IRB Documentation

Welcome to your online meeting space as multi-site collaborators with our lead site, The Goldring Center for Culinary Medicine at Tulane University (GCCM), for the cohort study, Cooking for Health Optimization with Patients (CHOP)! After you review the below documents and have any questions or concerns, please feel free to contact the Lead PI.

 

STUDY STAFF

 

STUDY RESOURCES

  • Institutional Review Board (IRB) summary: All partner sites regardless of the requirements of your own site’s IRB/IRB equivalent MUST contact it to complete your Authorization Agreement and send it along with your current (<4 years from completion]) CITI Group 1 Biomedical Basic Course completion certificate of your site’s PI to the Lead PI at the lead site of Tulane University. This allows revision of our Lead IRB package for review and continuing oversight by the Tulane Biomedical IRB. Also, this Agreement MAY SAVE YOU SIGNIFICANT TIME AS YOU MAY NOT BE REQUIRED to submit your separate package to your local IRB/IRB equivalent if it confirms you can defer review and continuing oversight of research subject protection to the Tulane IRB. If you must submit your separate package to your IRB/IRB equivalent, below are documents from the current lead package that you can adopt as templates to fit your needs (i.e. if you are only participating in one of the four CHOP sub-studies such as the medical student study, CHOP-Medical Professionals, then you can delete any information in your package that does not relate to the medical students.
  • IRB documents for CHOP Lead IRB package documents: Approval Letter, Application Core (Part I, Part II), Authorization Agreement, CITI certificate (of Lead PI if you need an example, and/or if your IRB/IRB equivalent requires this document and inclusion of the Lead PI on your own separate package with your IRB/IRB equivalent), Consents/Assents (Adult Community, Ages 7-11 Community & Employee, Ages 12-17 Community & Employee, Adult Employee, Adult RCT), Surveys (Medical Professionals/Trainees, Children 7-17 yo Community & Employee, Adults Community, Employee, RCT), Recruitment Resources (Script Community, Employee, RCT;  Email Recruitment Medical Professionals/Trainees, Community, Employee, RCT), Protocol, and Medical Record Release (your IRB/IRB equivalent should you be required to submit a separate package will require you to complete its own PHI and HIPAA forms) PHI Release Community, Employee, RCT; HIPAA Authorization Community, Employee, RCT).
  • Legal summary: Your partner site may require you to have documentation of a data sharing agreement. This is included in your License Agreement you signed with GCCM. It specifies that you retain ownership of any data generated by your site, but share the data with GCCM at Tulane. The Lead PI will provide you your own site’s data in a CSV file upon request but cannot release the data from other sites. The data otherwise is kept securely on the Qualtrics server as per the above IRB-specified details.
  • Data collection: Please send the survey link to your site’s subjects, [1] typically at the beginning of the fall semester and end of the spring semester to the full school, and [2-4] typically at the first and last classes for your treatment group: [1] Medical professionals and trainees (this test link lets you explore an earlier survey version), [2] community (children 7-17 years old and adults), [3] employee (children 7-17 years old and adults), and [4] chronic disease RCT (adults).
  • Data analysis: Contact the Lead PI for (a) individual-site analysis, specifying your request, intended journal/conference and category, and deadline four weeks before results are required; and (b) collaborative-site analysis, specifying your request for aggregate analyses across all sites.
  • Manuscript preparation: The Lead PI strives to generate a paper with aggregate data at least annually, preferably at the end of each fall and spring semester. To increase your publications and thus hopefully your institutional support and grant funding, two co-authors are welcomed from each site for each aggregate paper. If you seek to publish a paper or submit a conference abstract with just your site’s data, please include at least the Lead PI and Executive Director as co-authors to strengthen quality from insights learned across all the sites. Please include GCCM Publications in your cited references to increase the impact of you and your CHOP Co-Investigator’s work.