Title: CUMC IRB Investigator Meeting IRB Frequently Asked Questions October 11, 2005
1CUMC IRB Investigator MeetingIRB Frequently
Asked Questions October 11, 2005
2Objectives
- 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?
3Frequently Asked Questions IRB
Websitehttp//www.cumc.columbia.edu/dept/irb/
Provides answers to common questions received by
the IRB
4OHRP 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
5OHRP 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
6OHRP Agreements
- Federalwide Assurance (FWA)
- 2) IRB Authorization Agreement (IAA)
- Individual Investigator Agreement (IIA)
- (formerly called the Unaffiliated
Investigator - Agreement)
7Submission 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.
8Submission 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
9Submission 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.
10Submission 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.