Medical Board Review
Medical Board Review Process
Medical board review applies to human subjects research that involves the use of blood or body fluids, ingestion, injection or inclusion of a food products, supplement, or similar product related to an intervention or evaluation and physical interventions. If assigned to medical board, you have the opportunity to be available during the meeting to provide additional information or answer questions. These studies may require submission to Clinical Trials.gov.
Studies that involve IND or IDE or meet the FDA definition of a medical Clinical Trial must be reviewed by an external Institutional Review Board. The cost of external review should be included in sponsor and external budgets or provided by investigator identified sources. These studies must be submitted to Clinical Trials.gov prior to enrolling the first subject. Medical Device Procedures are located here.
The research proposal is presented and discussed at a meeting at which a quorum of IRB members who have relevant medical expertise are present. For the research to be approved, it must receive the approval of a majority of those voting members present. (Note that, in effect, an abstention counts as a negative vote.)
Continuing Review Required
Medical full board research projects are reviewed annually for renewal and can be renewed as long as the project remains ongoing. The IRB application pieces (narrative, informed consent, etc) must be updated to accurately reflect the research to receive renewal.
This approval path may require a minimum of 4 to 8 weeks to complete. The Medical Review Board meets on a called basis.
Preferred submission method: Single email to irb@georgiasouthern. Applications with hand written signatures can be scanned and emailed or official Adobe electronic signatures are accepted.
|Form Name||Additional Form Information|
|IRB Application||Complete for all expedited and full board reviews. Note: Do not include dissertation or thesis chapters. Information required for review must be condensed into the application format.
REQUIRED FOR ALL EXPEDITED AND FULL BOARD- replaces the previous cover page and narrative forms.
|COVID Safety Plan||All research that includes procedures that require in person interaction with participants requires a COVID safety plan. The type of plan is dependent on the research. Follow the decision tree to the correct form for your research.|
2 Courses – Human Subjects Basic and Good Clinical Practice (GCP) for Clinical Research
CITI Program training provides social/behavioral content training. Online certificate will be provided to you once the course is completed. Attach certificate or transcript to each protocol submitted. Certificates are not maintained by the IRB. Training certificates from previous submissions are not readily available. Click here for instructions. REQUIRED EACH TIME YOU APPLY.
GCP training will differ for Medical Device studies or New Drug studies. Choose your training module to match your study.
|Informed Consent Sample||This is a sample of an informed consent document provided on an electronic version of GS letterhead. Any information in the sample should be edited as appropriate for the population you are using and the type of research you are conducting. Click here for further information on HIPAA consent criteria.|
|Informed Consent Checklist||Tool for the construction of an Informed Consent document. – REQUIRED|
|Waiver Application||Use this form to request a partial (recruitment only) or full waiver of authorization for medical records review.|
|HIPAA De-Identification Certification Form||Use to certify receipt of medical data in a de-identified format for HIPAA Safe Harbor purposes|
|Minor’s Assent Form Sample||This is a sample of a minor assent document provided on an electronic version of GS letterhead. Any information in the sample should be edited as appropriate for the population you are using and the type of research you are conducting. Your assent should be on a reading level appropriate for the participant’s age.|
|Parental Informed Consent Sample||This is a sample of a parental consent document provided on an electronic version of GS letterhead. Any information in the sample should be edited as appropriate for the population you are using and the type of research you are conducting.|
|Instrument||Please include a copy of all instruments to be used in the research (surveys, questions, etc.)|
|Recruitment Materials||Please include a copy of all materials to be used for recruitment (flyers, emails, etc.)|
|Supplement study only – Nutritional label and/or content||Informed consent must either list potential allergens or request a list of known allergies from participant for match to the ingredient list.|
|Georgia Southern Survey Policy||Georgia Southern’s Policy on the distribution of surveys to faculty, staff, and students.|
|Sample Letter of Cooperation (LOC)||If subjects are students or employees of another institution, include a written letter of cooperation from the subjects. This may be a letter or email from the institutional official’s professional address with the institutional officer and title identified in the email body. All letters of cooperation must clearly identify the investigator and project by title. (See the FAQ for additional information.) Note: If using education data obtained from school records you must include documentation of parental permission for the release of such data under the Family Educational Privacy Act (FERPA). This may be a copy of the release form, informed consent, or an assurance from the institutional official that such permission has been obtained prior to data release.|
|Medical SOPs||Standard Operating Procedures related to medical IRB applications|
Last updated: 9/11/2020