Mark Barnes gave a seminar on August 2, 2004 on Secondary
Uses of Biologic Materials and Medical Data by Researchers and Commercial
Research Sponsors. Here are my notes taken at that seminar.
There are a broad range of regulations and agreements that
apply to secondary uses:
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Any contract you might sign with a commercial sponsor of
the research.
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The Health Insurance Portability and Accountability Act (HIPAA)
places criminal sanctions on researchers who disclose protected health
information to the wrong people.
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The Common Rule (45 CFR Part 46) applies to any research
conducted by an institution receiving funding from the NIH if that
institution has signed a FWA.
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FDA regulations
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Voluntary accreditation standards for IRBs
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State laws and litigation
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International Committee of Medical Journal Editors ICMJE
standards
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Industry standards (PhRMA)
Be careful because state laws often have something to say
about HIV testing, mental health records, and genetic testing. These state laws
will often apply above and beyond any federal laws.
But you are also constrained by your own ethical concerns.
Some of the legal constraints in health care do not apply
to a commercial sponsor. If they are free to disclose information or use it in
ways that you would not consider appropriate, you place yourself and your
instituation in a very difficult position. Before you give your data to a
commercial sponsor, you should impose contractual constraints on commercial
sponsors to limit their use of data/tissue?
Can there be informed consent to future uses? The are two
extremes on this issue:
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Subjects cannot agree to a future research project about
which they have not been, and cannot be, informed.
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Subjects should be permitted to "donate" their own
data/materials for future uses.
You need to disclose the operation of the data/tissue
repository, the specific types of research to be conducted, the conditions
under which the data/specimens will be released to investigators, and
procedures put in place to protect the privacy of the data/specimens.
The IRB will ask what constitutes a new or different study?
There are both patient privacy concerns and property rights
concerns.
Do subjects have the right to revoke their consent to
future uses? Note that if the data has been de-identified, then it is
effectively impossible to remove the data.
NCI informed consent allows patients to check yes or no to
three questions (see web link).
Commercialization of data/materials
Sometimes universities and companies can make money by
patenting and licensing technologies derived from tissues. Even data alone
might have commercial value. Asking a research subject to waive their
commercial rights is exculpatory language, which is forbidden in the federal
regulations. There have been several examples of litigation over
commercialization of research products.
Greenberg v. Miami Children's Hospital. Miami
Children's applied for a patent on some work derived from research performed by
volunteers. Some of these volunteers were upset because they freely sacrificed
their time and endured many inconveniences, risks, and discomforts. They did
this because they wanted to help other patients with disease and not to enrich
Miami Children's Hospital. The court held that failure to gain consent of
patients on Canavan's disease on the commercialization of research products
represented unjust enrichment.
Washington University v. Catalona. Bill Catalona
wanted to take specimens and information from patients he recruited while
working at Washington University when he left for Northwestern University. He
sent a letter to all his patients (without clearing it first with Washington
University) asking them to sign a consent statement allowing him to keep their
tissues and to continue treating them.
Tilousi v. Arizona State University. Members of the
Havasupai Indian tribe donated blood samples that were taken during a diabetes
study and later used them without permission and without adequate IRB oversight
in unrelated studies of schizophrenia, inbreeding, and theories regarding the
migration of humans to North America, resulting in 23 scholarly papers and 15
publications.
HIPAA requires compound authorization.
Most Clinical Trial Agreements protect the proprietary
information from the company but do not impose a requirement in return on the
company to protect confidential information from the patients. If your informed
consent promises privacy and confidentiality, and you do not seek restrictions
in the CTA, then you are misrepresenting
De-identification removes the right of revocation and
prevents tracing.
Data/materials collected during standard of care
potentially falls under a different standard.
It's more important than ever to have clear and
understandable informed consent forms because if you are sued, it will be
scrutinized by a judge and/or jury with a typical lay person's understanding of
the issues.
If you store records of your own practice in a separate
location, then be careful. Even if you do nothing "researchy" with the data
right away, you should submit a general databanking protocol to the IRB with
continuing review every year. The protocol would describe how you will store
the records, what information will be stored, and what security measures you
will implement to insure privacy. You should specify in braod terms how you
think the data will be used, though you might not know enough to specify the
proposed research in any great detail. Perhaps more important would be to state
the things that you would NOT do.
Hold, store, catalog, replenishing, You will need
prospective consent. Security and privacy protections. Before you do launch a
specific study, you promise or pledge to come back to the IRB for approval
first.
The consent form would explain the purpose of the databank,
what the risks are, and describe the categories of future use.
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I agree to the use of my data for the study of this
disease.
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I agree to the use of my data for the study of all
diseases.
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I agree to be recontacted at a later data to provide
further information.
Tissue banking has to acknowledge the possibility of
genetic testing, which has a different set of professional and legal standards.
It will probably be an expedited review. Then when you
decide later to use these records for research, you would submit another
protocol to the IRB describing the proposed use.
Further questions (August 3, 2004)
How does an IRB handle adverse event reports (AE)? A
committee of FDA and OHRP is working on consistency of reporting of AEs.
Committee has to do "triage" on AE reports. The full IRB would only review
serious AEs that are related to the drug/device. Especially critical is a
review of any AEs that are not mentioned in the informed consent form.
Registry studies can raise some serious ethical concerns.
Registry studies represent surveillance after approval of a device/drug. One
important justification is to monitor for side effects, something that is
always difficult to do well during the efficacy testing of the drug. Sometimes
though, these databases are used for marketing rather than research. Be
cautious of studies of an uncertain or unlimited duration. Make sure that the
the registry does indeed serve a reasonable scientific purpose? You need a
promise to never use the data for marketing purposes and that company will
never contact your patients directly.
This webpage was written
and was last modified on
2008-07-14.
dot edu or click on the email link at the top of the
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Category: Privacy concerns
