Minimal Risk Research
Minimal Risk Research is non-invasive and poses minimum risk to human subject participants. This type of research may involve surveys, questionnaires, observation, and other non-invasive data collection methods. Minimal risk research applications typically qualify for expedited review or are exempt from further review by the IRB. FDA regulated research, however, is always reviewed by the full board.
Non-Mercer affiliated faculty and student investigators seeking to conduct research involving Mercer’s students, faculty, or staff MUST have a Mercer University Faculty Member serving as a Faculty Sponsor of the project.
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.
Minimal Risk protocol applications include:
- A Complete Minimal Risk IRB Application with ALL required signatures (Dean, Department Chair, Faculty Advisor)
- Informed Consent Form(s)
- Informed Assent Form(s) - for research involving minors
- Evidence of approval by another IRB or Institution (Documentation of Permission to use patient data or student data from the appropriate institution’s administration)*
- Data Collection Instruments (questionnaires, interviews, online surveys, etc.)
- Advertisement/Recruitment Materials
*Any non-Mercer affiliated investigator seeking student information (including emails) MUST complete a Request for Student Information Form to be submitted with the application and forwarded to the Registrar’s Office upon approval by the faculty sponsor.
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 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.
If the application does not require Expedited or Convened Review, the IRB staff will indicate in a letter to the Principal Investigator that the study is exempt from further review. It is necessary to submit all non-funded applications to the ORC for review. If the study receives funding, the Office of Grants and Contracts receives a copy of the IRB letter sent to the Principal Investigator for inclusion into Office of Grants and Contracts' files.
If the application requires an Expedited Review, IRB staff forwards the application to the IRB Chair or his/her designee. The IRB Chair or his/her designee conducts the Expedited Review.
If the application requires a Convened Review, IRB staff assigns two Primary Reviewers to evaluate the application, discuss concerns with the Principal Investigator, and serve as advocates during the Convened Review. The principal investigator receives all information or revision requests from the Primary Reviewers through email and the ORC receives copied notes of the verbal and email communications. All IRB Board Members have access to the application and communications between the Primary Reviewers and the Principal Investigator via InfoEd. Upon completion of IRB review, the IRB staff 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 Expedited and Convened Review procedures in accordance with the policies and procedures outlined in Federal Regulation 45 CFR 46 (Expedited), and 21 CFR 50, 56, 312 and 812 (Convened) for Protection of Human Subjects 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 letter) of the termination of their research project and that subjects are not to participate in the investigation.
The IRB Meeting schedule submission deadlines do not apply to minimal risk protocol applications that do not require convened review, as they are reviewed upon receipt in the ORC. Annual renewal applications for expedited minimal risk protocols should be submitted for review at least two weeks prior to their expiration date to allow ample time for the application to be processed and reviewed.
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 or IRB Representative approves 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.
DO NOT SEND APPLICATIONS TO 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