On October 16, 2001, a statement
was published in Almanac (http://www.upenn.edu/almanac/v48/n08/OR-HumanSubj.html)
setting down guidelines for Institutional Review Board (IRB) review
of research in the social and behavioral sciences.
As promised in that statement, we
commissioned a Working Group "to propose guidelines for the
ethical use of human subjects in sociobehavioral research at the
University of Pennsylvania". The Working Group has now submitted
their report titled "Report of the Working Group on Human
Subjects Research in the Sociobehavioral Sciences" which
is published below.
The report contains a number of recommendations;
we shall be reviewing them and undertaking to implement many of
them in the course of the next year. Comments on the report may
be sent via e-mail by September 24, 2002 to firstname.lastname@example.org.
Nathanson, Vice Provost for Research
-- Mitchell Marcus, Chair,
the Working Group on Human Subjects Research in the SocioBehavioral
policies, based on agreements with the Federal government, require
that all research involving human subjects be subject to review
by our Institutional Review Board [IRB] system. Under the Federal
government's regulations at 45 CFR 46, research is defined
as "a systematic investigation including research development,
testing and evaluation, designed to develop or contribute to generalizable
for IRB review extends to research conducted by faculty, staff,
research fellows, and students, whether funded or unfunded. While
researchers in bio-medical sciences have long been accustomed
to human subjects review procedures, many social and behavioral
researchers have not previously been aware of, nor held to these
In response to
the questions of policy and implementation raised by the application
of human subjects review procedures to the sociobehavioral sciences,
in Fall 2001 the Vice Provost for Research and the Chair of the
Faculty Senate appointed a working group comprised of University
faculty drawn from several different schools and departments who
represent the variety of social and behavioral disciplines across
the University. The Working Group was charged to consider principles
that guide the ethical conduct of behavioral and social science
research on human subjects, and to offer recommendations for improvements
in the human subjects review policies and practices at the University.
Foremost in our
discussions was the recognition that compliance with University
and federal rules requires the efficient processing of reviews.
The University can not expect researchers to cooperate with the
review system if it can not perform in a timely and appropriate
manner. Efforts in this direction are ongoing, and have already
resulted in the establishment of an IRB devoted to social and
behavioral research. In addition, the IRB has developed a streamlined
procedure for processing and approving exempt research. A new
form for requesting exemption of a research project has been posted
to the Office of Regulatory Affairs (ORA) web site along with
a diagram of what constitutes an exempt study. Still, further
steps need to be taken if the process of applying for and receiving
IRB approval is to be truly efficient.
we believe that the community of sociobehavioral researchers at
the University and throughout the country are at the early stages
of a fundamental shift in our approach to human subjects research.
Many of us were educated and began our research careers at a time
when these issues were neither explicitly addressed nor formally
imposed on our professional practices. We must take steps to incorporate
the evolving principles of ethical research practice in our teaching
and our research. Over time, as future cohorts of researchers
are trained to incorporate these principles and procedures into
their practices the role of the IRB system will become both more
widely understood and less burdensome on researchers and on IRB
As the Working
Group proceeded to consider various domains of sociobehavioral
research several themes emerged that led to a set of analyses
and recommendations. Chief among these are an emphasis on the
importance of instituting educational efforts that would bring
current as well as future researchers into fuller awareness of
the issues surrounding the ethical use of human subjects in sociobehavioral
research. As will be explicated below, we are in favor of the
development and implementation of web-based tutorial and certification
systems analogous to those now mandated by the Federal government
for researchers funded by NIH in the biomedical sciences.
A second primary
focus of our deliberations was the question of where the line
should be drawn between research that should and research that
should not be subject to IRB review, even under the "exempt
from full review" criterion [usually, if somewhat misleadingly,
referred to as "exempt research"]. As we shall discuss
below, we believe that it is important both for efficiency
and for the credibility of the review system that we define an
appropriate threshold below which research need not be submitted
even under the exempt category. At the same time, we need
to re-affirm the legally mandated requirement that all research
involving human subjects that rises above this threshold be submitted
for IRB review, if only under the exempt category. Here, too,
we would emphasize that such recommendations become more compelling
and persuasive when coupled with the implementation of appropriate
tutorial and certification systems to insure that they are properly
understood and followed.
While human subject
protection issues may not be as prominent in the sociobehavioral
sciences as they are in the medical sciences, there is increasing
pressure from inside and outside the University for sociobe-havioral
scientists to address these issues explicitly in their research.
