SOP: #IRB# - College of Coastal Georgia

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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
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
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
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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
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requirements, adequately supporting the designated IRB in its function, and abiding by the designated
IRB decisions.
(Modeled after Georgia Southern University IRB policy materials)
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