Clinical Trials are invasive Greater than Minimal Risk Medical Research studies involving human subjects.
As defined in the 2018 Final Rule, a Clinical Trial is "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes."
FDA regulated studies must always be reviewed by the Full Convened Institutional Review Board.
The review process of every research application begins with a complete submission to the Office of Research Compliance (ORC). In preparation for IRB review, the ORC staff works closely with the Principal Investigator to prepare the required IRB documents for their research project.
Clinical Trial protocol applications for Greater than Minimal Risk Review include:
- A Complete Clinical Study IRB Application with ALL required signatures (Dean, Department Chair, Co-PI)
- Informed Consent Form(s)*
- Informed Assent Form(s) - for research involving minors
- Data Collection Instrument(s) (questionnaires, interviews, online surveys, etc.)
- Investigator's Assurance
- Letter of Permission or IRB Approval from Off-Site Institution (Off-Site Reserch Agreement)
- Advertisement/Recruitment Materials
- Sponsor Protocol/Master Protocol
- Investigator's Brochure
*In accordance with the 2018 Revised Common Rule, a copy of an IRB-approved version of the consent form used for enrollment purposes must be posted to ClinicalTrials.gov for all federally-sponsored clinical trials conducted through Mercer University. Consent forms must be posted after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject (as required by the protocol).
Once an application is determined to be complete, the ORC formally accepts it and the IRB review process begins.
Upon receipt of all required paperwork, the Associate Director of Human Research Protection Programs (HRPP) assigns Clinical Trial applications two primary reviewers who will evaluate the application, discuss concerns with the Principal Investigator, and serve as advocates during the Convened Review.
All submitted documentation will be logged, scanned, and uploaded to the InfoEd electronic data management system. From there the application is assigned a protocol number and reviewed for completeness. After being assigned a protocol number, Primary Reviewers are assigned to the application and it is placed on the agenda for the next IRB meeting. The principal investigator receives all information or revision requests from the Primary Reviewers via email and the ORC receives copied notes of the verbal and electronic correspondence. When the full board convenes and reviews the application, the Primary Reviewers serve as advocates for the Principal Investigator. All IRB Board Members have access to the application and communications between the Primary Reviewers and the Principal Investigator via InfoEd prior to the meeting. When the IRB's review is completed, the Associate Director of HRPP notifies the Principal Investigator in writing of the application's status.
The IRB conducts continuing review of all research, funded or non-funded, and approved through the Convened Review procedures in accordance with the policies and procedures outlined in Federal Regulation 21 CFR 50, 56, 312 and 812 at intervals appropriate to the degree of risk, but not less than once per year for the life of the project.
No study continues beyond the one-year approval without IRB review.
Convened Review applications approved by the full board must undergo the same Convened Review Process for the continuation of the project.
It is the Principal Investigator's responsibility to secure continuing approval. The Principal Investigator should allow adequate time for the review process to ensure the application can be approved prior to the expiration of the approved study period. The ORC sends Principal Investigators with expiring protocols two week reminders about upcoming Convened Review submission deadlines. When the Principal Investigator fails to obtain continuing approval for their project, the ORC notifies the Principal Investigator (through telephone, e-mail, and/or letter) of the termination of their research project and that subjects are not to participate in the investigation (except for a medical emergency).
Continuing review information submitted to the IRB should include information such as:
- The number of subjects entered into the research study
- A summary description of subject experiences (benefits, adverse reactions)
- Numbers of withdrawals from the research; reasons for withdrawals
- The research results obtained thus far; a current risk-benefit assessment based on study results; and
- Any new information since the IRB's last review (e.g., unanticipated risks discovered after the last review)
If the Principal Investigator, during the course of conducting the research, needs to revise the application (e.g., makes changes to the informed consent form or conduct of the study, survey instruments used, or number and nature of subjects), the Principal Investigator must notify the IRB and seek approval prior to making any changes. The Associate Director of HRPP will notify the original Primary Reviewers and they will determine the need and degree of additional IRB full review for approval.
The Principal Investigator must submit in writing any intended changes of the study to the IRB using the, Request for Modification/Amendment form. The Principal Investigator must keep in mind that the implementation of changes cannot occur until the IRB and Designated Representatives approve the changes, and that failure to do so may result in the application's suspension and/or termination.
NOTE: For investigations initially approved by Convened Review, changes that alter the degree of risk to the subjects also require Convened Review.
The IRB requires Principal Investigators conducting approved research to submit in writing notification of the completion of their project to the ORC. The principal investigator shall provide written notification within 30 days of completion or the termination of all research activity for a study.
Joint Protocol Review
This institution promotes collaborative research by working with various external institutions, institutional review boards, and independent investigators. When multiple institutions are involved in research, the IRBs of these institutions are responsible for overseeing the research activities and enforcing compliance to all applicable federal and state laws.
Mercer FWA Number – FWA 00000133
Mercer IRB Registration Number – IRB 00000910
ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry" and "results database." In October 2008, the 59th World Medical Association (WMA) General Assembly amended the Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. In particular, paragraph 19 requires prospective trial registration, as follows: "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject." Paragraph 30 promotes the public disclosure of study results as an ethical obligation and states, in part, "Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available." The ClinicalTrials.gov registration requirements were expanded after Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trial registration information to be submitted. The law also requires the submission of results for certain trials.
DO NOT SEND APPLICATIONS TO MERCER LIVE OR CANVAS
ELECTRONICALLY SUBMIT MERCER IRB FORMS TO: ORC_Research@Mercer.edu
To send versions with original signatures, use campus mail addressed to:
Attention: Ava Chambliss-Richardson, Ph.D.
Director of Research Compliance
Office of Research Compliance
1501 Mercer University Drive
Macon, GA 31207
To Fax an application: 1-478-301-2329