Revision Date: 2023.12.15

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Table of Contents

I. Description

This RM is designed to describe the process of determining whether an IRB application should be included in a grant submission.

II. Objectives

Determine whether a grant application should include an IRB submission.

III. Scope

IRB determinations involve the review and approval of Governance in collaboration with relevant Scientific and Operations Stakeholders.

IV. Procedures

Step 1: Research Definition

Determine if the project meets the definition of Research as defined by the U.S. Department of Health and Human Services regulation.

IRB review and approval is required for projects that:

• Meet the definition of research

• Involve human subjects and include any interaction or intervention with human subjects or involve access to identifiable private information

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(l))

A Systematic Investigation follows a predetermined plan for looking at a particular issue, testing a hypothesis or research question, or developing a new theory that may include:

• Collection of quantitative or qualitative data

  • Typically, the sample size must comprise of at least three human subjects.

• Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups

• Collection of data using experimental designs such as clinical trials

• Observation of individual or group behavior

Contributing to generalizable knowledge means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. This may include one or more of the following:

• Presentation of the data at meetings, conferences, seminars, poster presentations, etc.

  • Note: some presentations of data do not automatically make the information “generalizable.” Example: The poster summarizes observations of a project but is not making research-related claims.

• The knowledge contributes to an already established body of knowledge

• Other investigators, scholars, and practitioners may benefit from this knowledge

• Publications including journals, papers, dissertations, and master’s theses

If the project does not meet the definition of research (i.e. is not a systematic investigation or does not contribute to generalizable knowledge), as described above, then the project does not require IRB review and an IRB application is not required.

Step 2: Research Determination

Does the project meet the definition of research stated above?

✅ Yes (IRB submission required)

🛑 No (IRB submission not required, stop here)

Step 3: Human Subjects Definition

Are Human Subjects Involved? (45 CFR 46.102(e))

A Human Subject is a living individual about whom an investigator conducting research obtains:

(1) data through intervention or interaction with the individual or

(2) identifiable private information.

Interaction–Any communication or interpersonal contact between the investigator(s) and the subjects. This includes in-person, mail, telephone, etc. Online surveys (even if anonymous) involve interaction.

Intervention–Physical procedures or manipulations of the subject or his/her environment (e.g. taking blood samples, exercise studies, use of devices, cognitive tasks, etc.)

Regarding DCC functions:

The management and operation of a data coordination center (DCC), in itself, does not constitute human subjects research. Often in the scope of a DCC, Sage is not authorized to develop their own scientific hypotheses. In these cases, the project will not be considered research.

Step 4: Human Subjects Determination

Does the project involve Human Subjects?

✅ Yes (requires IRB review, continue to Step 5)

🛑 No (IRB review is not required, stop here)

Step 5: Exemption Decision

If yes, the last step is to determine whether full board review is required or if the project may be eligible for an exemption determination.

Reference the following decision charts to determine whether the protocol may be considered exempt. All project activities must fit within one or more of the exemption categories defined at 45 CFR 45.104. If the research does not fit strictly within these categories, the project is not eligible for exemption.

V. Revision History