July 21, 2005Page 2 Objectives Today’s 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?
July 21, 2005Page 3 Frequently Asked Questions IRB Website: http://www.cumc.columbia.edu/dept/irb/ Provides answers to common questions received by the IRB http://www.cumc.columbia.edu/dept/irb/
July 21, 2005Page 4 OHRP Guidance “Engagement 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
July 21, 2005Page 5 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
July 21, 2005Page 6 OHRP Agreements 1)Federalwide Assurance (FWA) 2)IRB Authorization Agreement (IAA) 3)Individual Investigator Agreement (IIA) (formerly called the Unaffiliated Investigator Agreement)
July 21, 2005Page 7 Submission materials: Collaborative research not conducted under an IRB Authorization Agreement For all collaborative projects: 1)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.
July 21, 2005Page 8 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;
July 21, 2005Page 9 Submission materials: Collaborative research not conducted under an IRB Authorization Agreement In addition, if CU is the lead institution (cont’d): 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.
July 21, 2005Page 10 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.