Human Subject Protection
Committee on the
Use of Human Subjects in Research
Harvard University *
A program designed for faculty, staff, and students
involved in research using human subjects.
*Modified by the Kennedy School of Government
December2001
Welcome to the Human
Subject Protection Training Program
This program should take less than one hour to
complete. At the end of the program you will be
asked to send an email message confirming your
completion of the tutorial to your PAC/SYP
Seminar Leader and to Julie Wilson, Chair of the
KSG human subjects advisory committee.
This on-line exercise presents a survey of important
issues relating to the conduct of research involving
human subjects.
The following topics will be addressed:
• Definitions of research involving human
subjects
• History
• Ethical principles
• University and federal rules regarding the
use of human subjects
• Roles and responsibilities
• Informed consent
• Special categories of research and
research subjects
At the end of the course is a
bibliography and a list of useful
web sites where further
information is available.
Definitions
Definitions
Research is a systematic investigation
designed to develop or to contribute to
generalizable knowledge. A research
investigator may be faculty, student, or
staff. The intent of the project need not
be to generate results for publication.
Definitions
Research may involve direct interactions,
such as obtaining data by taking medical
histories, or other interview procedures, or
administering psychological tests, or
drawing blood
samples or collecting
saliva samples, or
conducting other
diagnostic
procedures.
Definitions
Research may also involve indirect
interactions, such as the analysis of
specimens or data
already obtained
from people (either
by you or by others).
Definitions
A human subject is a living individual
from or about whom an investigator
conducting research obtains data
through intervention or interaction,or
identifiable private information.
Definitions
Intervention includes both physical
procedures for data gathering
(venipuncture, EEG recordings, etc.)
and manipulations of
the subject or the
subject’s environment
that are performed for
research purposes.
Definitions
Interaction includes communication or
interpersonal contact between
investigator and subject.
Definitions
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.
Definitions
Private information also includes
information that has been provided for
specific purposes by an individual, and
which the individual can
reasonably expect
will not be made
public (for example,
a school or medical
record or a loan
application).
Smith, John
Definitions
Note that private information must be
individually identifiable — that is, 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.
Definitions
Would the following activities
be considered research
involving human subjects ?
A telephone survey of middle school
teachers in the Greater Boston area to
learn about television watching habits
Definitions
Would the following activities
be considered research
involving human subjects ?
A telephone survey of middle school
teachers in the Greater Boston area to
learn about television watching habits
Yes, because it is a systematic
investigation with interaction
between the investigator and
the subjects
Definitions
Research involving human subjects?
Review of patients’ emergency room
records to determine the relationship
between age and type of traumatic injury
Definitions
Research involving human subjects?
Review of patients’ emergency room
records to determine the relationship
between age and type of traumatic injury
Yes, because it is a systematic
investigation in which the investigator
is obtaining identifiable private
information (from the subjects’
medical records)
Definitions
Research involving human subjects?
Videotaping a Memorial Day Parade to
determine later which groups provoked the
most enthusiastic spectator response.
Definitions
Research involving human subjects?
Videotaping a Memorial Day Parade to
determine later which groups provoked the
most enthusiastic spectator response.
Probably not. Some subjects’ images
may be identifiable, but there is no
interaction between the investigator
and the subject, and the activity
occurs in a public place.
Definitions
Research involving human subjects?
Collection of blood samples from needle
exchange program participants to determine
HIV status
Definitions
Research involving human subjects?
Collection of blood samples from needle
exchange program participants to determine
HIV status
Yes, because there is interaction with
subjects and an intervention (drawing
blood)
Definitions
Research involving human subjects?
Interviewing Bruce Springsteen about the
songs he played on his recent concert tour
Definitions
Research involving human subjects?
Interviewing Bruce Springsteen about the
songs he played on his recent concert tour
Probably not. There is interaction, and
the subject may be clearly identifiable,
but the activity is not designed to yield
generalizable knowledge.
Definitions
An Institutional Review Board (IRB)
is a federally-mandated committee
established to review and approve
research involving the use of human
subjects.
There are three IRBs at Harvard, each a
standing committee of the faculty.
