|
Regulations Affecting Clinical Research, Including HIPAA
A. The Regulatory Framework Within Which WIRB Functions
WIRB is registered with FDA/OHRP. WIRB’s IRB registration number is IRB00000533,
and WIRB’s parent organization number is IORG0000432.
WIRB reviews many types of human subject research, including clinical research,
behavioral research, and epidemiological research, in the United States and internationally.
WIRB reviews research in accordance with three primary standards, as well as other
regulatory standards, when appropriate:
The FDA regulations apply to clinical investigations conducted on medical products
under FDA jurisdiction that will be marketed in the United States, principally drugs,
devices and biologics.
The HHS regulations apply to research that is funded by HHS and other agencies that
have adopted "the Common Rule," represented at 45 CFR 46, Subpart A. Institutions
that receive federal funding for research must obtain an "assurance," a formal agreement with the government in which
the institution promises to take prescribed steps for the protection of human subjects.
Usually, the assurance will be a FederalWide Assurance (FWA) from the Office for
Human Research Protections (OHRP). However, for some research other types of assurances
may be used. Please call WIRB's Client Services at 1-800-562-4789 if you have questions
about obtaining an assurance, or consult the
OHRP web site.
The International Conference on Harmonization (ICH) is an international standard
for drug approval that has been adopted as either law or guidance in many countries
(EU, Canada, Japan and the United States). In the United States, FDA has adopted
it as guidance. ICH is similar to the FDA drug and IRB regulations, but has a few
stricter standards.
WIRB has established written procedures that ensure that research approved by WIRB
meets all these three primary standards. However, WIRB may vary from the requirements
of one of the three standards when it is not applicable. For instance, we will allow
the investigator to vary from the ICH requirement that the subject receive a signed
consent form for an HHS-regulated behavioral interview study conducted in a setting
where a signed copy of the consent form represents an unacceptable risk of breach
of confidentiality for the subject.
In addition, WIRB reviews research funded by the Department of Defense, the Department
of Education and other federal agencies, as well as research that will be submitted
to the Environmental Protection Agency.
B. HIPAA
WIRB also provides some services under the Privacy Rule (45 CFR Parts 160 and 164) of the Health Insurance Portability
and Accountability Act of 1996 (HIPAA). WIRB will review requests for
waivers of authorization and partial waivers
of authorization for covered entities upon request (WIRB forms for requesting
review of partial and full waivers of authorization are available on the Download
Forms page of www.wirb.com). WIRB will also review authorization language upon the
request of a covered entity. If the authorization language is embedded in the research
consent document, then the IRB must review it. If the authorization language is
separate from the research consent document, then the covered entity may determine
whether or not to submit the language for IRB review. WIRB will review separate
authorization documents upon request.
Click here to view the white paper
discussion on HIPAA, written by Cynthia M. Gates, R.N., J.D., C.I.P.
C. Expedited Review
WIRB does not use the expedited review process for the review of initial research.
All initial review of research, even for those categories of research which fit
the expedited categories, are reviewed at a convened meeting. WIRB does use the
expedited review process for changes in research. In accordance with FDA guidance
in the September 1998 Information Sheets, entitled "Continuing Review After Study Approval," WIRB reviews only
minor changes in research through expedited review.
WIRB also ensures that changes in research that are approved through the expedited
review process meet the OHRP standard of not materially changing the risk/benefit
ratio (OPRR
Institutional Review Board Guidebook, 1993).
back to top of page
|