerning these comments may be directed to M. Allene Carr-Greer, Director, Regulatory Affairs,


M. Allene Carr-Greer, MT(ASCP)SBB
Director, Regulatory Affairs