Definitions
• Human Subjects Committee (serving the
School of Public Health)
• HMS/HSDM Committee on Human Studies
(serving the Medical School and the School
of Dental Medicine)
• Committee on the Use of Human Subjects
in Research (serving the Faculty of Arts and
Sciences, Graduate School of Education,
Kennedy School of Government, and all other
non-medical professional schools and
institutes)
Background
Background
At least three parties have legitimate interests in
any research venture involving human subjects: the
investigator who initiates it, the society that provides
the conditions for it, and the subjects who
participate in it.
Background
Ultimately, if the study is important, their interests
do not conflict, but in the short range they can and
often do. Sad experience has demonstrated that
able and conscientious scholars sometimes fail to
give proper weight to
considerations that are
salient to the interests of
either the public or the
subjects. To leave all the
decisions solely in the
hands of one of the
parties involved is not
wise.
Background
For this reason, the Faculty of Arts and Sciences
established its review system almost forty years
ago. Review is administered by a standing committee
of the Faculty, the Committee on the Use of Human
Subjects in Research. The policies and procedures
under which the Committee operates were voted by
the President and Fellows of Harvard College (most
recently in 1981) and can be found at:
www.fas.harvard.edu/~research/greybook/humsubs.html
Background
For similar reasons, most federal agencies that
sponsor research involving human subjects have
mandated similar review systems for grantees.
Harvard’s IRB system meets both the University’s
requirements and the federal requirements for prior
review of research involving human subjects.
Background
No one has illusions that the committee system —
or any other set of institutionalized procedures —
is a substitute for ethically-alert scientists who are
sensitive to the well-being of their subjects.
That is the sine qua non of meaningful protection
and no system relieves the investigator of the
primary responsibility for securing subject's rights
and welfare. The committees serve only to remind
all concerned of the network of interdependence
that exists and to interpose a disinterested
judgment where necessary.
History
History
The formal codification of ethical guidelines for the conduct of
research involving humans began in the late 1940s.
In 1946, twenty-three Nazi
defendants, twenty of them
physicians, were tried for war
crimes and crimes against
humanity. Sixteen of the
defendants were found guilty.
Seven were hanged and nine were
sentenced to prison terms ranging
from ten years to life.
The world was shocked at the revelations of experiments
these doctors conducted, including studying the effects of
extreme cold, high altitude, exposure to noxious substances,
poisons, infection with all manner of disease, and list of other
dreadful procedures.
History
Out of this experience grew a set of principles known as
the Nuremberg Code, which have remained remarkably
durable. Although they were intended to apply primarily to
medical research, they serve as useful guidelines for the
conduct of other types of research, including research
typically conducted by behavioral and social science
investigators at Harvard.
Jane Calhoun:
Jane Calhoun:
Jane Calhou
Jane Calhoun:
Jane
Jane Calhoun:
History
Principles Taken from the Nuremberg
Code
• Researchers are responsible for obtaining voluntary informed
consent from their subjects. They should not delegate this
responsibility to others.
• Experiments should be designed to benefit society, and not be
random or unnecessary.
• Precede human research with animal experiments and studies
on the natural history of disease whenever this is possible, so
that the anticipated results will justify the performance of the
experiment.
Jane Calhoun:
Jane Calhoun:
Jane Calhou
Jane Calhoun:
Jane
Jane Calhoun:
History
Nuremberg Code (continued)
• Research should involve no unnecessary physical or mental
suffering or exposure to harm. In particular, the experiment
should not be conducted if there is reason to believe it may lead
to death or disabling injury of a subject, "except, perhaps, in
those experiments where the experimental physicians also
serve as subjects.”
• Risks should be reasonable based on the possible benefits of
the research, which should take into account the humanitarian
importance of the problem being studied.
History
Nuremberg Code (continued)
• Researchers must be scientifically qualified and should perform
professionally at every stage of the experiment.
• Subjects must be at liberty to withdraw at any time of their own
free will.
• The experimenter should stop the study at any time if in his
opinion subjects may be harmed by continuing to participate.
History
Increasing
Public Awareness
History
Over the next twenty-five years, several studies widely reported in
the press helped to focus the public's interest on research involving
human subjects in this country and led many people — including
many in Washington — to think that some kind of federal oversight
of research might be necessary.
