CUMC IRB Investigator Meeting IRB Frequently Asked Questions October 11, 2005

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CUMC IRB Investigator MeetingIRB Frequently
Asked Questions October 11, 2005
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Objectives

• Todays session will provide information on
• Multi-center studies How does funding affect
  review?- Additional considerations when Columbia
  leads the research collaboration
• Engagement in research How is it determined?
• PHS 398 revised human subjects guidelines How do
  they affect grant applications?
• Certificate of Confidentiality When, why, how?

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Frequently Asked Questions IRB
Websitehttp//www.cumc.columbia.edu/dept/irb/
Provides answers to common questions received by
the IRB

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OHRP GuidanceEngagement of Institutions in
Research

• Refer to OHRP Guidance on
  Engagement of Institutions in Research
• Based on definitions of human
  subject research An institution is
• engaged, if its employees
• -interact or intervene with
  individuals, and/or
• -collect private identifiable research
  for research purposes

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OHRP Guidance

• Refer to the guidance, Engagement of
  Institutions in Research, found at
• 
  http//ohrp.osophs.dhhs.gov/humansubjects/guidance
  /local.htm
• Provides guidance on when one is or is not
  engaged in human subjects research.
• -Conducting research vs. providing a service
• -Analysis of data when identifiers are kept by
  any member of the research team

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OHRP Agreements

• Federalwide Assurance (FWA)
• 2) IRB Authorization Agreement (IAA)
• Individual Investigator Agreement (IIA)
• (formerly called the Unaffiliated
  Investigator
• Agreement)

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Submission materials Collaborative research
not conducted under an IRB Authorization Agreement

• For all collaborative projects
• the name and title of the individual (identified
  by role) who is responsible for the conduct of
  the project at the collaborative site(s)
• 2) the procedures that will be conducted at each
  site
• 3) the funding mechanisms involved
• 4) identification of the individual who will
  serve as the overall principal investigator for
  the project
• 5) clear description of what the CU personnel
  will be doing and what will be done at CU.

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Submission materials Collaborative research
not conducted under an IRB Authorization Agreement

• In addition, if CU is the lead institution
• 1) the status of IRB approval at each site
  engaged in the research or arrangements
  previously made or in progress to delegate
  authority for review
• 2) identification of the coordinating centers and
  description of services provided by coordinating
  centers, if applicable

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Submission materials Collaborative research
not conducted under an IRB Authorization Agreement

• In addition, if CU is the lead institution
  (contd)
• 3) a written plan explaining how regulatory
  compliance will be ensured for each site engaged
  in the research. The plan should include
• i) details on how local IRB approval will be
  obtained and maintained at each site
• ii) description of procedures in place to ensure
  that the informed consent document approved by
  the local IRB does not have substantive changes
  in the consent form approved by the CU IRB,
  particularly the purpose, procedures, and risks
  sections
• iii) assurance that unanticipated problems
  involving risks to subjects or others will be
  reported to the local and CU IRBs.

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Submission materials Collaborative research
not conducted under an IRB Authorization Agreement

• In addition, if the research will be federally
  conducted or supported
• 1) the name and Federalwide Assurance (FWA)
  number for each site engaged in the research
• 2) an Individual Investigator Agreement (IIA) for
  any individual who is engaged in the research but
  is not working under the auspices of an
  institution or organization other than CU.