IRB Board Policy & Procedures
IRB Policy & Procedures are currently under review and revision
Adopted from requirements defined in 21 CFR Parts 50, 56, 312, and 812 (Code of Federal Regulations and ICH (International Conference on Harmonization) guidance relating to GCP (Good Clinical Practice).
The College of Coastal Georgia IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human participants. In accordance with OHRP and FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research participants.
All IRB written notifications are reviewed, approved and signed by the Chair. The Chair may designate this function to the Vice Chair as appropriate. With the exception of community members, all IRB members must pass the approved Human Subjects Protections Program (e.g., CITI Training) and provide the IRB with a copy of the certification.Click here for the Board Membership roster and contact information.
- Proceedings of convened meetings of the Institutional Review Board, are confidential and not to be discussed outside of the meeting. IRB members will, at all times, maintain the confidentiality of the process and not discuss individual proposals outside of the IRB meetings with individuals or parties who may inquire.
- Individual members of the IRB will not make independent statements regarding IRB matters and are not authorized to individually speak for the IRB or on its behalf.
- Institutional Review Board files and records are confidential and available only to sponsoring/funding agencies, the US food and Drug Administration, the Office for Human Research Protections, or other agencies with the Public Health Service / Department of Health and Human Services, or institutional officials or their appointees who may be conducting internal audits for compliance purposes.
- Only the Institutional Review Board Office may disclose the approval status of a particular proposal.
- Digital confidential documents exceed IRB guidelines and are stored as required by Board of Regents (BOR) guidelines set forth for confidential faculty records.
- Complete copy of original application packet.
- Copies of all correspondence between IRB and investigators.
- Copy of Approval Notice.
- Copy of approved informed consent document.
- Continuing Renewal Request and Approval for Continuation.
- Modifications and copy of Modification Approval.
- Copies of agenda and minutes for each meeting to include attendance.
- IRB Submission Form
- Consent Forms
- Investigator Brochure if applicable
- Recruiting material
- Copies of CITI course completion certificates
- (Renewals of the CITI refresher course are due every 3 years, plus IRB 101 is required E/O year.)
An administrative review will be conducted to ensure completeness of the application. If the application is incomplete the principal investigator will be notified and requested to appropriately complete the application. An incomplete application will not be processed by the IRB.
- The risks to the subjects are minimized.
- The risks to the subjects are reasonable in relationship to anticipated benefits and the importance of the knowledge that may reasonably be expected to result.
- The selection of subjects is equitable.
- A process has been established for obtaining informed consent from each prospective subject or the subject's legal representative, in accordance with and to the extent required by DHHS and FDA regulations and the policies of the hospital.
- A process has been established to document informed consent.
- A procedure has been established to monitor the data collected to ensure the safety of subjects; and
- The investigational research plan adequately provides for the protection of privacy of subjects and the maintenance of confidentiality of data concerning those subjects.
- That applicable regulations for the protection of children (CFR 45: 46, Subpart D) are satisfied.
Whenever it is proposed during an investigation to perform any procedure involving any risk to a subject, informed consent should be obtained and documented. An investigator should seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject shall be in a language understandable to the subject or representative. No such informed consent, oral or written, should include any exculpatory language through which the subject is made to waive, or appear to waive, any of his/her legal rights, including any release of the investigator, the sponsor, or the institution, and its agent from liability for negligence.
Regulations permitting waiver of informed consent can be found at 45CFR46:116 and 21CFR50.23
The information provided to the subject or the subject's representative shall be written in language understandable to the layperson and shall include at least the following:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomfort to the subject and the precautions that will be taken to minimize those risks.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and the possibility that the FDA may inspect such records. Please reference Policy # 46:116a(b).
- An explanation as to whether any compensation for participation will be provided and whether any medical treatment will be available if injury occurs. If medical treatment will be available, the subject must be advised as to what it consists of or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and the subject's rights and whom to contact in the event of a research-related injury.
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate the following information shall also be provided to each subject:
- A statement that the particular treatment or procedure may involve risks to the subject which are unforeseeable.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without his or her consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject on a timely basis.
- The approximate number of subjects involved in the study.
- Final Approval
- The principal investigator will receive a written Notice of Approval from the IRB.
- The protocol may not be initiated until the principal investigator receives the Notice of Approval.
- The Notice of Approval will inform the investigator of the approval date, the approval period, the approval type (full committee or expedited), requirement for continuing renewal, requirement for approval of modifications, requirement for prompt reporting of adverse events, requirement of maintaining appropriate records, requirement that all staff involved in the research are informed and trained, and the IRB approved informed consent will be attached.
- Approval Pending Modifications
- Protocols that can be approved pending non-substantive clarifications of the protocol and/or minor revisions in the informed consent are in this category.
