OBJECTIVE:

To describe the activities which meet the regulatory definition of human research and come under the scope and authority of the VCU IRB and how determinations are made.

DESCRIPTION:

A.     Definitions:

1.       Applicable DHHS Definitions:  VCU conducts all research in accordance with any applicable DHHS definitions (as provided below). 

a)      Human subject: a living individual about whom an investigator conducting research obtains: data through intervention interaction with the individual or identifiable private information. 

b)      Research:  a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration) [regulations at 45 CFR 46 as enforced by the Office for Human Research Protections]. 

c)      Supporting Definitions:

i)           Intervention includes both physical procedures by which data are gathered (e.g., drawing blood) and manipulations of the subject or the subject's environment that are performed for research purposes. 

ii)         Interaction includes communication or interpersonal contact between investigator and subject. 

iii)        Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical record information).  Since the definition of a human subject is a "living" individual, research involving autopsy materials or cadavers is not considered human subjects research and is not reviewed by the IRB [regulations at 45 CFR 46 as enforced by the Office for Human Research Protections]. 

2.       Applicable FDA Definitions:

a)      Human Subject:  an individual who is or becomes a participant in research, either as a recipient of the test article or as a control and/or an individual on whose specimen a device is used.  A subject may be either a healthy human or a patient [regulations at 21 CFR 50  as enforced by the Food and Drug Administration].

b)      Clinical Investigation: a 'clinical investigation' or experiment involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i), 507(d), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of Part 58 of this chapter, regarding nonclinical laboratory studies [regulations at 21 CFR 50  as enforced by the Food and Drug Administration].

c)      Test Article: any drug (including a biological product for human use ,medical device for human use, human food additive, color, adaptive, electronic product, or any other article subject to regulation under the jurisdiction of the FDA.

B.     Authorization to Make Determinations:

Each activity undertaken on behalf of Virginia Commonwealth University must be evaluated  by the individual most familiar with the planning and development of the activity.  Therefore, it is the responsibility of individuals to make appropriate determinations following this policy.  When an individual makes the determination that an activity does not constitute human research, the VCU IRB recommends that the individual document that such a determination has been made in writing and request Department Chairperson (or designee) acknowledgement.  These records should be retained with activity/research records.

If a determination cannot clearly be made, the individual must submit the activity to the VCU IRB for determination.  If the IRB subsequently determines that the activity does not constitute human research, their decision will be documented in writing to the principal investigator.

C.     Procedure for Determining What Constitutes Human Research:

Activities that are regulated as human subjects research include those activities that meet the definitions - "research" and "human subject" under the DHHS regulations and/or those that meet the definitions of "clinical investigation" and "human subject" under the FDA regulations.  The FDA regulations define "research" to be synonymous with "clinical investigation."

Any individual planning an activity that may fall under these regulations must:

1.       Review the DHHS definitions, first considering whether the activity is research, and if so, whether it involves human participants.  This two-step approach is required for all research, regardless of source of funding (in accordance with the VCU Federalwide Assurance).

AND

2.       Review the FDA definitions and determine if the activity is regulated by the U.S. Food and Drug Administration.

If the activity meets either the DHHS set of definitions or the FDA definitions (or both), then an application for approval of the activity must be submitted to the VCU IRB.

The following decision chart is recommended for determining if the activity qualifies as human subjects research under the DHHS definitions (see Chart 1):

OHRP Human Subject Research Decision Charts

The following decision charts are also suggested for review as resources:

•          For determining if the coded data represents human subjects (OHRP Guidance Document:  Coded Private Information or Biological Specimens )

•          For determining if VCU is engaged in the research activity (OHRP Guidance Document:  Engagement of Institutions in Research)

D.     Scope:

All human research (a) meeting the definitions described above and (b) under the authority of VCU, must be reviewed and approved by one of the IRBs relied upon by VCU prior to the onset of any human research interaction.

In fulfillment of its mission and purpose, the VCU exercises the authority to protect all human subjects involved in research (both exempt and nonexempt), where one or more of the following apply:

1.       The research is sponsored by the institution, or

2.       The research is conducted by or under the direction of any employee or agent of the institution in connection with his or her institutional responsibilities, or

3.       The research is conducted by or under the direction of any employee or agent of the institution using any property or facility of the institution or

4.       The research involves the use of the institution’s non-public information to identify or contact human research subjects or prospective subjects.

E.     Authority of the VCU IRB (including Western IRB, in operation as a VCU IRB):

Authority to Act on Proposed Studies:  The VCU IRB has the responsibility and authority to review all research projects involving human subjects before the involvement of human subjects may begin; require from investigators revisions in research protocols and informed consent documents as a condition for initial or continuing approval; approve new research projects and the continuation of previously approved projects; and disapprove the initiation of new research projects.  In addition, the VCU IRB has the responsibility and authority to review and take appropriate actions regarding conflict of interest issues.
 

Authority to Require Progress Reports and to Oversee the Study:  The VCU IRB has the responsibility and the authority to observe, or have a third party observe, the consent and the research. Furthermore, review progress of studies or monitor the activities in approved projects including regularly scheduled continuing review at least and to require verification of compliance with approved research protocols and informed consent procedures through means such as audit, observation or third party review. The authority to review progress of studies includes the authority to develop mechanisms for prompt reporting to the IRB of any planned changes in approved projects prior to the implementation of those changes and the authority to develop mechanisms for prompt reporting to the IRB of any unanticipated problems occurring in, or related to, approved protocols

Authority to Suspend or Terminate Approval of Research:  The VCU IRB has the responsibility and the authority to suspend or terminate approval of any study that it has originally reviewed and approved that has an unanticipated problem involving risks to human subjects, serious or continuing noncompliance with any federal regulation or serious or continuing noncompliance with the requirements or determinations of the IRB. Such actions will be determined at a convened meeting of the full panel with a quorum present and will be incorporated into the minutes of the meeting

Authority to Restrict a Research Activity:  Each IRB Panel has the responsibility and the authority to restrict any study that it has originally reviewed and approved if it determines to warrant such action.  If one aspect of a study fails to comply with federal regulations or IRB requirements or determinations, the panel must restrict the study so as to restrict the activity found in noncompliance until it is brought into compliance.   The panel may also request that a study audit be conducted by the OECO.

F.     Certain Non-Research Activities That Are Subject to IRB Review at VCU:

The following, highly specific activities qualify as human subject ’r;non-research activities’ that DO REQUIRE VCU IRB REVIEW.  Data from these activities must not be used for research purposes, however safety information may be collected and provided to the sponsor:

Data from emergency use of unapproved drugs or biologics MUST NOT be used for research purposes, however, safety information may be provided to the sponsor.

Non-Research Activities Involving Investigational Articles:  See XVI-5:  Non-Research (Treatment Use, Single Patient Use, Parallel Track Program)

Emergency Use of a Medical Device:  See XVII-3: XVII-3 Emergency Preparedness Plans Emergency Preparedness Plans

Emergency Use of a Drug or Biologic:  See XVI-4:  Emergency Use of an Investigational Drug or Biologic

RESPONSIBILITY:

It is the responsibility of the institution and all persons engaging in human research activities to abide by this policy.  It is the responsibility of VCU and its IRBs to ensure that full authority is exercised.

REFERENCES:

DHHS 45 CFR 46

FDA 21 CFR 50

FDA 21 CFR 56

OHRP Human Subject Research Decision Charts

OHRP Guidance Document:  Engagement of Institutions in Research

OHRP Guidance Document:  Coded Private Information or Biological Specimens