College of Coastal Georgia Institutional Review Board INTER-INSTITUTIONAL RESEARCH/RECIPROCAL IRB REVIEW POLICY College of Coastal Georgia Institutional Review Board (CCGA IRB) may grant reciprocal IRB approval to Principal Investigators when a research project involves multiple institutions when deemed appropriate to protect human participants in accordance with 45 CFR part 46 and in accordance with the policy and procedures and policy below. Research with Human Participants involving two or more institutions may include research investigations that recruit participants from multiple campuses, involve investigators from multiple institutions, and utilize resources from multiple institutions. All research conducted with human research participants on the campuses of the College of Coastal Georgia and under the auspices of the College MUST be officially approved by an IRB of an institution holding a Federal Wide Assurance (FWA). The criteria below should help investigators to determine which portion of the policy is most applicable. Inter-Institutional/Reciprocal Research Criteria and Policy: 1. If a CCGA faculty member (or staff) is a Secondary Investigator (SI) collaborating with faculty from another institution and no recruitment initiates from, no consent is obtained from, and no data will be collected on the CCGA campus or from its students, faculty or staff, the CCGA faculty member must: • Submit a cover letter to the CCGA IRB • Submit a copy of an official IRB approval from the FWA holding institution to the CCGA IRB. • CCGA IRB will keep this document on record until notified by the CCGA faculty member that the investigation is complete. 2. If a CCGA faculty member (or staff) is a Principal (PI) or Secondary Investigator (SI) collaborating with faculty from another institution, and is involved in recruitment from, obtaining consent from, and collecting data from human participants, the CCGA faculty member must: Submit an Application for Review of Research with Human Participants Submit all other materials requested with the Application form Submit Certification of CITI training and IRB 101 training to IRB Note: if this research is for a Master’s or Dissertation Thesis, the CCGA faculty member may submit a copy of IRB approval from the degree granting institution in addition to the materials above. However, the CCGA IRB will grant reciprocal approval if the research is approved by the degree granting institution. The CCGA IRB will not approve an application that has been disapproved by another FWA holding institution. 3. If a CCGA faculty member (or staff) is a Secondary Investigator (SI) collaborating with faculty from another institution, and is involved in recruitment from, obtaining consent from, and collecting data from students, faculty or staff of the other institution, the CCGA faculty member must: Submit an Application for Review of Research with Human Participants Submit all materials requested with the Application form Submit Certification of CITI training, and IRB 101 training to IRB Or 1 Rev. 1 October 2014 Submit a letter of IRB approval from a FWA holding institution that lists the CCGA faculty member as a secondary investigator, includes evidence of CITI or equivalent ethical training, and specifies the duration and type of approval (in place of the CCGA IRB Application for Review of Research with Human Participants). 4. If a CCGA faculty member (or staff) is the Principal Investigator (PI) and is collaborating with faculty from another institution, and is involved in recruitment, obtaining consent from, or collection of data, the CCGA faculty member will: Apply to the CCGA IRB with the Application for Approval of Research with Human Participants and all the required accompanying materials. The faculty member should provide copies of any reciprocal approval or independent approval from all other institutions involved in the research to the CCGA IRB with the application for review with the application The CCGA IRB will review the application according to standard procedure. Note however, that CCGA IRB approval does not bind another institution, does not confer the institution’s IRB approval, nor commit the institution to provide resources for the investigation. 5. If an investigator from an external institution is seeking to conduct research on the CCGA campus or requesting to use a CCGA data source must first seek IRB approval from their home institution. The PI must then apply for approval of research from the CCGA IRB by completing an official request to recruit human participants that includes a copy of an IRB approval from a FWA holding institution. If the data sought includes student records, the investigation must conform to CCGA and Federal regulations known as FERPA. The CCGA official in charge of enforcing FERPA regulations is the Registrar: Ms. Lisa Lesseig. The Registrar must approve the request for these types of data. If this research is approved by the home or other FWA holding institution's IRB and is deemed expedited or exempt, then CCGA IRB requires a copy of the IRB