• The Wichita Jury Case
• Immunological research at The Jewish Chronic Disease
Hospital
• LSD and Psilocybin research by Timothy Leary and Richard
Alpert
• Research on obedience to authority by Stanley Milgram
• PHS-funded research on the natural course of untreated
syphilis in Tuskegee
History
The Wichita Jury Case
In 1953, University of Chicago researchers tape
recorded the deliberations of juries in six civil cases,
with the consent of the judge and counsel for both
sides, but without the jurors’ knowledge. The
researchers were
investigating whether
the comments of some
lawyers might have
inappropriately
affected the
deliberative process.
History
Wichita Jury Case (continued)
When word of the research leaked out (one of the tapes was
played at a Bar Association conference), public outrage led to
Senate hearings chaired by James O. Eastland.
Even though there was no evidence that the recordings had
influenced the actions of the jury, it was felt that the possibility of
further recordings being made might affect jurors’ statements or
deliberations.
A federal law was passed in 1956 banning all recording of jury
proceedings.
History
The Jewish Chronic Disease Hospital
In 1963, researchers from The Sloan-Kettering Institute
began a study at Brooklyn’s Jewish Chronic Disease
Hospital to investigate certain aspects of the body’s reaction
to foreign tissue. The protocol involved injecting a culture of
cancerous cells under the skin of elderly, disabled patients
with compromised
immune systems. Many
patients were incapable
of giving informed
consent and even those
who were capable were
told the doctors were
conducting a “harmless
skin test.”
History
Jewish Chronic Disease Hospital (continued)
Similar studies had been performed in healthy individuals and in
cancer patients, and the researchers had no reason to believe
that their actions would lead to the development of cancerous
tumors in their subjects
Nevertheless, when members of the hospital’s board of
directors learned of the study, they took the hospital to court to
force disclosure of the study records. Subsequent headlines
blared that “Live Cancer Cells” had been injected into helpless
elderly patients, and led to the termination of the study. Two of
the physicians responsible for the research were put on
probation for a year. Three years later, despite these sanctions,
one of the researchers was elected president of the American
Association for Cancer Research.
History
Timothy Leary and Richard Alpert
These two Harvard faculty (Leary was Lecturer in Social
Relations and Alpert was Assistant Professor at the Ed School)
worked together in the early 1960s at the Center for Research
in Personality. Hallucinogenic drugs were not then illegal and
they had experimented with psilocybin and LSD obtained from
Sandoz Pharmaceuticals, which they also dispensed to friends,
associates, and students.
As time passed, the research became more and more freewheeling and, in the opinion of many departmental colleagues,
rapidly lost any semblance of academic rigor.
History
Timothy Leary and Richard Alpert (continued)
At this time the University Health Services was just formulating
its policies regarding the use of human subjects. An agreement
was reached with Alpert and Leary in the fall of 1961 that they
would not include any undergraduates in their research.
In early 1962, the two separated their activities from the Center
for Research in Personality and formed their own private
organization, the International Federation for Internal Freedom
(IFIF). Eventually, both were fired from the University; Alpert for
having given psilocybin to an undergraduate in 1962, in
violation of the UHS agreement, and Leary for failing to teach
his scheduled classes in the spring of 1963.
History
Research on Obedience to Authority
At Yale University in the early 1960s, Stanley Milgram devised a
series of experiments to examine the circumstances under
which naïve individuals would follow instructions whose
consequence was the apparent injury of another person.
His protocol involved a “teacher” (the subject) and a “learner”
(actually a confederate of the experimenter). The teacher was
to click one of a series of switches on a large and impressive
device each time the learner gave a wrong answer in a wordpairing test. The teacher was told that each switch would
administer a painful electric shock to the learner, of increasing
intensity. Realistic cries of pain came from a separate room in
which the learner was strapped to his chair--later, pounding on
the wall, and, ultimately, at switches labeled up to “450 volts,”
no response.
History
Research on Obedience to Authority (continued)
Teachers who objected to the process were told simply that they
must go on-- “The experiment requires that you continue.”