- The principal investigator will be notified in writing from the IRB what clarifications of the protocol or what revisions in the informed consent are requested.
- The letter will state the research may not commence until the investigator receives a Notice of Approval from the IRB.
- The principal investigator replies to any IRB correspondence within 90 days of receipt of the IRB correspondence. If there is no reply within this period, the pending file will be deactivated by the IRB and the investigator will be notified that the protocol has been withdrawn from consideration. Deactivated protocols are re-submitted as a new protocol. (see Section XXV for exception to this rule)
- Upon receipt of the clarifications or revisions the IRB Chairperson or his/her designee may grant final approval.
- The principal investigator will receive a written Notice of Approval from the IRB.
- The protocol may not be initiated until the principal investigator receives the Notice of Approval.
- Tabled or Re-Review
- Protocols with which the reviewers have substantive questions and about which there are concerns about protocol design, risks, and/or the informed consent will be reserved for this category.
- The principal investigator will receive a written communication regarding these concerns.
- The investigator must reply within ninety (90) days of the date of the IRB correspondence. Failure to reply within this time frame will result in the IRB deactivating the protocol. Should the investigator respond after the ninety (90) day deadline he/she will be informed that they must submit the protocol as a new submission.
- The investigator's reply will be provided to each IRB member and placed on the agenda for the next convened meeting.
- Each IRB member will determine if all issues and/or concerns have been adequately addressed and all requested revisions have been made.
- The IRB member will indicate on the review form one of the following:
- The protocol is now approved.
- Minor revisions are still needed.
- Issues/concerns have not been adequately addressed.
- The protocol will be placed on the agenda for the next convened meeting.
- When the re-review is discussed the IRB may give final approval, approve pending minor revisions, disapprove the protocol, or vote to re-review.
- The investigator will receive written communication regarding the IRB's disposition. If the IRB determines that more information is necessary before giving final approval, the principal investigator may be invited to attend the next convened meeting to present, in response to the concerns, a reply and defense of the protocol.
- After an open discussion, the investigator will leave the meeting and the IRB will vote.
- The protocol will receive full approval, pending approval, or disapproval by majority vote.
- The IRB disposition will be communicated to the investigator.
- The information submitted to the IRB by the investigator contains any untrue statement material to the IRB's decision making or omits information required by the IRB to review and evaluate the research that has been proposed.
- The report of prior investigations is inadequate to support a conclusion that it is reasonably safe to initiate or to continue the investigation.
- The principal investigator does not possess the scientific training and experience to qualify as an expert to investigate the safety and/or effectiveness of the test drug or medical device.
- The available appropriate resources for referral and/or consultation are inadequate to assure that the investigation will be conducted properly and in conformity with the proposed protocol.
- The investigational research does not conform to OHRP and/or is not being conducted in accordance with the approved protocol and/or the requirements of the OHRP and FDA and the institution pertaining to human subject research.
- whether the risks to the subject are so outweighed by the benefits to the subject and the importance of the knowledge to be gained as to warrant a decision to approve the research and thereby allow the subject to accept the risks;
- whether the rights and safety of the human subjects will be adequately protected;
- whether informed consent will be obtained by adequate and appropriate methods in accordance with applicable requirements governing such research;
- Whether the proposed investigation will be or is being reviewed by the sponsor and/or by the IRB, as appropriate, at intervals appropriate to the degree of perceived risk.
If the IRB has granted final approval and the study is withdrawn or terminated, the investigator must complete and submit an Annual Renewal Form by entering the date the study closed or terminated. The Vice President for Academic Affairs may also approve termination as deemed necessary.
Approval by the IRB of Collaborative research protocols may be subject to further appropriate review by other facilities conducting the research. However, Coastal Georgia's IRB or their designee shall not overrule disapproval of such a protocol by the IRB. The IRB's decision to disapprove a protocol will be communicated to the investigator in writing and will include the reasons for disapproval.
Any suspension or termination of approval shall be reported to the investigator, Coastal Georgia's IRB and where appropriate, the sponsoring agency.
If the IRB decides to suspend or terminate a research protocol, it shall include in its order, provisions regarding any subject who has previously been allowed to participate in the protocol and who either would have continued to receive the test article or who remains under the supervision of the investigator. Such provisions shall take into account among other factors, the risks to the subject from the withdrawn article or from its continued administration by another researcher, the need for further supervision, the availability of qualified personnel, and the rights of the subject to include the right to participate in the decision as to future care.
- Continuing Review Overview
- The IRB shall review a research protocol annually that has been approved, until the protocol is concluded or discontinued. The length of time before IRB continuing review needs to occur is determined by the IRB at initial review.
