COMMENTS AND RESPONSES TO QUESTIONS
611 East Wells Street
Milwaukee, WI 53202
414/278-1341 phone
414/276-3349 fax
Elizabeth Dooley, Executive Director
Joseph Glorioso, PhD, President
The document is a great educational tool, however, the Society questions
whether this document is appropriate for inclusion in Appendix M. The
document is over 40 pages in length and the vast majority of the information
is not specific to gene therapy. There is concern regarding timely revisions
if the information is added to the Appendix M. Given the evolving nature
of informed consent, such revisions would be important to maximize compliance
with the relevant regulations. The information provided is a good general
overview provided in a user friendly format.
- provides an understanding of the expectations of the NIH
- useful in keeping us aware of innovative ideas to improve our consent
process
- layout provides a useful tool in introducing and teaching professionals
new to Gene Transfer Research and a good review for current professionals
- the discussion, the tools and background materials, the sample language,
and the list of references will be helpful as an educational tool
- have available both as internet web pages with links and as a downloadable
pdf file
The Society would suggest limiting the additions to Appendix M to areas
specific to gene transfer studies. Even with the disclaimer at the beginning
of the document, addition of samples to the Appendix M would give the
impression of directive. Examples of areas noted that would be helpful
to include in Appendix M include: adding a line referring to financial
conflicts of interest to M-III-A-1, adding a statement indicating that
the gene transfer aspects of the study should be clearly designated in
the consent form to M-III-B, adding a sentence related to study discontinuation
and withdrawal consequences to M-III-B-1-c, and adding risk of cancer
language to M-III-B-1-e.
- have review by FDA: that information provided meets their requirements;
provide links to their specific site that addresses the issue being
discussed
- provide a link of up-dated risks for the various vectors that are
being used and have been reviewed with acceptable/required language
for the ICF at this site under discussion of Appendix M-III-B-1-e or
provide a link such as provided in Sample 2
- under discussion of a Phase I/II Study, pg17, suggestion of using
2 consent forms - may cause problems if a participant consents to one
and not the other. The development of the phase II consent form if separate
would be very difficult without the results of the phase I portion of
the trial.
- discussion of long-term follow-up, who determines the specific follow-up
activities, what activities meet the requirement?
- appreciate their being available alongside the discussion
- encourage addition of more tools to increase the educational value
of the document
There is concern that all samples provided would meet the requirements
of understandability and will be acceptable to the FDA, IBCs and IRBs.
IRBs and IBCs have an ongoing struggle with improving the informed consent
documents. Placing suggested wording in a document like Appendix M could
stifle ongoing attempts to improve the informed consent process.
- appreciate samples, readily available, well worded, 8th grade level,
developed by experts in communication
- helpful and important to have sample language accessible to new researchers
and staff looking for additional resources.
How do you believe your organization's members will receive this guidance?
Well received as an educational tool
What aspects do you think your members will find particularly helpful?
We think the discussion is helpful in providing understanding of what
is expected to investigators as an educational tool.
Would you recommend this guidance to your members?
Yes, as an educational tool
The Society believes that OBA would provide a more useful and relevant
addition to Appendix M by limiting the scope of the information to gene
therapy specific issues. This will have the most impact for all individuals
seeking advice on the important issues of clinical gene transfer.
Clearly, OBA and the RAC subcommittee have been thoughtful and thorough
by drafting a document which could serve as a general resource. Providing
the document on the OBA website would allow this document to be used as
an educational tool.
One very disturbing statement in the current document reads "All
too often, consent is viewed as only obtaining a participant's signature
on a consent form". The Society must disagree most strongly with
this statement. Our members, especially our clinical investigators, and
the IRBs and IBCs which help formulate these documents, take the informed
consent process extremely seriously. Significant efforts and resources
are placed in the development and administration of the informed consent
process. In fact, most investigators appropriately see the verbal process
as the major critical component of the informed consent process.
In summary, the document dilutes the impact a concise summary of gene
therapy related informed consent issues would have on improving the consent
process. The document as written is worth providing as an educational
tool on the OBA website but its attempt to define the complex nature of
the informed consent process falls short and therefore inappropriate for
Appendix M. For the general information about informed consent issues
that make up the bulk of this document, referral to the organizations
with jurisdiction will improve compliance and provide more up-to-date
information.
ASGT thanks you for the opportunity to comment on the proposed addition
to Appendix M. WE hope our comments will be useful in improving the informed
consent process for gene transfer subjects.
The American Society of Gene Therapy is a professional, non-profit medical
and scientific organization dedicated to the understanding of gene therapy
and to promoting professional and public education in this field.
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