The research was designed to explore at what point people
would defy authority in the face of a clear moral imperative. To
the surprise of many (including Milgram), 26 of 40 subjects went
through the process to the end, clicking the switch to administer
the maximum shock. (In reality, of course, the learner received
no shocks and his responses were all on audiotape.)
Publication of the research, and a dramatic film of the study,
generated much controversy among psychologists. Some
argued that subjects had been harmed--if not through the stress
of the experiment itself, then through the “inflicted insight” into
their own personalities.
History
Research on Obedience to Authority (continued)
Followup interviews of the subjects indicated that only 1%
reported feeling “sorry or very sorry” to have participated.
However, that finding itself was questioned; some writers
suggested that the subjects were only saying what Milgram
wanted to hear, or were trying to justify their own participation
and their failure to defy the experimenter’s authority.
Nevertheless, the relevance of the research to current events—
including the trial of Adolph Eichmann, who maintained that he
was just following orders as he signed papers condemning
concentration camp victims to death—made the findings all the
more compelling.
History
Public Health Service study on the natural
progression of untreated syphilis
(“Tuskegee Syphilis Study”)
This research began in 1932. 600 men, all poor and all black,
were enrolled in a study ostensibly designed to monitor and
record their health. Some were told they had “bad blood” but
none, apparently, were told they had syphilis. They were given
free medical attention, a hot meal each time they came to the
clinic, and a promise that the
government would cover their burial
expenses. Two-thirds of the
subjects had evidence of tertiary
syphilis when they were recruited;
many of the control subjects
acquired the disease during the
course of the study.
History
Tuskegee Study (continued)
However, even after penicillin was discovered to be effective in
treating syphilis, in 1943, it was not offered to the subjects as
treatment.
The project ended in 1972 after details were reported in the
press. Senator Edward Kennedy held hearings on the study,
and a class action suit was later brought against the
government (including the Department of Health, Education,
and Welfare (DHEW) — now known as the Department of
Health and Human Services — the Public Health Service, the
Centers for Disease Control, and several other government
agencies). The case was settled for $10 million in 1974, to be
shared among the surviving subjects and the heirs of those no
longer living.
In April, 1997, President Clinton formally apologized on behalf
of the federal government to the survivors.
History
The Kennedy hearings were a
galvanizing force within the
government. Subsequent
passage of the National
Research Act of 1974 authorized
the DHEW to issue completely
redesigned regulations on the
use of human subjects in
federally-funded research.
Ethical Principles
Ethical Principles
Ethical Principles
On July 12, 1974, when the National Research Act
was signed into law, the National Commission for
the Protection of Human Subjects of Biomedical
and Behavioral Research was created. A primary
charge to the National Commission was to identify
ethical principles to guide research involving human
subjects. The Commission’s
Belmont Report (formally
titled Ethical Principles and
Guidelines for the Protection
of Human Subjects of
Research) was published in
1978.
Ethical Principles
Ethical Principles
The Belmont Report enumerates three
basic principles for investigators conducting
research with human subjects:
• Respect for persons
• Beneficence
• Justice
Ethical Principles
Belmont Report
Ethical Principles
1. Respect for Persons
Individuals should be treated as autonomous
agents, with the right to self-determination.
Autonomy refers to the individual’s right to
choose whether to participate or not. Autonomy
is protected by the consent process. Each
prospective subject must be given ample
information and time to decide whether to
participate in a research study
Ethical Principles
Belmont Report
Ethical Principles (continued)
In addition, persons with limited or diminished
autonomy are entitled to special protections
Not all human beings are capable of selfdetermination; special precautions must be
taken to protect members of potentially
vulnerable populations. There are specific
federal rules that must be followed when
research activities involve fetuses, pregnant
women, human in vitro fertilization, children,
prisoners, or subjects who may have
diminished capacity.
Ethical Principles
Belmont Report
Ethical Principles (continued)
2. Beneficence
• Do no harm
• Maximize possible benefits and minimize
possible harms for science, humanity, and the
individual research subjects
Ethical Principles
This principle is the basis of risk/benefit
assessment, in which investigators, institutions,
and IRBs all seek to ensure that any risks are
minimized, and not taken unless there is likely
to be a benefit to the
individual subject.
Types of risk include
emotional, financial,
psychological, social,
and legal, as well as
physical.
