Human Research Protection Program: Policy

Defining Human Subjects Research

Adopted By: All Campus IRB

Adoption Date: August 4, 2005

Revised: June 7, 2007

Revised: May 1, 2008

Revised: December 4, 2008

Revised: September 10, 2009

 

Purpose:  These policies and procedures describe how UW-Madison IRBs determine when activities meet the regulatory definition of “human subjects research” that is subject to UW-Madison’s Human Research Protection Program (HRPP).

Policy

I.      UW-Madison’s HRPP applies to all human subjects research conducted under the jurisdiction of the UW-Madison.  To determine whether the activity is subject to UW-Madison’s HRPP, three questions must be answered:

 

·         Is the activity “research?”

 

·         Does it involve “human subjects?”

 

·         Is it under the jurisdiction of the UW-Madison?

II.     Defining “Research”

A.  Under the federal Common Rule, “research” is defined as "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 which is considered research for other purposes. For example, some demonstration and service programs may include research activities. [45 CFR 46.102(d)]

B.  Under the FDA regulations, the terms research, clinical research, clinical study, study, and clinical investigation are synonymous. [21 CFR 56.102(c)].  Under FDA regulations activities are “research” when they involve:

 

1.  Use of a drug other than the use of an approved drug (approved by the FDA for marketing) in the course of medical practice [21 CFR 312.3(b)]

 

2.  Use of a medical device other than the use of an approved medical device (approved by the FDA for marketing) in the course of medical practice [Food, Drug and Cosmetic Act 530(g)(3)(a)(i)]

 

3.  Gathering data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product. [21 CFR 50.1(a) or 56.101(a)]

 

Examples of “research” activities:

 

·         Formal investigations

·         Pilot projects

·         Exploratory studies

·         Student independent studies, theses, or dissertations

·         Some demonstration activities

·         Some service programs

 

Examples of activities that are generally NOT “research:”

 

·         Classroom activities that teach research methodologies or simulate research activities

·         Activities conducted to improve the quality of teaching in a particular classroom

·         Activities required for quality assessment (QA) or quality improvement (QI)

III.    Defining “Human Subjects”

A.  Under the Common Rule, a “human subject” is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]

 

·         "Intervention” includes both physical procedures by which data 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(f)]

 

·         "Interaction” includes communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]

 

·         "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 (for example, a medical record). 

 

·         “Private information” must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. [45 CFR 46.102(f)]

B.  Under FDA regulations, “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. [21 CFR 50.3(g), 56.103(e), 312.3(b)].  If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control [21 CFR 812.3(p)]  A subject may be either a healthy human or a patient. [21 CFR 56.102(e)]

 

Examples of activities that qualify as “human subjects research” needing IRB review include:

 

·         Human testing of drugs, devices, or products developed through research.

 

·         Research using data collected through intervention or interaction with living individuals:

 

o        Intervention includes not only physical procedures (like blood drawing), but also manipulation of the subject’s environment.

o        Interaction includes interpersonal contact, surveys, and other forms of communication.

 

·         Research involving information collected for purposes other than the research being conducted (e.g. medical, school or correction records).

 

·         Research involving identifiable bodily materials such as human cells, blood or urine, tissue, organs, hair, and nail clippings, even if they were not collected by the person using the materials for the research.

 

·         Accessing medical records and data through the medical information systems, for research purposes.

 

·         Extraction of individually identifiable information from medical records, for research purposes.

 

·         Establishment of a tissue bank or databank that includes individually identifiable data from living individuals.

 

·         Case studies in social science research.

 

Examples of activities that are not “human subjects research” at the UW-Madison include:

 

·         Research projects involving certain publicly available data sets pre-approved by the UW–Madison IRBs.  An investigator may submit information on potentially eligible data sets to the IRB office prior to conducting research.  See, Existing Datasets Policy to determine when publicly-available social science datasets may be used without prior IRB approval.

 

·         Proposals for Protocol Development Activities Only and Umbrella Protocols are not considered by UW-Madison IRBs to be research involving “human subjects” and are processed by the IRB Office using an administrative review procedure. See, Application for Protocol Development Activities Only Guidance.

 

·         Research that solely involves information about or specimens collected from decedents.

 

·         Preparation and publication of a medical case report that includes information from 3 or fewer individuals.

 

·         Activity involving use of anonymized or coded tissue or specimens obtained from a data repository and for which the investigator has no access to a code or link to re-identify the source of the tissue or specimen.

 

·         Activity involving cell lines derived from humans obtained from a commercial source and for which the investigator has no access to a code or link to re-identify the source of the cell lines.

IV.   Defining UW-Madison’s Jurisdiction

A.  Whenever UW-Madison “engages” in human subject research, the research must be reviewed and approved by a UW-Madison IRB before it can begin.  However, a UW-Madison IRB may choose to delegate IRB review to another institution’s IRB or agree to act as the IRB of record for another institution’s protocol.  See, IRB Authorization Agreements Policy.

B.  UW-Madison “engages” in human subject research when:

 

1.  any of UW-Madison’s employees (including faculty, staff, students, or fellows) or agents conducts human subjects research.  “Agents” include all individuals performing institutionally designated activities (including students) or exercising institutionally delegated authority or responsibility.

