Humanities and Oral History Projects
and the IRB
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- What projects require IRB Review?
- What constitutes "research" in the regulations?
- What constitutes a "human subject" in the regulations?
- Do Humanities Projects Require IRB Review?
- What is "Oral History"?
- Do Oral History Projects Require IRB Review?
- When are humanities or oral history projects considered to be human subject research requiring IRB review?
- What if it is unclear if the project falls within the scope of the IRB?
- What must be submitted for IRB review?
- What if the interview questions will differ for each participant?
- Consent vs. Publication Release Forms
- Will the IRB require that the data be made anonymous?
What projects require IRB
Review?
The IRB is charged with reviewing projects
which are “research” and which involve “human subjects” as defined
in the federal regulations at
45 CFR 46. Note that the determination of whether or not a
project involves human subjects is separate from whether or not the
project constitutes research and only when both regulatory
definitions are met does the study require IRB review.
What constitutes “research” in the
regulations?
Research is defined as “a systematic
investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable
knowledge” (45
CFR 46.102(d)).
Under this definition, the project must
intend at the outset to generate conclusions which can be applied in
or be predictive of similar circumstances. Thus a case study of a
single individual would not be considered research if the case
study’s analysis relates to the individual rather than classes of
similar like individuals. In contrast, a study of a single event
involving interviews of the relevant parties, whether or not they
all respond to the same set of questions, but which intends to
analyze the responses to reach conclusions on how people in general
react to such an event would be research.
What constitutes a “human subject” in the
regulations?
A human subject is defined as 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) obtains identifiable
private information” (45
CFR 46.102(f)).
Under this definition, the data must be
collected about a living person and the data is either collected
directly from that person or the data would be considered to be
private information about that person. Information collected without
interacting with the individual or without any identifiers or other
details which could lead to identification of an individual would
not be considered to involve human subjects. Information which
involves interaction with an individual but which does not collect
information about a person, such as interviews on government or
corporate policies or historical events are also not considered to
involve human subjects. Such interviews would include human subjects
if the questions were to turn to issues of an individuals’
involvement in such matters or of their opinions and compliance with
these issues.
Do Humanities Projects Require IRB Review?
Sometimes. The majority of humanities
projects do not require review by the IRB. While these projects are
clearly scholarly work, they do not always meet the regulatory
definitions of research. There are, however, cases where the project
would fall under the purview of the IRB. Studies which qualify as
“research” and which involve “human subjects,” as defined in the
federal regulations, would require IRB review under New College
policy.
What is
“Oral History”?
The Oral History Association defines oral
history as, “…a field of study and a method of gathering, preserving
and interpreting the voices and memories of people, communities, and
participants in past events.” (http://alpha.dickinson.edu/oha/about.html)
Do Oral History Projects Require IRB
Review?
Sometimes. The determination as to whether
or not a project requires IRB review is determined based on whether
or not the project meets the federal definition of research as
described above. Those projects which do not meet this definition do
not need to be submitted to the IRB for review.
In 2003, the
American Historical Association and the
Oral History Association, developed a statement on the
applicability of the regulations on the protection of human subjects
(45CFR 46, Subpart A) with which the Office of Human Research
Protections within the Department of Health and Human Services
concurred. The relevant statement is that: “Most oral history
interviewing projects are not subject to the requirements of the
Department of Health and Human Services (HHS) regulations for the
protection of human subjects at 45 CFR part 46, subpart A, and can
be excluded from institutional review board (IRB) oversight because
they do not involve research as defined by the HHS regulations.” A
careful review of the project in relation to the federal definition
provided above is needed to determine whether or not a given project
should be submitted to the IRB.
The Oral History Association developed a
pamphlet on oral history evaluation guidelines and principal of
conduct. The NCF IRB strongly recommends review of the following
site prior to designing your project and interviewing participants:
http://alpha.dickinson.edu/oha/pub_eg.html.
When are humanities or oral history
projects considered to be human subject research requiring IRB
review?
If the proposed project will involve
analyzing data to reach conclusions, inform policy or generalize
finding AND that data is either identifiable private information
about a living individual OR collected directly from the individual
about him or herself, then the project should be submitted to the
IRB.
For example, the following may be
indicators that IRB review is required:
·
The study is funded by an
agency which seeks to support projects designed to create
generalizeable knowledge such as U.S. Department of Health and Human
Services, National Science Foundation, U.S. Department of Education
(including the Fulbright program) etc.
·
The study will involve
multiple individuals’ perspectives on the issue of interest AND
these perspectives will be analyzed to reach generalized
conclusions.
The following examples are projects which
would NOT require IRB review:
·
The goals of the project are
to document a specific issue or event or the experiences of
individuals and will not be used for further analysis for
commonalities predictive of future instances
·
The project will compare and
contrast policies, procedures or events to identify general
commonalities or inform policy decisions without collection of
information about identified individuals.
What if it is unclear if the project falls
within the scope of the IRB?
The IRB can provide assistance in
determining if a given project must be reviewed under New College
policy. This is most commonly done through a phone call (487-4649)
or e-mail (irb@ncf.edu)
to the Board providing a brief description of the nature of the
project.
What must be submitted for IRB review?
Detailed information is available on the
IRB web site (www.ncf.edu/orps/compliance/compliance.htm)
including an application form and checklist. In general,
applications include the application cover page and a description of
the study including the goals of the study, the type of information
to be collected, who will be the subject of the research, and what
information will be provided to the participants to obtain their
agreement to be interviewed. Please note that the checklist included
with the application instructions is intended to cover various human
subjects research projects and the items listed may not all be
applicable to a given project.
What if the interview questions will
differ for each participant?
Although each participant will have his or
her own unique area of expertise to lend the project, the goals of
the project define the general areas to be covered in the interviews
and this can usually be defined broadly if not by specific
questions. In some cases the populations to be interviewed can be
categorized and the information to be gained from each group can be
described. For example, a project on the effectiveness of a public
policy may be parsed into interviews with government officials on
the reasons for the policy and how it is enforced, and interviews
with the public stakeholders regarding their reaction to the policy
and their adherence to it.
Consent vs. Publication Release Forms
Consent refers to obtaining the
interviewee’s agreement to be interviewed and usually involves
explaining the nature of the interview and what will be done with
the information. Depending on the depth of the interview and the
sensitivity of the questions, the consent information may or may not
be written up as a form which also may or may not involve signature
by the interviewee.
Release forms are used to obtain the
interviewee’s permission to quote the interviewee in publications
and serve to notify the interviewee that they will not retain rights
or control in the final dissemination of the interview. Unlike
consent which can be obtained without a signed form under
appropriate circumstances, release forms are required to be signed
if transcripts will be published verbatim or if video testimonies
will be shown publicly.
Will the IRB require that the data be made
anonymous?
There is no IRB requirement that the
information be anonymous. The IRB does require that the participants
be made aware of whether or not their names will be associated with
their responses and any inherent risks associated with such
disclosure. Many humanities projects do not intend to keep the
identity of the interviewees confidential let alone anonymous. In
fact it is not uncommon for the interviewees to want to have their
name associated with their responses. Maintaining identified data is
allowable by the IRB. Projects that pose significant risk to the
participants from disclosing their responses without a
counterbalancing benefit anticipated from the project, however,
would be considered unethical.
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