ORAL HISTORIES AND HUMAN
SUBJECTS RESEARCH
PROTECTION REQUIREMENTS
April 18, 2012
Objectives of Presentation


Better understand when oral histories are subject to
Federal human subjects protection requirements
Review of Tulane policies with regard to when oral
histories are subject to exempt or expedited review
The Challenge


Is ORAL HISTORY considered “research involving
human subjects”?
Who decides?
Why does it matter if oral history interviews
meet the definition of human subject research?


If not, then the activity is not subject to a myriad of
federal human subject protection regulations, which
Tulane is required to follow for all human subjects
research
If so, then the activity is subject to federal human
subject protection regulations and must undergo:
 Convened
review by Tulane’s IRB (i.e., full board
review),
 Exempt review, or
 Expedited review
2-Step process for review of oral histories


Step 1: Does the activity constitute human subjects
research; and
Step 2: If yes, does the research qualify for
exempt review or expedited review
Step 1
Regulatory Definition of “Research”

A decision whether oral history or other activities solely
consisting of open ended qualitative type interviews are
subject to the policies and regulations outlined in an
institution’s FWA and DHHS regulations for the protection of
human research subjects (45 CFR 46) is based on:


The prospective intent of the investigator; and
The definition of “research” under DHHS regulations at 45 CFR
46.102(d) as
A
“systematic investigation, including research
development, testing and evaluation, designed to
develop or contribute to generalizable knowledge.”
Lack of Guidance

Federal regulations do not provide a definition for:
 “systematic
investigation”
 “designed”
 “generalizable


knowledge”
The regulations fail to say who is to make that
determination
Such decisions are made on a case-by-case basis
depending upon the facts
Practical Interpretations


A “systematic investigation” is an activity that
involves a prospective research plan that
incorporates data collection, either quantitative or
qualitative, and data analysis to answer a research
question
“Generalizable knowledge” involves studies that are
designed to draw general conclusions (i.e.,
knowledge gained from a study may be applied to
populations outside the specific study population),
inform policy, or generalize findings
Human Subject Research Determination


The university has charged the IRB with monitoring all human subject
research occurring at the university. The PI is responsible for the initial
determination of whether the planned activity comprises human subjects
research (Tulane SOPs 3.3)
The sponsor and Tulane hold the PI accountable for wrong
determinations.



For this reason, PIs are strongly encouraged to request confirmation from
Tulane’s HRPO that the activity does not constitute human subjects research.
Requests to HRPO can be made via e-mail at irbmain@tulane.edu
REMINDER: The conduct of a research project without the appropriate
review is a violation of Tulane policy and Federal regulations and
subject to disciplinary action. Faculty and students should err on the
side of caution and contact the HRPO Office via e-mail at
irbmain@tulane.edu for guidance before commencing their research.
Why does it matter if human
subject research is involved?

Possible repercussions for failure to obtain IRB
approval of human subjects research:
 Prohibition
from using data;
 Prohibition from publishing;
 Reporting to federal oversight agencies (ex: FDA,
OHRP; OIG);
 Subject to filing of a research misconduct allegation,
which can lead to a range of penalties, including
expulsion.
What is oral history?





There is no Federal definition of “oral history”
Oral history activities in general are designed to create a record of
specific historical events and, as such, are not intended to contribute
to generalizable knowledge
Oral history narrators are not anonymous individuals selected as
part of a random sample for the purposes of a survey.
Interviewees are selected because of their personal relationship to
the topic under investigation. An oral history interview provides one
person’s unique perspective.
A series of oral history interviews offers up a number of particular,
individual perspectives on the topic, not information that may be
generalized to all participants in the event or time under
investigation.
What is oral history? (cont)



Oral history interviews are not analyzed as
qualitative data is generally analyzed.
No content analysis, discourse analysis, coding for
themes or other qualitative analysis methods of
data analysis are performed on the interviews.
They stand alone as unique perspectives.
It depends upon the facts &
investigator’s intent


It is primarily on the grounds that oral history
interviews, in general, are not systematic
investigations designed to contribute to
generalizable knowledge and are not subject to the
requirements of 45 CFR part 46 and, therefore, can
be excluded from IRB review.
However, some oral history interviewing projects
may meet the definition of research and will
require convened IRB review, expedited review, or
exempt review
General principles for evaluating oral
history type activities
Open Ended Interviews