Ethical Principles
Belmont Report
Ethical Principles (continued)
3. Justice
Justice requires that the burdens and the benefits
of research be distributed equitably. This means
that research procedures should be carefully
chosen and administered, and that costs and
benefits should be equitably distributed among
persons and groups. Subject selection should not
be based solely on convenience to the investigator.
Ordinarily, those who bear the risks of research
should be those who benefit from it.
Ethical Principles
Harvard University’s rules
regarding the use of human
subjects in research
Ethical Principles
By vote of the President and Fellows on 7
December 1981, the Committee on the Use
of Human Subjects in Research is
“authorized to review and to approve or
disapprove, or state conditions for, the
conduct of any research involving a human
subject or subjects, in accordance with the
policies stated herein.” The wide discretion
given the Committee (“any research. . . ”) is
intended to make clear its authority to
intervene as necessary to protect research
subjects.
Ethical Principles
Federal rules regarding the
use of human subjects in
research
Ethical Principles
Federal regulations for the protection of
human subjects are codified at Chapter 45 of
the Code of Federal Regulations, Part 46
(45 CFR 46). This document is referred to as
"The Common Rule" because it has been
adopted by most federal agencies that fund
human subjects research.
All Harvard investigators conducting research
that is supported (even in part) by federal
funds must adhere to the provisions of 45
CFR 46, in addition to the requirements of the
Vote of the President and Fellows.
Ethical Principles
Any institution with an IRB that reviews and
approves federally-funded research must file
an agreement with the Department of Health
and Human Services stating the methods by
which the institution will protect the welfare of
all research participants (regardless of the
source of funding, if any, for the research).
This agreement serves as the IRB’s “license”
to approve human subjects research, and is
called a Multiple Project Assurance (MPA).
Ethical Principles
Harvard has negotiated three Multiple Project
Assurances: one for the Faculty of Arts and
Sciences (and the Cambridge campus in
general), one for the Medical School, and one
for the School of Public Health.
The MPA for the Faculty of Arts and Sciences
can be found at
www.fas.harvard.edu/~research/MPA.html
Roles and Responsibilities
Roles & Responsibilities
Roles and Responsibilities
Three parties involved in the research
process have their own separate, but
interrelated, responsibilities:
• the Investigator (and other research staff)
• the Institutional Review Board
• the University
Roles & Responsibilities
Investigator
The Investigator bears primary
responsibility for the protection of
human subjects in the study
Roles & Responsibilities
Investigator responsibilities
– In consultation with the IRB, determines
whether research involving human subjects
requires IRB approval
– Submits protocol to the IRB for approval
before the research begins
– Obtains (and documents as required)
informed consent from all subjects
Roles & Responsibilities
Investigator responsibilities
(continued)
– Ensures the confidentiality of subject data
– Immediately suspends research if any
subject is injured, or if previouslyunanticipated risks are identified; obtains
IRB approval before proceeding
– Applies to the IRB for approval of changes
to previously-approved protocols
Roles & Responsibilities
Institutional Review Board
The IRB must understand and apply the
University’s rules and federal, state, and
local regulations on the use of human
subjects
in research
Roles & Responsibilities
IRB Responsibilities
• Reviews, and has the authority to approve,
require modification of, or disapprove, all
human subjects research activities,
including proposed changes to previouslyapproved research.
• Works with investigators to develop
ethically-sound protocols
• Provides training and education as needed
and requested on the use of human
subjects in research.
Roles & Responsibilities
IRB Responsibilities (continued)
• Facilitates constructive communication
among the research administrators,
department heads, research investigators,
clinical care staff, human subjects, and
institutional officials as a means of
maintaining a high level of awareness
regarding the safeguarding of the rights
and welfare of research subjects
Roles & Responsibilities
IRB Responsibilities (continued)
• Forwards to the appropriate University
officials any significant or material findings
or actions regarding injuries or other
unanticipated problems or risks to subjects;
any serious or continuing noncompliance
with University or federal regulations; and
any suspension or termination of IRB
approval
Roles & Responsibilities
University
Although primary responsibility for protection
of human subjects from risk of harm is borne
by the principal investigator and is shared by
all others involved in the conduct of the
research, this does not
relieve the institution of
its own responsibility for
the performance of
research involving human
subjects conducted by
University investigators.