approval be submitted before beginning recruitment, obtaining consent, or data are recorded from the students, faculty, or staff of CCGA. If this research is approved by the external FWA holding institution's IRB and is deemed requiring full review (of greater than minimal risk or involving vulnerable populations), the PI may apply for reciprocal approval from CCGA’s IRB using the external institution’s IRB application materials and external IRB approval. However, the CCGA IRB may request any additional information from the external PI. The following should be submitted to the CCGA IRB: -A cover letter to the IRB Chair IRB@ccga.edu outlining the request -A copy of the approval letter from the external institution’s IRB -A copy of the senior investigator’s proof of ethical training (NIH, CITI or similar) -A copy of the IRB application for review of research from the PI’s external institution -A copy of the project methodology and informed consent documents -A copy of any recruitment materials utilized -A copy of data collection instruments used (survey, interview questions, etc.) -Appropriate contact information for the principal investigator (from the external institution) -Appropriate letter of cooperation from any other participating institutions if applicable In providing reciprocal approval, the College of Coastal Georgia will not be considered engaged in the research as per guidance from OHRP http://www.hhs.gov/ohrp/policy/engage08.html. However, the CCGA IRB reserves the right to evaluate the researcher’s methodology, consent and data collection 2 Rev. 1 October 2014 instruments, and other procedures to determine that human participants are adequately protected in the administration of the external institution's research. CCGA IRB Approval does not guarantee access to the college participants or their data; participants must give voluntary informed consent, and institutional data can only be provided in abeyance of other state and federal regulations. If the external institution is requesting archival data from the institution, upon approval, the CCGA IRB will forward the proposed research (including a copy of the CCGA IRB determination, external approval letter, the survey instrument, and informed consent document and recruitment announcement) to the appropriate administrative units listed below to approve the use of applicable University resources for the research. The administrative unit will consider, but not limit itself to the following questions: Is the data collection effort an acceptable use of College faculty, staff or student time? Does the data collection interfere with other data collection efforts (e.g. a similar survey sponsored by a CCGA affiliate in progress)? Is the research goal compatible with the College’s mission? CCGA Administrative Unit Contacts: Student Affairs and Enrollment Management, if student data pool access is requested: Contact – Registrar, Lisa Lesseig llesseig@ccga.edu ,(912-279-5737) Office of Academic Affairs (if faculty data pool access is requested). Contact – Interim Vice President of Academic Affairs, Dr. Lance Carluccio, lcarluccio@ccga.edu, (912) 279-5710 Fiscal Affairs, if facilities or business systems data are requested: Contact – Vice President of Fiscal Affairs, Jeff Preston, jpreston@ccga.edu, (912) 279-5751 Office of Institutional Advancement, if alumni data are requested: Contact - Vice President for Institutional Advancement, Elizabeth Weatherly, eweatherly@ccga.edu, (912)-279-5704 Human Resources, if staff or employment data are requested: Contact – Director of Human Resources, Phyllis Broadwell, pbroadwell@ccga.edu, (912)-279 5816 Office of Institutional Effectiveness, if other data are requested: Contact – Vice President for Institutional Effectiveness, Dr. Jim Lynch, jlynch@ccga.edu, (912)-279-5713 School of Arts and Sciences, CCGA Institutional FWA Designee: Contact - Dean Keith Belcher, Ph.D., kbelcher@ccga.edu, 912-279-5922 The CCGA IRB has the option to retain oversight of the research regardless of reciprocal approval and may choose to rescind project approval if concerns for the protection of human participants should arise. CCGA IRB approval of a project shall not be construed to overrule disapprovals from other campuses associated with the research or to serve as approval for any institution other than CCGA. CCGA IRB approval does not bind another institution or commit the institution to provide resources. CCGA does not provide administrative support for external researchers. Research protocols that have a CCGA co-investigator or collaborator requiring administrative support will be evaluated on a case by case basis. The CCGA faculty member, or the principal investigator from the collaborating or external institution, is responsible for providing information in response to requests for additional information and reporting 3 Rev. 1 October 2014 requirements, adequately supporting the designated IRB in its function, and abiding by the designated IRB decisions. (Modeled after Georgia Southern University IRB policy materials) 4 Rev. 1 October 2014