This involves a need for a change of culture in the way investigators
in a variety of sociobehavioral fields typically engage in research
with human beings. Most notably, sociobehavioral scientists may
have to submit their research for IRB approval, which involves
a layer of review previously not imposed on many of them. To help
investigators embrace the increased emphasis on human subject
issues, the University should make available the tools to educate
its faculty, students and other personnel involved in research
activities. In addition, the University has a responsibility to
monitor and document that its investigators are properly educated
in the ethical conduct of human subjects research. The following
recommendations pertain to these new responsibilities faced by
for human subject protection:
We recommend that the University develop educational tools for
helping personnel become familiar with the issues of human subject
protection, in particular as they pertain to the sociobehavioral
education requirement [certification]:
We recommend that the University institute a requirement that
all personnel (faculty, research fellows, students, and staff)
engaging in research have documented education regarding human
subject protection. At the minimum, such education should
involve an explanation and illustration of when it is appropriate
for investigators to decide that their research does not
require IRB review, even at the exempt level. We also recommend
that newly recruited faculty be required to have documented education
in the University's human subject protection regulations
as part of their appointment process.
and documentation: We recommend
that the University set up a system to monitor and document its
personnel's education with regard to the protection of human
subjects and the ethical conduct of research involving humans.
Suggestions for Implementation
at the University
a web-based tutorial for educating sociobehavioral researchers
about the ethical conduct of research involving human subjects.
This tutorial should have a generic component as well as parts
specific to different fields within the sociobehavioral sciences
[e.g. survey research, ethnographic research, experimental research,
etc.]. This tutorial should have a specific component dealing
with debriefing of experimental subjects.
an electronic IRB protocol submission system that guides sociobehavioral
researchers through all issues potentially pertaining to their
research while they are preparing the protocol submission. This
could be accomplished by (a) tailoring the submission system for
specific branches of sociobehavioral research, (b) linking the
submission procedure to the web-based tutorial referred to under
suggestion A, and (c) providing a web page on the ORA website
with regularly updated links to professional societies' web
pages about (field-specific) human subject protection and ethical
conduct of research issues.
C. Spin off
a new working group that will collaborate with the PennERA development
group to implement suggestion B.
a brochure highlighting the present working group's recommendations
that the University decides to implement. This brochure should
be distributed broadly across the University and include the Schools
of Medicine and Nursing, since some of the recommendations may
affect these Schools as well.
personnel with certification of completed components of education
in human subject protection, ethical conduct of research, and/or
faculty and other personnel to become members of the IRB. This
would have several benefits: personnel become more intimately
familiar with the issues of human subjects research, and the University
may improve its ability to promptly review submitted research
protocols. Such service to the University should be rewarded appropriately.
The Provost and the deans of research intensive schools should
articulate their strong support for IRB service by faculty members.
Service on the IRB should be counted favorably and explicitly
towards evaluation for tenure and/or promotion. In certain circumstances
IRB service might be grounds for a course-release.
additional training for IRB staff regarding human subject protection
in the sociobehavioral sciences. This training should also focus
on efficient and efficacious review procedures that will benefit
both the IRB and the investigators in terms of turn-around time,
required effort and validity of protocol reviews.
typically raises few concerns with respect to human subjects.
In its simplest form, sampled subjects are approached for their
responses to batteries of items. Forms of approach--interviewing--may
be face-to-face or over the telephone; or questionnaires may be
self-administered, as through the mail or via the Internet. Recording
of responses may be by means of "pen-and-pencil," by
tape recording, or with the assistance of a computer. After the
data collection process, the researcher will analyze these data
by statistical methods, ranging from tabulation to the application
of generalized linear models.
In common practice
settings, the costs of participation to respondents are generally
low in an absolute sense: a small amount of subjects' time
only. Benefits to participation variously include financial remuneration,
access to study results, and/or the opportunity to express opinions.
In Institutional Review Board (IRB) terms, risks are generally
minimal, and benefits generally outweigh the risks. Risks to participation
are those attendant to the release of information garnered by
the survey that may embarrass or otherwise harm the human subjects,
especially if individuals can be identified from the reported
study results. These risks can often be mitigated by following
standard research practices and professional ethics published
by the professional society of the discipline at hand. Evolving
practices and technologies within survey research can complicate
the assessment and mitigation of costs and risks to participants.
These include panel studies, in which respondents are contacted
on repeated occasions; and record linkages, e.g., of survey data
to administrative records.
review in exemption category:
We recommend that, by default, survey research be considered exempt
from IRB review if protection of the confidentially of research
subjects is adequately demonstrated (which does not necessarily
involve submitting the survey instrument to the IRB). In addition,
all other applicable criteria for exemption of IRB review must
be fulfilled (e.g., the research must not involve vulnerable populations).