Roles & Responsibilities
University Responsibilities
• Ensures that IRB and University policies
are in compliance with evolving law and
regulations
• Publicizes human subjects policies and
requirements to the research community
• Establishes and maintains appropriatelyqualified IRBs
• Provides support for the IRBs and their
staff
Special Issues
Special Issues
• Informed Consent
• Privacy, Confidentiality, and
Anonymity
Informed Consent
Special Issues
In the simplest terms, informed consent
means that the investigator has shared
enough information about the study with
a prospective subject so that the subject
knows what the experience and effects
of being in the
study will be like
and, with that
knowledge, agrees
to participate.
Special Issues
It is important not to confuse the
informed consent process with the
consent form.
The consent form is simply a written
confirmation of the agreement between
investigator and the subject concerning
the content and terms of
the proposed activity. In
some studies that present
no risk, a written consent
form may not be required.
Special Issues
Think for a moment about the things you
would want to know before you volunteer
to participate in a research study:
• That it is a research project
• What the purpose of the project is
• What the experience of participation is going
to be like
• How long participation will take
• What compensation you will receive
Special Issues
Things you would want to know (continued)
• What (if any) are the risks of injury or other
distress, and what will happen if you are injured
• What else might happen to you
– Embarrassment?
– Unpleasant side effects?
– Disruption of normal schedule or activities?
• How participation might benefit you
• How your participation might benefit others
if the research is successful
Special Issues
You would also want to understand:
• That you don’t have to participate if you don’t
want to--for whatever reason
• That refusal to be in the study will carry no
penalty
• That if you start to participate and then
change your mind, you can stop
• Whether there are any alternate procedures
that might instead be used (if the study
involves medical interventions or treatment)
Special Issues
You would also want to understand (continued):
• What will happen to your personal information
or materials or tissue samples gathered in the
study
• How your identity and privacy will be
protected
Special Issues
Finally, you need to understand that you
do not waive any legal rights by
agreeing to participate in the study,
regardless of
what a consent
form may or may
not say.
Special Issues
There are special rules and
requirements for informed
consent when the research
is federally funded.
In some cases, consent must be
written; in others, an oral exchange is
sufficient. In some cases, certain
elements of informed consent may be
waived.
Special Issues
Waiver of Consent
The IRB may waive or alter the elements of
Informed Consent if the following conditions
are met:
– The research involves no more than minimal risk
– The waiver will not adversely affect the rights and
welfare of the subject
– The research could not practicably be carried out
without the waiver or alteration
– If possible, subjects will be provided with
additional pertinent information after participation
Special Issues
Information about the required elements
for informed consent when federal funds
are involved can be found in the federal
human subjects regulations at
45CFR46, section 116.
If you have questions about whether
written consent is needed in your study,
or what the consent process should
include, check with your IRB office.
Privacy,
Confidentiality,
and Anonymity
Special Issues
Privacy
Privacy refers to a state of being free
of unsanctioned intrusion.
Ordinarily, individuals have a
right to privacy; that is,
control over the extent,
timing, and circumstances of
sharing themselves, or
information about
themselves, with others.
Special Issues
Confidentiality and Anonymity
Confidentiality and anonymity
are relevant to the treatment of
individuals’ private information,
both within and outside the
research context.
Special Issues
Confidentiality refers to an agreement
with an individual regarding the
treatment of information obtained from
or about that individual.
Data are confidential if
they will not be disclosed
outside the context of the
research project in a way
that reveals or implies a
subject’s identity.
Smith, John
Special Issues
Anonymity refers to the complete
absence of names or other identifying
information.
Data are anonymous if
it is impossible for the
investigator--or
anyone else--to
connect a subject with
the data they've
provided.
