The
NIU research community has recently become aware of reports that the Department
of Health and Human Services-Office for Human Research Protections (DHHS-OHRP)
may have changed their guidance regarding Oral History types of research. The
NIU Office of Research Compliance (ORC) contacted Dr. Michael Carome, DHHS-OHRP
Associate Director for Regulatory Affairs, to discuss the reports and seek his
guidance for education of the NIU research community and our IRBs regarding the
reports and their impact on qualitative research utilizing open-ended
interviews, especially activities performed by oral historians and other social
scientists.
The discussion confirmed that communication between OHRP and the Oral History
community does not change the DHHS interpretation of the
Federal regulations for the protection of human subjects nor does it change NIU
policy on such research.
The following information, confirmed by Dr. Carome, clarifies the reports and
his September 22, 2003 letter to Ms. Linda Shopes, Pennsylvania Historical and
Museum Commission and Mr. Donald Ritchie, Senate Historical Office. Included are helpful examples and general
principles for evaluation of such research.
More
formal guidance from OHRP is expected in 2004.
>>>E-mail message from Michael
Carome <MCarome@OSOPHS.DHHS.GOV>
12/01/03 9:23 AM
Dear Ms. Bross,
Thank you for your thoughtful comments regarding oral history activities. Dr. Schwetz has asked me to respond to you
on behalf the Office for Human Research Protections (OHRP).
As you are aware, representatives of oral history organizations earlier this
year asked OHRP to review a policy statement that they had drafted regarding
the relationship between research (as defined by the Department of Health and
Human Services (HHS) regulations at 45 CFR 46.102(d)) and oral history
activities. They also asked whether OHRP agreed with the content of their
draft policy.
OHRP responded to the oral historians with a letter stating OHRP's concurrence
with the draft policy statement that oral history activities in general do not
involve research as defined by the HHS regulations and providing some suggested
edits. I have attached a pdf file containing a
copy of OHRP's letter below. Please note that the inclusion of the words
"in general" in OHRP's response means that certain human subjects
research activities may include oral history activities, and such research
activities should be reviewed by an institutional review board (IRB) unless the
research is exempt under HHS regulations at 45 CFR 46.101(b). Indeed, in its
September 22 letter, OHRP noted that on occasion, investigators conducting
human subjects research as defined by the HHS regulations may use oral history
interviewing procedures. Unless such research is exempt under HHS
regulations at 45 CFR 46.101(b), IRB review would be required if the research
is conducted or supported by HHS or conducted under an applicable OHRP-approved
assurance.
Based upon comments that we have received since OHRP's letter regarding oral
history activities was issued, it appears that many institutions and IRBs took
the position that oral histories always involve research. Based upon the
nature of oral histories, OHRP does not agree with such a position. As articulated in OHRP's letter, OHRP has
taken the position that the activity of performing an oral history in and of
itself does not make the activity research as defined by 45 CFR
46.102(d). OHRP could have issues a similar statement about many
activities. For example, OHRP could have stated that activities that
involve taking a medical history, a blood draw for serum chemistries, a chest
x-ray, or a CT scan of the head in general do not involve human subjects
research; however, when investigators conducting non-exempt human subjects
research use such procedures, the research must be reviewed by an IRB if the
research is conducted or supported by HHS or conducted under an applicable
OHRP-approved assurance.
Some commenters have suggested that because oral history appears on the list of
research activities that may be reviewed by the IRB under an expedited
procedure, oral history activities must be research. In response, OHRP has
noted that that the fact that an activity, such as oral history, appears on the
list of activities that may be reviewed by an IRB through an expedited review
procedure does not mean that such an activity always involves research.
For example, collection of blood samples; weighing or testing sensory
acuity; magnetic resonance imaging; electrocardiography,
electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging,
doppler blood flow, and echocardiography; moderate exercise, muscular
strength testing, body composition assessment, and flexibility testing are also
on the expedited review category list; however, the use of these procedures
most commonly occurs outside the research context.
Some commenters have suggested that OHRP's comments regarding oral history
activities can be extrapolated to all activities that involve open-ended,
qualitative interviews. In response, OHRP has noted that its position
regarding oral history was not based upon the fact that oral history activities
involve open-ended, qualitative interviews of a nonrandom sample of
individuals. Other activities involving open-ended interview that have
characteristics similar to oral histories can involve research as defined by
HHS regulations when the activities are part of a systematic investigation
designed to develop or contribute to generalizable knowledge.
Finally, below is the content of an email that summarizes OHRP's discussion
with officials at another institution about oral history activities that may
provide you with some additional helpful information:
____________________________________________________________
History:
Issues regarding oral history and human subjects research date back to the
National Commission and most recently emerged with NBAC, NHRPAC, and a letter
from oral historians to OHRP.
The 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 HHS 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 HHS regulations
at 45 CFR 46.102(d): "a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute
to generalizable knowledge."
Specifically, for the purposes of our discussion, the evaluation of such
activities hinges upon whether the person is engaged in the creation of
"generalizable knowledge" that is, whether the activity represents a
systematic investigation in which the person engaged in such activities intends
to develop or contribute to generalizable knowledge. However, 45 CFR 46
does not provide a definition of "generalizable knowledge".
Oral history activities, as described to OHRP by the oral history
representatives, in general are designed to create a record of specific
historical events and, as such, are not intended to contribute to generalizable
knowledge.
General principles for evaluating Oral History type activities:
1. 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 HHS regulations 45 CFR part 46.
Example: An
oral history video recording of interviews with holocaust survivors is created
for viewing in the Holocaust Museum. 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.
2. Systematic investigations involving open-ended interviews that are
designed to develop or contribute to generalizable knowledge (e.g., designed to
draw conclusions, inform policy, or generalize findings) WOULD constitute
"research" as defined by HHS regulations at 45 CFR part 46.
Example: An
open ended interview of surviving Gulf War veterans to document their
experiences and to draw conclusions about their experiences, inform policy, or
generalize findings.
3. Oral historians and qualitative investigators may want to create
archives for the purpose of providing a resource for others to do
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.
Example:
Open ended interviews are conducted with surviving Negro League Baseball
players in order to create an archive for future research. The creation
of such an archive would constitute research under 45 CFR part 46 since the
intent is to collect data for future research.
An institution should perform an initial two step evaluation prior to deciding
whether an activity constitutes human subject research:
a. determine whether the activity constitutes
"research" as defined by 45 CFR 46.102(d), and
b. determine whether the "research"
includes human subjects as defined by 45 CFR 46.102(f).
In summary, the August 26, 2003 Policy Statement attached to OHRP's September
22, 2003 letter was not drafted by OHRP, does not constitute OHRP guidance, and
the characterizations of oral history activities in the third paragraph of the
Policy Statement alone do not provide sufficient basis for OHRP's determination
that oral history activities in general do not involve research as defined by
HHS regulations at 45 CFR part 46. Other activities involving open-ended
interview that have similar characteristics can involve research as defined by
the HHS regulations when the activities are part of a systematic investigation
designed to develop or contribute to generalizable
knowledge.
____________________________________________________________
I hope this information is helpful. Please feel free to contact me if you
would like to discuss this matter further.
Mike
Michael A. Carome, M.D.
Associate Director for Regulatory Affairs
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Tel: 301-402-5567
Fax: 301-402-2071
email: mcarome@osophs.dhhs.gov