This recommendation is consistent with the already existing regulation
CFR 46.101.b (1--4), but we wish to make it explicit that
submitting the survey instrument should not be necessary.
of written consent: We
recommend that human subjects responding to a survey be considered
to have given informed consent if the research is exempt from
IRB review. In addition, in order to qualify for a default waiver
of written consent, a research protocol must have been presented
to the IRB showing that (a) the human subjects will be informed
of all applicable elements of consent prior to responding to the
survey; and (b) all the criteria for exemption of IRB review are
fulfilled. Here, too, this recommendation is already covered by
existing regulation CFR 46.116, but what is new is the default'
aspect of the waiver of written consent. Investigators presenting
a protocol for review in the exemption category and requesting
a default waiver of consent without providing the survey instrument,
must have documented training in the issues concerning human subjects
protection in survey research.
for exemption from IRB review can be found on the application
for exempt status form available on the website of the Office
of Regulatory Affairs of the University of Pennsylvania. The criteria
for a waiver of written consent can be found in the Standard Operating
Procedures of the IRB of the University of Pennsylvania.
Secondary Data Analysis
The end of the
archetypal research study is often not the end of the analysis
of the data collected by the study. They may live on in the form
of secondary data analysis. It is important to distinguish
the secondary analysis of data from the practice of primary research.
The practice of secondary data analysis typically raises no human
subjects protection concerns and is properly considered to be
below the standard for IRB review. In the following, the
secondary analysis of data is understood to have the following
characteristics: (1) no manipulation of human subjects; (2) no
new data collection; and (3) no identification of research subjects.
This last point follows from the practice of the initial investigator
(whether another investigator or the same person as conducting
the secondary analysis), who in releasing the data is presumed
to have stripped identifiers so that the confidentiality of the
subjects is assured.
In some secondary
data files, it is not possible to assure confidentiality, and
these data files are typically distributed with the explicit understanding
that other researchers must abide by certain rules to maintain
confidentiality. Such circumstances should continue to trigger
IRB review. In these instances investigators should demonstrate
to the IRB that their secondary data are free of subject identifiers
or other features that raise the possibility of identification
of human subjects, in order to obtain exempt status. If this cannot
be demonstrated, then investigators should seek IRB approval for
the secondary analysis of the data, through expedited or full-board
IRB review required: We
recommend adoption of National Human Research Protections Advisory
Committee [NHRPAC, 2001] recommendation 1. Specifically, we recommend
that research on a public use data file, that is, "non-identifiable
data in a publicly available file" not be considered human
subjects research, and therefore not be "under the purview
of IRBs" [NHRPAC, 2001]. In addition, we recommend the inclusion
of non-confidential public records in the definition of a "public
use data file" regardless of whether the data in these non-confidential
public records are identifiable. Implementation of this recommendation
would require that the investigator is certified as per Recommendation
review in exemption category: We
recommend adoption of NHRPAC, 2001 recommendation 6. Specifically,
we recommend that research on a non-public use data file, that
is, non-identifiable data in a non-publicly available or proprietary
file be exempt from IRB review, unless vulnerable populations
are involved. Investigators planning to study non-public use data
files must demonstrate to the IRB that confidentially of research
subjects is protected, either by direct evidence or by showing
that the data supplier already received IRB approval in which
non-identifiability was considered and confirmed (which does not
necessarily involve submitting the survey instrument or the original
consent forms to the IRB).
2001; Draft Recommendations Regarding Public Use Data Files, July
2001, NHRPAC Social and Behavioral Science Working Group.
Suggestions for Implementation
at the University
an application form for exemption from IRB review specific for
survey research and secondary analysis of non-public use data
guidelines to investigators about when and how to apply for a
Certificate of Confidentiality.
In a broad class
of research in the sociobehavioral sciences, the questions posed
evolve in the course of investigation. This is the case, for instance,
in ethnography, where research questions may only be clarified
after a period of observation and where current findings drive
the next steps in the study in an evolving manner. Typically,
this class of research involves observation of human behavior
in the field, with or without active participation by the investigator.
While such studies may be common in the sociobehavioral sciences,
they do not fit the stereotypical mold of the hypothesis-driven,
fixed-protocol research that is central to existing regulations
designed for the protection of human participants. For evolving
research, such as ethnographic research, oral history, and focus
groups, among others, guidelines for when to seek IRB review,
and how to make the IRB review process efficient, can be given
within the framework of existing regulations. The following recommendations
are made for clarification of the roles of investigators and the
IRB in the process of human subjects protection as it relates
to evolving research.
IRB review required: We
recommend that research involving only non-interventionist
observations of publicly occurring behavior, for which
no identifying information is included in the study records, be
considered not to require review by the IRB. By default,
this form of research does not pose risk to human subjects, making
it unnecessary to have the IRB approve it, even under the exempt
category. We also recommend that the definition of publicly
occurring behavior be understood to include publicly accessible
parts of the Internet.
research certification: Consistent
with Recommendation 2, we recommend that a program be established
whereby investigators can become certified to conduct ethically
sound evolving research. Investigators should be allowed to use
their certification as a reference for describing evolving research
studies to the IRB. This should serve to eliminate the need to
have investigators spell out the details of a dynamic study protocol.