- The purpose of continuing review is to evaluate whether research continues to satisfy the criteria for IRB approval of research. Although an IRB may become familiar with various individual aspects of the research project’s conduct, such familiarity does not relieve the IRB of the responsibility to conduct continuing review at least annually, which provides an opportunity to reassess the totality of the project and assure that, among other things, risks to subjects are being minimized and are still reasonable in relation to anticipated benefits, if any, to the subjects and the knowledge that is expected to result.
- Continuing Review Process and Timeline
- The Continuing Review shall be undertaken at intervals appropriate to the degree of risk as determined by the IRB, but shall not be less often than once per year, to assure that the protocol is being conducted in compliance with the requirements and understanding of the IRB and all applicable regulations.
- Research-approval documents will indicate due dates and any research requiring continuing review will be notified. Annual is the standard.
- The IRB shall provide the investigator with a Continuing Renewal Request at the 11th month following the initial approval date or last continuing approval date.
- Continuing Renewal Requests are subject to the IRB deadline date of three weeks prior to the next convened meeting.
- IRB reviews Continuing Review documents and will:
- approve the Continuing Review
- request revisions
- deny the Continuing Review
- Once approved, investigators and the VPAA will receive a formal letter showing results of the continuing review process.
- Continuing Review Requirements
- Expedited: Continuing review of research previously approved using the expedited process will be reviewed using the expedited process.
- Other than expedited: All other continuing review requests will be reviewed at a convened meeting.
- On-site reviews:
- The IRB reserves the right to perform an on-site review. This may include a Board member(s) observing the informed consent process, reviewing the study records and documenting that the approved informed consent is being utilized
- Investigator Responsibilities
- Consequences for noncompliance
- Failure by the investigator to respond to the Continuing Renewal Request within 30 days after the renewal due date will result in the termination of the protocol, and all research activities must cease.
- Notification of termination will be sent to the VPAA.
- OHRP notes that it is the responsibility of investigators to provide in a timely manner the information needed by the IRB to perform its continuing review functions, and any reminder notices regarding the need to do so from the IRB to investigators are a courtesy. IMPORTANT: If investigators wish to continue, they must submit their continuing renewal.
- In general, IRB review of a proposed change to a research project during the period for which approval is authorized does not continuing constitute review of the project as a whole, and thus does not extend the date by which continuing review must occur (e.g., beyond one year from the effective date of the initial approval or the most recent continuing review approval).
If the investigator does not report the termination he may do so when he receives the next Renewal Request.
When a protocol has been terminated the IRB file will be placed in the inactive files and if an investigator wishes to re-instate the protocol he must submit a new application to the IRB.
Any such proposed changes in the protocol or informed consent must be approved by the IRB before implementation or use by the investigator.
The Chairperson or his/her designee will review all amendments to protocols and revisions to informed consents and determine whether the proposed changes are substantive. Minor changes will be considered under the Expedited process and the proposal will be placed on the agenda for the next convened meeting.
If the proposed change(s) is/are judged by the IRB Chairperson or his/her designee to be substantive, the proposal must be reviewed by the full IRB and approved before the change can be implemented. Substantive changes include procedures involving increased or different risks, additional discomforts, or new procedures.
Unanticipated risks may be discovered during the course of a protocol, or new information indicating that the risks in a protocol are not justified may be discovered. Unanticipated risks or new information that may affect the risk/benefit ratio must be promptly reported to and reviewed by the IRB to insure adequate protection of the welfare of the subjects. Based on such information, the IRB may reconsider its approval of the protocol or institute new conditions for continuation and review.
The IRB will provide written approval of all modifications to the investigator. In cases where the informed consent requires revisions, a copy of the informed consent indicating IRB approval with the approval date will be provided to the investigator.
A Serious Adverse Event Report must be completed with a written narrative that includes sufficient detail for a thorough review by the IRB.
Failure to report an occurrence in a timely manner may result in temporary or permanent suspension of the protocol.
The Chairperson or his/her designee will review each report of an adverse event and will determine whether the report requires action.
If the reported event is deemed non-substantive or not due to the treatment or protocol, the adverse event will be placed on the agenda for the next convened meeting, discussed and recorded in the minutes.
If it is determined that the event requires further action, additional information or merits discontinuation of the protocol, the Chairperson will immediately contact the investigator and a member of the College of Coastal Georgia's IRB or its designee to suspend the protocol if warranted, or further investigate the event.
These reports will be reviewed by the IRB Chairperson or his/her designee and placed in the permanent IRB file and reviewed by the Chairperson or his/her designee with the next Continuing Renewal Request.
If IND Safety Reports significantly alter the risk/benefit ratio to the subjects, the IRB may request revisions to the informed consent or suspend or terminate the protocol.