Massachusetts Assent by Heirs at Law Form by iqe17486

VIEWS: 66 PAGES: 129

More Info
									Introduction to Protecting Human
     Subjects in Research

            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
                November 2002
       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 complete a questionnaire about the
research you are proposing to conduct.
Depending on your responses, you will receive
approval for your project or be instructed to make
a formal application to the KSG committee on the
use of human subjects in coursework.
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:
      • History
      • Ethical principles
      • Definitions of research involving human
      • 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.

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.

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

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:

For similar reasons, most federal agencies that
sponsor research involving human subjects have
mandated similar review systems for grantees.

Harvard’s system meets both the University’s
requirements and the federal requirements for prior
review of research involving human subjects.

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.

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.

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:                                                   History
  Jane Calhou
    Jane Calhoun:
               Principles Taken from the
      Jane Calhoun:

                   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
Jane Calhoun:
 Jane Calhoun:                                                   History
  Jane Calhou
    Jane Calhoun:
      Jane Calhoun:
              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.

          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.

Public Awareness

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
• LSD and Psilocybin research by Timothy Leary and Richard
• Research on obedience to authority by Stanley Milgram
• PHS-funded research on the natural course of untreated
  syphilis in Tuskegee

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
affected the
deliberative process.
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
A federal law was passed in 1956 banning all recording of jury

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.‖
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.

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 free-
wheeling and, in the opinion of many departmental colleagues,
rapidly lost any semblance of academic rigor.
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.

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 word-
pairing 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.
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.
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.

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.
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
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.

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
                                      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 self-
   determination; 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 and
institutions 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
                                              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.

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.

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

Research may also involve indirect
interactions, such as the analysis of
specimens or data
already obtained
from people (either
by you or by others).

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.

Intervention includes both physical
procedures for data gathering
and manipulations of
the subject or the
subject’s environment
that are performed for
research purposes.

Interaction includes communication or
interpersonal contact between
investigator and subject.

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.

Private information also includes
information that has been provided for
specific purposes by an individual, and
which the individual can
reasonably expect
                       Smith, John
will not be made
public (for example,
a school or medical
record or a loan

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.

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.

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.

Research involving human subjects?

Review of patients’ emergency room
records to determine the relationship
between age and type of traumatic injury.

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).

Research involving human subjects?

Videotaping a Memorial Day Parade to
determine later which groups provoked the
most enthusiastic spectator response.

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.

Research involving human subjects?

Collection of blood samples from needle
exchange program participants to determine
HIV status.

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

Research involving human subjects?

Interviewing Bruce Springsteen about the
songs he played on his recent concert tour.

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.

An Institutional Review Board (IRB)
is a federally-mandated committee
established to review and approve
research involving the use of human

There are three IRBs at Harvard, each a
standing committee of the faculty.

• 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
                       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
                       Ethical Principles

Federal rules regarding the
 use of human subjects in
                                     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.
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

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

– Ensures the confidentiality of subject data
– Immediately suspends research if any
  subject is injured, or if previously-
  unanticipated 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
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 previously-
  approved 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
                                  Roles & Responsibilities

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
• Publicizes human subjects policies and
  requirements to the research community
• Establishes and maintains appropriately-
  qualified IRBs
• Provides support for the IRBs and their
Special Issues
                             Special Issues

• Informed Consent
• Privacy, Confidentiality, and
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
• 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
• How your identity and privacy will be
                                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
                                            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.
and Anonymity
                                  Special Issues

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   Smith, John

 outside the context of the
 research project in a way
 that reveals or implies a
 subject’s identity.
                                Special Issues

Anonymity refers to the complete
absence of names or other identifying
 Data are anonymous if
 it is impossible for the
 investigator--or           X

 anyone else--to
 connect a subject with
 the data they've
                                        Special Issues

In the following situations, the data should
be kept confidential, but will usually not be
• 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
   – Use of narrow descriptive categories (―Asian
     male executive nurse in a healthcare
   – 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
                                      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
subjects, including
children, prisoners,
pregnant women, or
cognitively impaired
                                     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
  • 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
  • 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

  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

 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

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

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

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

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
                                       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     Smith, John

student revelation of
private information.
Special Categories
  of Research
     Special Categories of
• 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
Your IRB office can advise you on
whether your survey project will require
IRB review.
                            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
                             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
                              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

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
                                       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.

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 at
You may find it useful to bookmark the
location for easy reference.
You have completed the course.
  If you have a research project
  designed, you may now complete
  the human subjects questionnaire.

To top