X
Special Issues
In the following situations, the data should
be kept confidential, but will usually not be
anonymous
• The use of audiotapes to record interviews
(voices may be recognized)
• Use of Social Security numbers to identify
subjects (can easily be linked to identity)
• Use of ID numbers on subjects' data with a
separate name/number list
Special Issues
Confidential, but not anonymous:
• Studies of defined groups of subjects with
distinctive characteristics, experiences, or
information
– Use of narrow descriptive categories (“Asian
male executive nurse in a healthcare
organization”)
– Recording or reporting of unusual personal
information (a small group of employees
describing their experience with a new
management system)
Special Issues
Violations of subject privacy and
confidentiality are potential risks in much
human subjects research. Such violations
may result in serious harm to subjects:
damage to their reputation, loss of
employment, or even criminal prosecution.
Investigators are required to
minimize these risks by
respecting the privacy of
subjects at all times, and maintaining all
research records in a secure manner.
Special Issues
It is nevertheless possible, and may be
entirely proper, to conduct a study in which
data will not be kept confidential (e.g., an oral
history project where subjects give
permission for their names to be published
with their comments).
Regardless of the degree to which
confidentiality will be maintained,
investigators must explain to subjects any
limits of confidentiality that reasonably can be
anticipated.
Special Issues
Research data are ordinarily not privileged
and may be subject to subpoena in the
absence of special protection. When the
issue under study requires subjects to reveal
highly sensitive information, such as criminal
behavior or information about their own drug
dependency, investigators can apply to the
U.S. Department of Health and Human
Services for a Certificate of Confidentiality,
which will protect the data from outside
inquiry. Investigators should consult their IRB
office for further information.
Special Categories
of Research Subjects
Special Categories of Subjects
• Vulnerable Populations
• Research Involving Children
• Research Involving Students
Special Categories of Subjects
Vulnerable Populations
Federal regulations
require that IRBs give
special consideration to
protecting the welfare of
potentially-vulnerable
subjects, including
children, prisoners,
pregnant women, or
cognitively impaired
individuals.
Special Categories of Subjects
Vulnerable Populations (continued)
Regulations at 45 CFR 46 identify specific provisions
for federally-funded research involving
• pregnant women and in vitro fertilization
(Subpart B)
• prisoners (Subpart C)
• children (Subpart D)
Research involving cognitively impaired individuals
should include additional safeguards to ensure that
their rights and welfare are protected, as noted at
45 CFR 46.111(b)
Special Categories of Subjects
Vulnerable Populations (continued)
Although some research involving human subjects is
exempt from the federal regulations, the exemptions
do not apply to subjects identified in Subparts B or C
of 45 CFR 46, nor does the exemption at section
101(b)(2) (survey or interview research) apply to
research involving children.
Investigators planning research with subjects
identified in Subparts B and C, or with cognitively
impaired individuals, should consult with the IRB
office prior to submitting an application.
Special Categories of Subjects
Research Involving Children
Definitions
• Children are persons who have not
attained the legal age for consent to
treatments or procedures involved
in the research. (In Massachusetts,
in most cases, this is age 18.)
Special Categories of Subjects
Research Involving Children
Definitions
• Assent means a child’s affirmative agreement
to participate. Mere failure to object, absent
affirmative agreement, should not be construed
as assent.
• Permission means the agreement of parent or
guardian to the participation of their child or
ward in a research project.
Special Categories of Subjects
Research Involving Children
(continued)
When children are involved as
subjects of research, the
researcher must ordinarily
obtain both the assent
of the child and
the permission
of the parent.
Special Categories of Subjects
Research Involving Children
(continued)
Federal Regulations require IRBs to
document in their discussion the risks
and benefits of the research and to
classify research involving children into
one of four categories.
Special Categories of Subjects
Research Involving Children
(continued)
1) Research not involving greater than minimal
risk (i.e., where the probability and magnitude of
harm or discomfort anticipated in the proposed
research are not greater than those ordinarily
encountered in daily life or during routine
physical or psychological tests.)
2) Research involving greater than minimal risk,
but presenting the prospect of a direct benefit to
the child.
Special Categories of Subjects
Research Involving Children
(continued)
3) Research involving greater than minimal risk
and no prospect of direct benefit to individual
subjects, but likely to yield generalizable
knowledge about the subjects’ disorder or
condition.
4) Research not otherwise approvable that
presents an opportunity to understand, prevent,
or alleviate a serious health problem affecting
the health or welfare of children.