The IRB can be assured that the research will be conducted in
ethically appropriate fashion, with full protection of the human
subjects, when investigators state that research will be conducted
within the confines of the ethical framework laid out in the certification
program. It should be noted that different investigations by the
same investigator(s) must be submitted to the IRB as separate
research protocols, and cannot be seen as part of a single study
evolving from one investigation into another.
As part of their
professional activities, investigators typically engage in exploratory
research on a regular basis. Such research involves conceiving
or refining a research question through harmless observation,
casual conservation, browsing existing data, etc. IRB regulations
stipulate that "research is a systematic investigation, including
research development, testing and evaluation, designed to develop
or contribute to generalizable knowledge" [Federal Policy
CFR 46.102(d)]. This raises the question whether and, if so, when
exploratory research falls under the purview of the IRB. The following
recommendation is made to clarify the role of the IRB in the review
of exploratory research.
IRB review required upon disclosure only:
We recommend that exploratory research be considered not
to require review by the IRB, even under the exempt category,
if the following conditions are met:
a. The exploratory
research does not involve any vulnerable populations (e.g.,
b. The exploratory
research involves no interventions by the investigators;
c. The exploratory
research participants are not identifiable from the study
d. The exploratory
research data and results are not disclosed or published.
research must be submitted to the IRB for retroactive review if/when
the investigator anticipates or decides to disclose the data and/or
results, or to submit them for publication--unless IRB review
is still not required on other grounds (e.g., Recommendation 8,
above). Such retroactive review should have the same procedures
as if the study protocol had been submitted as a new study before
the onset of the exploratory research. If the IRB does not give
approval, and appeal of the IRB's decision does not change
this, then the data and results cannot be disclosed in any form.
If the investigator decides to begin a systematic investigation
on the basis of exploratory research for which no IRB review was
required, then a study protocol must be submitted for IRB review
as per existing rules and regulations (unless IRB review is not
required on other grounds). Investigators are advised not to wait
until the last possible moment to seek IRB approval for their
Suggestions for Implementation
at the University
a web-based tutorial for educating field researchers about the
ethical conduct of research involving human subjects.
a web-based course to implement the certification program referred
to in Recommendation 2 above.
course directors of courses on research methods or similar topics
to help prepare students for taking the web-based course referred
to in suggestion K above.
the Office of Regulatory Affairs staff about what information
to expect from the investigators of field research studies and
how to apply the exempt and expedited categories of review to
the IRB to give retroactive approval of exploratory research that
has reached the threshold of systematic investigation where IRB
review becomes necessary.
of Human Subjects
used technique in experimental sociobehavioral research and other
fields of inquiry is the temporary manipulation of individuals'
behavioral or perceptional states to measure or demonstrate a
specific behavior, attitude or way of thinking. Often these manipulations
involve deceiving experimental subjects about the purpose of the
experiment, or about some trait or state of the subjects themselves
(e.g., giving them false feedback about their performance). In
other cases subjects might be exposed to messages intended to
alter their beliefs or attitudes. In the typical instance, at
the end of the experiment the true purpose of the research is
revealed (e.g., subjects are informed of any deception about the
purpose of the experiment, about their abilities or traits, or
about the impact of the messages they were exposed to, etc.).
It is generally assumed that subjects' temporary states are
undone by means of such debriefing. While many research studies
involve some kind of debriefing, little attention is commonly
paid to whether or not the debriefing procedures accomplish the
intended purpose (i.e., to undo the experimentally induced state).
Yet, this issue may have important implications for human subject
is an issue, then presumably some part of the consent procedure
was omitted (e.g., subjects were not told every aspect of the
study, or they were purposely deceived about some aspects of the
study). This requires a waiver of aspects of informed consent,
which automatically triggers heightened awareness among IRB reviewers.
Nevertheless, the discussion then often deals with whether or
not that waiver is appropriate; it does not generally focus on
the effectiveness of the debriefing procedure. Thus, heightened
awareness of the debriefing issue may help to improve the ethical
conduct of research on human beings. In some cases, particularly
when a manipulation may lead to negative effects, it might be
appropriate to require researchers to conduct follow-up investigations
to assure that debriefing efforts have been successful.
of debriefing: We recommend
that specific attention be paid to the debriefing of subjects
during the IRB review of experimental protocols. We also recommend
that investigators be asked to address this issue specifically
in their submitted study protocols and, particularly in the case
of manipulations that may cause negative effects, to describe
if and how the effectiveness of the debriefing methods they propose
to use will be assessed.
Group on Human Subjects Research
the Sociobehavioral Sciences
Martha Farah, Psychology
Larry Gross, Communications,
Mark Pauly, Health
Herb Smith, Sociology
Greg Urban, Anthropology
Hans Van Dongen,