Source: https://policy.vcu.edu/universitywide-policies/policies/conduct-of-human-subjects-research.html
Timestamp: 2019-08-25 06:44:12
Document Index: 69161133

Matched Legal Cases: ['art 46', 'art 50', 'art 56', 'art 812', 'art 312', 'art 812']

Policies - Conduct of Human Subjects Research - Virginia Commonwealth University
Conduct of Human Subjects Research
Current Approved Version: 04/18/2019
Human subjects research at Virginia Commonwealth University and the Virginia Commonwealth University Health System Authority, hereafter collectively referred to as "VCU," must be carried out in accordance with applicable laws, regulations, and the highest ethical standards. As applicable, human subject research must be conducted in compliance with the following federal regulations: 45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, and 21 CFR 54.
VCU authority to conduct human subjects research is granted by a Federalwide Assurance (FWA) with the Department of Health and Human Services' Office for Human Research Protections (DHHS/OHRP). VCU’s FWA number is FWA00005287.
The VCU FWA, as signed by the vice president for research and innovation of the university, requires prior Institutional Review Board (IRB) approval of all human subjects research, including research that may qualify as exempt, if the activity:
Is sponsored by VCU, or
Is conducted by or under the direction of any employee or agent of VCU in connection with their institutional responsibilities, or
Is conducted by or under the direction of any employee or agent of VCU using any property or facility of VCU.
Some non-research activities may require IRB approval, such as expanded access uses (FDA 21 CFR 312 Subpart I) and emergency use (FDA 21 CFR 56.102(d), 56.104, and 312.36) of investigational drugs or devices.
All individuals involved in human subjects research are responsible for knowing this policy and familiarizing themselves with its contents and provisions.
Any experiment that 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 (FDA) under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. [21 CFR 50.3]
A type of a clinical research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
According to the Common Rule [45 CFR 46.102(e)] a "human subject" is a living individual about whom an investigator (whether professional or student) conducting research
Obtains information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or
For purposes of research regulated by the Food and Drug Administration, “human subject: means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control; a subject may be either a healthy individual or a patient [21 CFR 50.3(g)].
Activities that meet the definition of both "human subjects" and "research," “human subjects” and “clinical investigation,” or “human subjects” and “clinical trial” are considered human subjects research.
A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]
Federal departments or agencies implementing 45 CFR 46 as the “Common Rule” as revised in 2018, will revisit the definition of “identifiable private information” and “identifiable biospecimen” as defined here within one year of implementation of the revised rule and at least every four years thereafter.
Private information for which the identity of the subject is or may readily be ascertained by the investigator associated with the information. [45 CFR 46.102(e)(5)].
Interaction includes communication or interpersonal contact between investigator and subject. [45 CFR 46.102(e)(3)
Both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. [45 CFR 46.102(e)(2)
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [45 CFR 46.102(j)]
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 (for example, a medical record). [45 CFR 46.102(e)(4)]
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities [45 CFR 46.102(l)]. For purposes of this policy, the following activities are deemed not to be research:
The Office of Human Research Protection Program officially interprets this policy. The Office of Human Research Protection Program is responsible for obtaining approval for any revisions as required by the policy Creating and Maintaining Policies and Procedures through the appropriate governance structures. Please direct policy questions to the Office of Human Research Protection Program.
Effective January 19, 2019, all human subjects research, clinical investigations, or clinical trials must be approved by a VCU IRB or a VCU-approved external IRB before the research may begin. IRB approval is specific to each human subjects research proposal, clinical investigation, or clinical trial. Protocols established by an IRB review may not be used to conduct a different human subjects research study, clinical investigation, or clinical trial (hereafter: research or research studies) without the prospective approval of VCU IRB.
Prior to commencing research, all research studies must be submitted for review through the RAMS-IRB electronic system for review according to one of the following procedures:
1. Full IRB Review by the VCU IRB
Full IRB review is conducted by the full board at a convened IRB panel meeting. Research that is greater than minimal risk to human subjects and/or does not qualify for one of the other review types listed below must be reviewed by the full board. Research approved by the full board is subject to continuing review by the IRB at least annually. Proposed changes to approved research must be approved by the IRB prior to implementation.
2. Expedited IRB Review by the VCU IRB
An expedited review may be conducted by a single IRB member. Research is eligible for expedited review when there is no more than minimal risk to human subjects and when the research activity falls into one of nine categories identified in the Federal Register (The Secretary of HHS will evaluate the list every 8 years and amend as appropriate after consultation with other federal departments and agencies. [45 CFR 46.110(A)]). Research determined to not qualify for expedited review requires full IRB review. Research approved by the expedited procedure is not subject to the requirements for continuing review unless the IRB determines and documents otherwise. Proposed changes to approved research must be approved by the IRB prior to implementation.
3. Exempt Review by the VCU IRB
Research that qualifies for exempt review is no greater than minimal risk to human subjects and the study procedures fall into one of eight categories identified in the federal regulations. Exemption determinations are made by a single IRB member. Once determined to be exempt, proposed modifications to the research that would change the type of review (e.g., research no longer qualifies for exemption), must be submitted for review and approval prior to implementation.
Certain research within the eight categories identified in the federal regulations as exempt are designated by the federal regulations as requiring “limited IRB review.” Review by a single IRB member satisfies this additional requirement.
Assistance with IRB submissions may be obtained from the VCU Human Research Protection Program or at the IRB webpage.
Submission of new research studies for IRB review and approval must be done electronically in the RAMS- IRB system. Templates and remaining supplemental paper forms may be obtained on the Office of Research and Innovation website.
Current IRB Forms
Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46)
Title 21, Part 50 of the Code of Federal Regulations (50 CFR 50)
Title 21, Part 56 of the Code of Federal Regulations (50 CFR 56)
Title 21, Part 812 of the Code of Federal Regulations (21 CFR 812)
Title 21, Part 312 of the Code of Federal Regulations (21 CFR 312)
VCU IRB Written Policies and Procedures
VCU Human Research Website
02/05/2015 Conduct of Human Subjects Research
04/09/2018 Conduct of Human Subjects Research
02/11/2019 Conduct of Human Subjects Research-Interim
1. What categories of research may be exempt?
As stated in the “Exempt Review by the VCU IRB” section of the policy above, exemption determinations are made by a single IRB member.
In accordance with the federal regulations, and unless otherwise required by law, or by department or agency heads, or unless precluded by 45 CFR 46.104(b) the following categories of research may be exempt after January 19, 2019:
Categories of Exemption [45 CFR 46.104(d)]
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act as amended.
Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by 45 CFR 46.111(a)(8).
Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1) through (4), (a)(6), and (d);
Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;
An IRB conducts a limited IRB review and makes the determination required by 45 CFR 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
2. What kinds of research activities qualify for expedited review?
The following research activities are listed in the federal regulations as qualifying for expedited review:
Categories For Expedited Review:
HHS 45 CFR 46.110
an investigational device exemption application (21 CFR Part 812) is not required; or
from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more
frequently than 2 times per week.