| This procedure describes how UAB reviews human subjects research to determine if it qualifies for exemption from the human subjects regulations in accordance with 45 CFR 46.101 and 21 CFR 56.104. This procedure also describes how research exempt from human subjects protection regulations may undergo ethical review. This procedure is not to be used to grant exemptions under the FDA category 21 CFR 56.104(c) for emergency use of a test article in a life-threatening situation.
PROCEDURE
Investigator Responsibilities
An investigator submits the following materials, if applicable, to the OIRB:
- Completed IRB Application eForm (FOR200), including documentation of review from the Faculty Advisor/Course Instructor if the Principal Investigator is a student;
- Any questionnaire, survey, or test instrument to be given to participants;
- Any tools used for recruitment, screening, or consenting participants;
- Any data collection forms, observation forms, or list of variables to be obtained;
- Special approvals (e.g., FERPA approval from site, if applicable; site approvals for conducting research; external IRB determinations or approvals);
- Include the Office of Sponsored Programs (OSP) proposal number for any funding source (e.g., grant, contract, fee-for-service) or data use agreement (DUA);
- A release form or letter for obtaining existing data, documents, records, or pathological or diagnostic specimens from the head of the department responsible for providing the material.
- Material Transfer Agreement (MTA) number for outgoing material;
- Obtain IRB determinations or approval from non-UAB site IRB or, if no IRB, determination letter from site acknowledging and agreeing to allow conduct of study at site.
In alignment with the Belmont Principles and UAB policies, researchers are expected to provide subjects with the following information when the research involves interacting with subjects: - The title of the project, including the IRB protocol number;
- The purpose of the research;
- A statement that the activity is research and that participation is voluntary;
- An opportunity for subjects to choose whether to participate in the research;
- A description of the study procedure(s) and the approximate time of the participant’s involvement;
- A statement regarding the confidentiality of the data to be obtained;
- Alternatives, if applicable;
- Student/employee language from the UAB IRB sample consent template;
- The Principal Investigator’s name, affiliation, and contact information;
- Contact information for the UAB IRB as noted in the UAB IRB sample consent template;
- Informing parents in advance that their children will be participating in research. (Note: this may not be sufficient to satisfy the requirements of the FERPA regulations, which are separate and distinct from human subjects’ regulations.) Mechanism for providing this information must be included in the initial submission.
OIRB Responsibilities
Administrative staff:
- Receives initial submission.
- Assesses general completion of the submission.
- Enters general submission information into the electronic system (e.g., sponsor, number of participants).
- Assigns the submission to a reviewing staff member.
- Sends the monthly report to IRB members itemizing exempt protocols reviewed under limited IRB review procedures.
Review staff:
- Reviews the initial submissions and determines if research qualifies for exemption using the criteria in 45 CFR 46.104(d)(1-6).
- Checks to ensure the following materials are in the record: packet:
- IRB Application eForm;
- Any correspondence related to the application;
- Application for extramural funding, if applicable. if not already available in IRAP;
- Information for adequate provisions to protect the privacy of the individuals and maintain the confidentiality of the data are present for studies meeting the criteria for Limited IRB Review, if applicable; and
- Other supporting documents;
- Ensures criteria for Limited Review (see PRO120) are documented, if applicable, in advance of IRB member review.
- Prepares communications to the Principal Investigator regarding the review including, as appropriate:
- Request for further information;
- Notification that the protocol is not eligible for exemption, the reason, and recommended future course of action;
- Notification that the protocol is not eligible for exemption, the reason, and recommended future course of action;
- Notification of designation accompanied by a determination date;
- Notification that because the research project is potentially ethically problematic, it is not eligible for exemption and will need to undergo IRB review; and
- Notification that any modifications to the protocol require review to assure the modifications do not change the exempt status of the protocol.
- Documents the determination including the exempt category satisfied by the research.
IRB Responsibilities
Chair (or delegate): - Reviews components of exempt protocols using the limited IRB review procedure, as applicable.
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