Appendix D

Procedure and Guidelines for Site Authorization

1. Applicability: This procedure defines the standards and parameters for obtaining site authorization to conduct research.
2. Considerations for Site Permission: The Principal Investigator (PI) must determine what site permissions are needed, the process for securing site permission and whether permission is likely. In addition, the PI must secure IRB approval from each research site if the respective site has its own IRB. Special consideration is required for data collection at prisons, VA hospitals, military bases, or international sites. Such sites may require additional time, reviews and approval processes.
3. Procedure Statement: The Office of Academic Research requires site authorization for all on- and off-campus research protocols involving human subjects. The (PI) must ask for an authorization/cooperation letter from each site or entity that agrees to allow the research to take place at that location. The authorization letter must be on file with the Institutional Review Board (IRB) before any activity is conducted at that site.
4. Procedure:
   
   1. The letter of request for site authorization must specify each of the following:
      1. authorization to contact potential participants
      2. authorization to recruit potential participants
      3. authorization to collect data.
   2. The letter of request for site authorization must:
      1. Be professionally written, grammatically correct, with no typographical errors.
      2. Be specific, stating the name of the Principle Investigator, co-investigators, the title of the proposed study, and affiliation with Grand Canyon University.
      3. Include a brief summary of the proposed study to confirm understanding of the study, including the purpose, research questions under investigation, and significance of the research.
      4. Describe the nature of the data collection, and what is required by the site for the investigator to collect data including any restrictions or limitations.
      5. Describe what responsibilities, if any, the site is assuming (example - will the site allow employees to use work time to fill out surveys, the site will provide on-site location for the research, will the site give access to files, etc.).
      6. Include a statement that the investigator will provide a copy of the IRB-approved, and stamped consent document to the site or individual authorizing the site for the research.
      7. Include the time frame (if any) involved in completing the research.
      8. Describe any benefits to the site/company.
      9. Have a signature line with printed name, title and date of signature.
   3. In addition to a letter of request for site approval, the PI should provide the site or entity with a copy of the research prospectus or full proposal.
   4. The PI may want to provide a sample authorization/cooperation letter to the site or entity so that all permission letters are complete with the required authorization(s) and site information.
      1. The site authorization/cooperation letter must be on department letterhead and include the title and signature of the faculty member or department head who gives the authorization.
      2. The letter should include the investigator’s name and title, the title of the research protocol, and a brief summary of the protocol to confirm their understanding of the study. Include a statement that the site will receive a copy of the IRB-approved, stamped consent document. The letter should define each of the following, if applicable: a) Authorization to contact potential participants. (the instructor/dept. might provide contact information.), b) Authorization to recruit potential participants, and, c) Authorization to collect data.
      3. The letter should also state what the site has agreed to allow the investigator to do, including any restrictions or limitations and what responsibilities, if any, the site is assuming. State whether the investigator will provide a copy of aggregate results.
      4. Sample authorization letters and templates are available in the DC Network under
         Research/Dissertation > Institutional Review Board > Guidelines for Obtaining Site Authorization
   5. The IRB research application can be submitted to IRBNet with all authorization letters having been received, however at least one authorization letter must be included in the protocol. After IRB approval, all letters must be submitted to the Office of Research in IRBNet before research can be initiated at those locations.