Determining if IRB Approval is Needed

Purpose

The purpose of this policy is to outline the definitions of ‘research’ and ‘human subjects’ and the CRC IRB procedure for determining when projects do and do not require IRB review and approval.

Policy

Activities that meet the federal definition of ‘human subjects’ at 45 CFR 46.102(e) and ‘research’ at 45 CFR 46.102(l) require IRB review and approval. The Charles River Campus (CRC) IRB is responsible for determining whether activities and projects meet these definitions and when or whether IRB review and approval is required. An IRB Member who is designated as an expedited reviewer by the IRB Chair may make these determinations.

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

To be considered a “systematic investigation,” the concept of a research study ordinarily:

• Attempts to answer research questions (for example, a hypothesis),
• Is methodologically driven (data/information are collected in an organized/consistent way), and
• Conclusions are drawn from the results.

To be considered “generalizable knowledge,” the activity ordinarily includes the following concepts:

• The information gained contributes to a theoretical framework of established knowledge,
• Results are intended to be generalized to a larger population beyond the site of data collection or population studied, and
• Results are intended to be replicated in other settings.

The following activities are deemed NOT to be research:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Human Subject is defined as a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

To meet the definition of a ‘human subject’, the following must apply:

• The ‘subjects’ are currently alive,
• The information to be collected is about the ‘subjects’ (e.g. personal information about the individuals), and:
• Information/biospecimens are collected by an intervention (physical procedures and manipulations of the subject or the subject’s environment for research purposes) or an interaction (communication or interpersonal contact between investigator and subject) AND the Investigator uses, studies or analyzes the information/biospecimens, OR
• The Investigator obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

Procedures

To receive an official determination of whether a project is Research Involving Human Subjects, Investigators should complete and submit the Research with Human Subjects Determination Form and submit it along with any supporting materials, such as a grant or contract supporting the research, data collection forms, and other materials (e.g. assessments, questionnaires, etc.) to be used in the project. Informal inquiries into whether IRB review and approval may be needed do not require submission of the Determination Form.

Review Process

1. When received, the IRB Coordinator assigns the Determination Form a study number, enters it into the tracking system, and screens the Form for completeness. If information/material is missing, the IRB Coordinator will request this information/material from the PI. The Coordinator will provide the file to the IRB Analyst responsible for the reviews of the submitting PIs Department.
2. The IRB Analyst will review the Form to determine if the activity meets the definitions of ‘research’ and ‘human subjects’.
3. If the IRB Analyst requires additional information, they will contact the PI via e-mail and review the PI’s response upon receipt. If the PI does not respond within 60 days, the determination inquiry will be withdrawn. If the IRB Analyst does not believe that the materials received are sufficient, the Analyst may request that the PI make further clarifications and/or revisions. This process will continue until a determination can be made.
4. Once the IRB Analyst makes the determination, the Form with the signed/dated determination will be sent back to the Investigator as official documentation.

Author: Pamela Richmond
Date: April 7, 2020
Approved: CRC IRB, Kathryn Mellouk, Institutional Official