Special Categories of Subjects
Research Involving Children
(continued)
Note that the fourth category must also be
reviewed by the Secretary of DHHS, in
consultation with a convened panel of experts,
before being allowed to proceed.
Use of Students
as Research Subjects
Special Categories of Subjects
College students can be excellent participants
in research. They are readily available and
often in a position to understand research
procedures and questions. Research
participation may also be a valuable learning
experience. However,
they are also in a
dependent position in
relationship to faculty
and teaching staff, and
thus potentially
vulnerable.
Special Categories of Subjects
Instructors and teaching fellows are
discouraged from collecting research data
from students in their own courses or
sections because of the potential for
coercion, and the
problems inherent in
student revelation of
private information.
Smith, John
Special Categories
of Research
Special Categories of
Research
• Survey research
• Deception
Survey Research
Special Categories of Research
Often, survey research is exempt from
the requirements of IRB review.
However, some survey research may
involve vulnerable populations, or deal
with sensitive topics. In some cases
(research on bereavement or other
personal loss, for instance) the survey
process itself may be stressful or
potentially harmful to subjects.
Special Categories of Research
Survey research may require prior IRB
review and approval when
 subjects are minors, patients, or
adults not competent to consent
 research deals with sensitive topics
 identifiers are recorded or linked to
data
Your IRB office can advise you on
whether your survey project will require
IRB review.
Deception
Special Categories of Research
In some research, particularly some
research in social psychology, fully
explaining the purpose of a study to
subjects in advance may bias their
actions or responses. For instance,
telling subjects in advance that a study
is about the effects of stereotypes on
behavior may cause subjects not to act
naturally.
Special Categories of Research
"Deception" includes not only provision
of false or misleading information to
subjects prior to or during the research,
but also the withholding of information
that may be relevant to subjects'
decision about participation or actions in
the research context.
Special Categories of Research
Withholding information from subjects
during the informed consent process
is ordinarily permissible only if the
following four conditions are met:
1) The research presents no more than
minimal risk to subjects
2) The withholding will not adversely
affect subjects’ rights and would be
unlikely to affect their decision about
participation
Special Categories of Research
3) Prior disclosure would harm the
scientific validity of the study
4) Where appropriate, subjects will be
provided with a complete explanation
(“debriefing”) as soon as possible after
the conclusion of the experiment
Note that prior explanation of risks
cannot be withheld.
Special Categories of Research
Nevertheless, investigators should be careful
about using deception as a research tool.
Subjects are, after all, volunteering to
participate in research and they have a right
to be treated with respect.
One useful litmus may be: after a subject has
completed the study, and been fully
debriefed, will he or she understand and
accept the reason for the deception, and not
leave the study embarrassed or disheartened
or upset?
Special Categories of Research
Example
The following example of a study in which subjects
were deceived shows how deception -- where
necessary -- can be properly managed:
Subjects were told that language ability was being
studied, and asked to construct grammatically correct
sentences from groups of words given to them. In
one condition there were many words associated with
old age, such as Florida, old, grey, lonely, forgetful,
etc. The other condition had only words that were
neutral.
Special Categories of Research
Example (continued)
Subjects were thanked for their participation and
dismissed. Unbeknownst to them, their walking
speed was measured as they walked down the
corridor leaving the lab. Those subjects who had
been given words traditionally associated with old
age took significantly longer to walk down the hall
than those given neutral words.
Before the subjects left the building, the investigator
caught up to each one and gave a complete oral
debriefing and a written version.
Resources
Resources
Resources
A list of web sites relevant to human
subjects research, including all the sites
referenced in this tutorial, and a
bibliography of useful books and
articles, is available through your
school’s IRB web site. You may find it
useful to bookmark the location for easy
reference.
Resources
Faculty of Arts and Sciences
(and other non-medical schools):
www.fas.harvard.edu/~research/hsbib.html
Medical School and School of Dental Medicine:
www.hms.harvard.edu/orsp/hsbib.html
School of Public Health
www.hsph.harvard.edu/hsc/hsbib.html
Registration
Registration
Please confirm your completion of the human subjects tutorial,
by sending an email message to Julie Wilson and to your
PAC/SYP Seminar Leader.
Thank you.