 

2.  investigators unaffiliated with UW-Madison use any UW-Madison resource, property or facility to conduct human subjects research;

 

3.  UW-Madison receives a federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor or collaborator;

 

This includes all human subjects research that is (a) sponsored by any of the institutions included under the UW-Madison designation, including UW-Madison and the Wisconsin State Laboratory of Hygiene; (b) involves the use of non-public information maintained by UW-Madison; and (c) conducted in accordance with an Assurance filed with OHRP in which UW-Madison is designated as the IRB of record.

C.  Projects Involving Subgrants or Other Agreements

 

1.  University is the Grantee: The University is responsible for all projects, regardless of performance site, for which the University is the prime grantee. All subgrantees at which human research activities are involved must have protocol approval and have completed the required training in the protection of human research participants. If a training program is not available to the subgrantee, UW-Madison Office of Research and Sponsored Programs (RSP) will work with the subgrantee to ensure satisfaction of the UW-Madison educational requirements. The subgrantee may complete UW-Madison’s on-line CITI Human Subjects Protection Training.

 

2.  University is the Subgrantee: The University is responsible for all activities taking place on its campus and for all activities performed by its employees within the scope of their duties. Therefore, even if the University is not the prime grantee, IRB approval of the protocol and certification of completion of human subjects training is necessary. However, in limited circumstances, a UW-Madison IRB may choose to delegate IRB review and approval to another institution’s IRB. For more information, see, UW-Madison’s IRB Authorization Agreement Policy.

D.  Investigators at the William S. Middleton Veterans Administration (VA) Hospital are covered by the UW-Madison FWA through an IRB Authorization Agreement and a Memorandum of Understanding between UW-Madison and the Middleton VA Hospital.

E.  Investigators at the University of Wisconsin Hospital and Clinics (UWHC) are covered by the UW-Madison FWA through and IRB Authorization Agreement and a Memorandum of Understanding between UW-Madison and the University of Wisconsin Hospital and Clinics Authority (UWHCA).

F.  UW-Madison does not “engage” in human subject research when an individual with a minimal percentage UW-Madison appointment (e.g. 0% to 25%) conducts human subject research in his or her role as an employee of a non-UW-Madison entity or institution.  Such individual may not refer to their UW-Madison affiliation in any grant applications, publications, or other oral or written material, including any material presented in a public forum, related to the research; and the research may not be conducted using any UW-Madison resource, property or facility.  Additionally, such individual should take reasonable efforts to ensure that he or she is not improperly associated with the UW-Madison by a third-party in any of the materials identified above.

 

Procedure

V.    Determinations of whether a planned activity is human subjects research can be made by the full IRB, an IRB subcommittee, or an experienced IRB member, depending upon, among other factors, the timing of submission of the application, the workload of the IRB, the expertise required to review the proposal, and the potential sensitivity of the application.  Determinations are made on a first-come, first-served basis.

VI.   The issue of whether a planned activity is human subjects research needing IRB review may arise as the result of the submission of a protocol application or as a result of an informal inquiry to the IRB office by an investigator. 

A.  If the issue arises as a result of the submission of a protocol application, the determination on the issue is made based on the protocol filing and documented in an electronic database and a paper file, and the investigator is notified of the determination by phone, email or letter.

 

1.  When the Health Sciences IRBs Office receives a request from a project sponsor or other entity to make a formal determination regarding whether a project includes human subjects or constitutes research and whether a project requires ongoing IRB review, the person making the request is required to submit an Application for Exemption from IRB Review so that the IRB reviewer may obtain sufficient information to make the determination regarding whether the project constitutes research or research that involves human subjects.  If a formal application is made, the Health Sciences IRB Office provides a formal determination letter.

B.  If an informal inquiry is made, the IRB office will ask the investigator questions about the research goals and methods and the involvement of human subjects or identifiable information.

 

1.  If the IRB office believes that the activity is not human subjects research, the office may orally inform the investigator. 

 

2.  If the IRB office determines that the activity is human subjects research or if it is unclear whether the proposed research qualifies as human subjects research, the IRB office will request that the investigator submit a protocol application for review by the IRB office.

VII.   At the UW-Madison, some activities routinely raise the issue whether the activities constitute “human subjects research:”

A.  For the following activities, the HS IRBs asks the person planning to conduct the activities to submit an exemption application that the IRB office can review to determine whether the activity constitutes “research” or involves “human subjects:”

·   Quality assurance/quality improvement activities that may be published

·   Program evaluation activities that may be published

·   Use of identifiable cell lines derived from humans

·   Use of de-identified samples or data derived from humans

·   Use of coded samples or data derived from humans

B.      The SBS IRB and ED IRB offices refer students calling with questions about graduate student research projects to the Student Research Policy.

C.      Research projects involving certain publicly available data sets may not need prior approval by the UW–Madison IRBs.  An investigator may submit information to the IRB office prior to conducting research on datasets potentially eligible for pre-approval by the IRB.  See, Existing Datasets Policy. 

VIII.  Proposals for Protocol Development Activities Only and Umbrella Protocols are processed by the IRB Office using an administrative review procedure.  See, Application for Protocol Development Activities Only Guidance.