Oral history activities, such as open ended
interviews, that ONLY document a specific historical
event or the experiences of individuals without an
intent to draw conclusions or generalize findings
would NOT constitute “research” as defined by
DHHS regulations 45 CFR part 46
Example 1:
Video Interviews


Question: Is an oral history video recording of
interviews with holocaust survivors created to preserve
or describe individual experiences to be viewed at the
Holocaust Museum considered “research” as defined by
DHHS?
Answer:
The creation of the video tape does NOT intend to draw
conclusions, inform policy, or generalize findings.
 The sole purpose is to create a historical record of specific
personal events and experiences related to the Holocaust
and provide a venue for Holocaust survivors to tell their
stories.
 Thus, no institutional review is required

Example 2: Open Ended Interviews to
Document Experiences & Draw Conclusions


Question: Is an oral history that involves interviews of Iraq
War Veterans that is intended to draw general conclusions
and otherwise learn about the impact of using National
Guard soldiers in a war considered “research” as defined by
DHHS?
Answer:


Yes, as it is designed to develop or contribute to generalizable
knowledge (e.g., designed to draw conclusions, inform policy, or
generalize findings) and WOULD constitute “research” as defined
by DHHS regulations at 45 CFR part 46
Yes, needs review. The investigator would have to submit an initial
application to the IRB for either convened, exempt or expedited
review
Example 3:
Interviews for Publications


Question: Does interviewing prisoners for a
magazine article on prison life constitute human
subjects research?
Answer:
 No.
The goal is not the production of generalizable or
universal knowledge. Rather, the information generated
is specific to the people interviewed in their current
situation.
 Thus, no institutional review is required
Example 4:
Oral Histories for Archival Purposes


Question: Whether open ended interviews conducted with
surviving Negro League Baseball players intended to create
an archive for future research constitutes research?
Answer:



Yes. The creation of such an archive would constitute research
under 45 CFR part 46 since the intent is to collect data for future
research.
Since the intent of the archive is to create a repository of
information for other investigators to conduct research as defined
by 45 CFR part 46, the creation of such an archive WOULD
constitute research under 45 CFR part 46.
The investigator would have to submit an initial application to the
IRB for either convened, exempt or expedited review
What is exempt research?



Minimal risk studies that fall within set categories listed in Tulane SOPs
3.4.2. with a shortened IRB application.
While exempt research is human subject research requiring institutional
review, it does not require convened (i.e., full) IRB review. Such review is
typically approved by the IRB chair (or designee)
One category of exempt research potentially applicable to oral histories is
research involving the use of educational tests, survey procedures, interview
procedures, or observation of public behavior, unless:




Information obtained is recorded in such a manner that Human Subjects can be identified
directly or through identifiers linked to the subjects; and
Any disclosure of the Human Subjects responses outside the research could reasonably
place the subjects at risk
Exempt research can never include research involving children, prisoners or
that is international in nature [Tulane SOPs 3.4.1]
If planned oral research is not exempt, consider whether it qualifies for
expedited review
What is expedited research?




Requires one or more experienced IRB reviewers,
but does not require a convened IRB [see Tulane
SOPs 3.5]
There must be no more than minimal risk to subjects.
The identification of participants will not place them
at risk of criminal or civil liability or be otherwise
damaging
Review is conducted by the IRB Chair or designee
and approval period is for up to one year.
Categories of expedited research

The research must fit into one of several specific
categories enumerated in Tulane SOP 3.5.1to qualify
as expedited research. Common categories include:

Category 6


Category 7


Collection of data from voice, video, digital, or image recordings
made for research purposes
Research on individual or group characteristics or behavior
(including research on perception, cognition, motivation, identify,
language, cultural beliefs, social behavior, etc.)
If planned oral research does not qualify for exempt or
expedited review, then it must go to full board review.
Summary

If you wish to avoid triggering federal human subjects
research protection regulations, try to structure activity to
avoid definition of human subjects research, which would
eliminate the need for IRB review

Alternatively, meet the definition of exempt review


Alternatively, fit research into an expedited review category


Benefits: shortened initial application, may be granted up to 3 years
exempt IRB approval, and review by IRB chair (or designee) rather
than full board
Benefits: review by IRB chair (or designee) rather than full board
review
If you have questions, please contact Tulane’s Office of
Human Research Protection (HRPO) at 504-988-2665 or by
E-mail at irbmain@tulane.edu