IRB Monthly Investigator Meeting

Columbia University Medical Center IRB

October 11, 2005

Objective

Explain recent changes in the NIH PHS 398 Human Subjects Research Supplement and how they affect grant applications

Describe how, when, and why Certificates of Confidentiality may be obtained

Changes to PHS 398 form

– Further address “How can you determine whether research that involves only the use of specimens and/or data from pathology archives or a specimen band and/or data repository is human subjects research?” (4/26/05)

– Address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens (12/30/04 and 1/20/05)

– http://grants.nih.gov/grants/funding/phs398/phs398.html

Background for changes• OHRP Guidance on Research Involving Coded Private Information or Biological Specimens (8/10/04)

– http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf

• NIH Notice NOT-OD-04-069 (9/17/04): OHRP Guidance would not be implemented until 1/10/04 receipt date for applications

– http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-069.html

• NIH Notice NOT-OD-05-020 (12/30/04): OHRP Guidance to be followed; PHS 398 revised to clarify definitions and application of guidance

– http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-020.html

OHRP Guidance (8/10/04)– (1) Provides guidance as to when research involving coded private information

or specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46).

– (2) Reaffirms OHRP policy (see OHRP guidance on repository activities and research on human embryonic stem cells) that, under certain limited conditions, research involving only coded private information or specimens is not human subjects research.

– (3) Clarifies the distinction between (a) research involving coded private information or specimens that does not involve human subjects and (b) human subjects research that is exempt from the requirements of the HHS regulations.

– (4) References pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens.

NIH definition: Clinical researchDefined in the PHS 398 Definitions and the Grants Policy Statement Glossary –

Patient-oriented research.  Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.  Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. 

Patient-oriented research includes:

a.  Mechanisms of human disease, b.  Therapeutic interventions, c.  Clinical trials, or d.  Development of new technologies.

Epidemiologic and behavioral studies

Outcomes research and health services research

NOTE:  Studies that meet the criteria for Exemption 4 are not considered clinical research for purposes of this definition

NIH OER Websitehttp://grants.nih.gov/grants/policy/hs/specimens.htm

NIH Human Subjects Research Decision Charthttp://grants.nih.gov/grants/policy/hs/PrivateInfoOrBioSpecimensDecisionChart.pdf

NIH FAQs for Reviewershttp://grants.nih.gov/grants/policy/hs/faqs_specimens.htm

NIH FAQs for Applicantshttp://grants.nih.gov/grants/policy/hs/faqs_applicants.htm

Effect on funding process

• Preparation of submission to IRB

•Application of federal regulations for the protection of human subjects in research in grant application

• Determination that does not reflect new guidance may delay in NIH review process and notice of award

• Recent NIH contact with IRB to modify human subject research determinations

Certificate of Confidentiality (COC)• Issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure;

• Allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level;

• May be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.

• By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to participants.

NIH COC Kioskhttp://grants1.nih.gov/grants/policy/coc/index.htm

IRB Process

• Review protocol with intent to obtain COC

• Ensure consent form has COC language (available in RASCAL)

• Approve protocol contingent upon COC being obtained

– Consent form not released

• Sign off on application for COC

• Review modification when COC is approved and submitted to IRB

• Release consent form

Questions?

Contact IRB Office with any questions regarding:

– Determination of whether a project involves human subjects research

– Certificate of Confidentiality