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Chapter VIII - Determination if Planned Activity is not Research or Research not Involving Human Participants

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Sometimes it is necessary to have the IRB determine whether the planned activities are covered by the regulations for the protection of human participants. This is important:

  • To help ensure that the rights and welfare of human participants are protected for research in accordance with the regulations; AND

  • To avoid applying the regulations unnecessarily to activities not covered by the regulations.

When in doubt, investigators should submit inquiries to the Genetic Alliance IRB to obtain guidance and details on which form to submit: either a “Request for a Determination of Not Research or Research Not Involving Human participants”, or a “Request for Exemption Determination”.

Note: The above determinations must be issued proactively, before the initiation of the project or study. The IRB will not provide a formal written determination after the project has been initiated.

DETERMINATION OF REVIEW PATHWAY BY THE GA IRB OFFICE
Protocols submitted for review will undergo an initial assessment of whether the activity meets the definition of human participants’ research based on the definitions in 32 CFR 219.102, assessment of the study’s probable risk level, and preliminary review of protocol and associated materials. The review will also include an assessment for a basis for an exemption determination by consulting the exemption criteria at 32 CFR 219.101.b; or the basis for expedited review. Subsequently, the GA IRB Chair or designee provides the final determination regarding whether the activity is human participants research, and whether the project qualifies for expedited review or requires full Board review.

CRITERIA FOR DETERMINATION OF NOT RESEARCH OR NOT HUMAN PARTICIPANTS RESEARCH
The GA IRB Chair or designee (aka IRB reviewer) can make the following determinations:

  • The activity does not meet either the definition of research as specified under 45 CFR 46.102 (d) or the definition of clinical investigation as specified in 21 CFR 56.102 (c);
  • The activity is research but does not involve human participants 45 CFR 102 (f) or 21 CFR 56.102 (e).

In making this determination, the following are used as references: 1) OHRP’s decision Chart #1 "Is An Activity Research Involving Human Participants?" 2) the DHHS or U.S. Food and Drug Administration (FDA) definition of “human participant research,”, 3) the definition of the scope of clinical investigations regulated by the FDA, and 4) consideration as whether the project is research vs. quality/process/performance improvement.

OHRP DECISION CHART
The IRB reviewer refers to the OHRP’s decision Chart #1 "Is An Activity Research Involving Human Participants?"

In making the determination, the IRB reviewer considers the following questions:

  • Does the project meet the regulatory definition of “research” (32 CFR 219.102(d))?
  • Does the research involve “human participants” (32 CFR 219.102(f))?
  • Is the research exempt from human participants’ research regulatory requirements in accordance with any of the 6 exemption criteria identified through the Common Rule?

Examples of Activities That May Not Involve Research:

  • Activities that are not systematic investigations may include:
    • Training activities;
    • Classroom exercises where the objective is to teach proficiency in performing certain tasks or using specific tools or methods.
  • Activities that do not contribute to generalizable knowledge may include:
    • Case reports or case series;
    • Resource utilization review;
    • Quality assurance/improvement, program evaluation efforts, Process Improvement projects;
    • Survey/questionnaire development when data are not retained for research purposes.
  • Public Health Surveillance;
  • Outbreak Investigations;
  • Activities may involve “research” and “process improvement” or other types of activities.

FDA REGULATIONS
The IRB reviewer refers to 21 CFR 50.1 (a) for a definition of the scope of clinical investigations regulated by the U.S. Food and Drug Administration. Activities that meet any of the following criteria do not qualify for the "No Human Participant Research Designation."

  • Any use of a drug or medical device not approved by the FDA, regardless of the presence of an IND or IDE;
  • Any use of a drug in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of research) other than the use of an FDA approved drug in the course of medical practice;
  • Any use of a medical device in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of research) other than the use of an FDA approved medical device in the course of medical practice;
  • Any use of an FDA regulated item in which the data will be submitted to or held for inspection by FDA.

DHHS OR FDA DEFINITION OF “HUMAN PARTICIPANT RESEARCH”
The IRB reviewer may determine that the proposed activity is human participant research because it meets the DHHS definition of research (45 CFR 46.102(d)); and involves individuals who meet the definition of a human participant (45 CFR 46.102(f); or meets the FDA definition of clinical investigation.

For activities determined by the IRB reviewer to meet either the DHHS or FDA definition of “human participant research,” the principal investigator is advised to resubmit the research for exempt, expedite or full-board IRB review, as appropriate.

RESEARCH VS. QUALITY/PROCESS/PERFORMANCE IMPROVEMENT
It is sometimes challenging, particularly for clinical studies, for the IRB reviewer must consider ‘yes’ or ‘no’ as to whether the work is “research” or process or quality improvement and answer:

  • Does the analytical or evaluative component of the activity change the way that the clinical care will be delivered in such a way that risks may be higher for providers or patients who participate (e.g., will providers or patients be randomized to different interventions to permit statistical comparison of outcomes)?
  • Is there funding from an external organization based on support of a “research paradigm” to carry out the proposed activity?
  • Does the project seek to test interventions that are beyond current science and experience, such as new treatments? Does the project involve care practices, interventions, or treatments that are not standard (neither consensus-based, nor evidence-based)?
  • Are patients or providers randomized into different intervention to enhance confidence in differences that might be obscured by nonrandom selection?

Distinguishing Research from Quality/Process/Performance Improvement

DETERMINATION NOTIFICATION: NOT RESEARCH OR NOT HUMAN PARTICIPANTS RESEARCH
The principal investigator of the research activity is notified of IRB concurrence of either “Not Research or Not Human Participants Research” status in writing. This notification letter specifies the regulatory basis for granting the Not Human Participants Research status:

  • Concurrence that the project does not meet either the definition of “research” as defined in 45 CFR 46.102(d) or 21 CFR 56.102(c); or the definition of “human participants” at 45 CFR 46.102(f) or 21 CFR 56.102(e); AND
  • That the IRB should be notified in advance of any proposed substantive modifications of the activity.
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