Transcript HSRRC Education

The Protection of Human
Participants in Research
Instructions
• Please read the following presentation, which includes
reading “The Belmont Report ” and reviewing the
Binghamton University’s “Investigator’s Guide to Human
Participants Research.” Please forward the completed
Human Participants Education Review questions (located
at the end) to [email protected]
• If you experience technical difficulties, please contact
Anne Casella at 777-3918 or [email protected]
The Protection of Human
Participants in Research
A Basic Introduction
Introduction
Binghamton University is committed to protecting the
rights and welfare of human participants in research.
The information contained in this tutorial is provided
not only to comply with the federal regulations, but also
to educate researchers, research compliance staff,
Human Subject Research Review Committee
(HSRRC) members, and the Binghamton University
community as a whole, about the general principles for
ethical conduct in all human participants research.
Introduction
The Office for Human Research Protections (OHRP), U. S.
Department of Health and Human Services, was established
in 2000 to oversee human participants protections. In an effort
to educate individuals who conduct or review human
participants research, OHRP requires all institutions to
provide an educational training program on the ethical
conduct of human participants research.
Introduction
ALL PRINCIPAL INVESTIGATORS AND THEIR KEY
PERSONNEL, COMPLIANCE ADMINSTRATIVE STAFF,
APPROPRIATE INSTITUTIONAL SIGNATORY OFFICIALS,
AND INSTITUTIONAL REVIEW BOARD MEMBERS ARE
REQUIRED TO COMPLETE THIS TRAINING COURSE
PRIOR TO CONDUCTING OR REVIEWING RESEARCH
INVOLVING HUMAN PARTICIPANTS.
Definitions
Human Participants Research : A systematic Investigation,
including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge, which involves
the collection of data from or about living human beings.
Human Participants : A living individual about whom an
investigator conducting research obtains (1) data through
intervention or interaction with the individual, or (2) identifiable
private information.
Definitions
• Intervention: Includes both physical procedures by which data are
collected AND manipulations of the subject’s environment that are
performed for research purposes. This includes communication or
interpersonal contact between investigator and subject.
• Identifiable: The identity of the subject is or may readily be ascertained
by the investigator or associated with the information.
• Private information: Information about behavior that occurs in a
context in which an individual can reasonably expect that no observation
or recording is taking place, and information which has been provided for
specific purposes by an individual and which the individual can
reasonably expect will not be made public.
Ethical Principles
“The protection of human participants in research is not
about complying with regulations, but about conducting
research according to basic ethical principles.”
Greg Koski, Director OHRP
The basic ethical principles guiding human participants
research, are contained in a document entitled “The Belmont
Report ”
– Prepared by The National Commission for the Protection of
Human participants of Biomedical and Behavioral Research April 18, 1979.
The Belmont Report
The Belmont Report identifies three basic
ethical principles that underlie the conduct of
research involving human participants:
– Respect for Persons
– Beneficence
– Justice
You are required to read this document in
order to complete this course!
The Belmont Report
Respect for persons is the recognition of personal dignity and
autonomy of individuals, with special protection for those with
diminished autonomy. This is the basis for the informed consent
process, and respect for privacy.
Beneficence is the obligation to protect persons from harm by
maximizing anticipated benefits and minimizing risks or harm.
Justice mandates the selection of participants be fair to all (equitable
selection of participants). Researchers should not place the burden of
risk on one population with no anticipated benefit to that population,
or unfairly target a specific population due to “easy access”. Use of
good inclusion/ exclusion criteria is essential.
The Belmont Report
No one of these principles is more important than
the others.
No one should conduct human subject’s research
without reading the Belmont Report.
Additional Ethical Codes
The Nuremberg Code – A set of standards developed in 1947, as
a result of the atrocities against humans during WWII by German
researchers.
– Provided the first codification of ethical guidelines for the conduct
of research involving human participants.
– Although these were considered medical experiments, the
lessons learned also relate to social and behavioral research.
– The Code states that: consent must be voluntary and freely
given; the benefits of the research must outweigh risks; and
participants maintain the ability to terminate participation at any
time.
Additional Ethical Codes
Declaration of Helsinki
– Drafted by the World Medical Association, 1964.
Revised 1975, 1983, 1989, 1996, 2000.
– Elaborated on the principles in the Nuremberg Code.
“… considerations related to the well-being of the human subject
should take precedence over the interests of science and society”
Regulations
The Code of Federal Regulations (45 CFR 46) are
“minimum standards” of ethical conduct in human
participants’ research.
The regulations contain three basic protections for
human participants:
– Institutional Assurances
– IRB Review (HSRRC at Binghamton University)
– Informed Consent
Regulations
DHHS regulations include additional protections for vulnerable
populations as Subparts of 45 CFR 46:
– Subpart C - Additional DHHS Protections Pertaining to
Biomedical and Behavioral Research Involving Prisoners as
participants; Refer to page 46 of the Investigator’s Guide .
– Subpart D - Additional DHHS Protections for Children Involved as
participants in Research. Refer to pages 53 – 59 of the
Investigator’s Guide .
Regulations
The Federal Policy for the Protection of Human participants
(Common Rule) was adopted on June 18, 1991 and covers
research supported by the Departments of Agriculture, Energy,
Commerce, HUD, Justice, Defense, Education, Veterans
Affairs,Transportation, and HHS, as well as NSF, NASA, EPA, AID,
Social Security Administration, CIA, and the Consumer Product
Safety Commission.
The provisions of the Common Rule are identical to the DHHS
Regulations (45 CFR 46, Subpart A).
Regulations
New York State Law
– Article 24, The Public Health Law (Protection of Human
Participants) is the New York State law that states “… its policy of
this state to protect its people against the unnecessary and
improper risk of pain, suffering or injury resulting from human
research conducted without their knowledge or consent”.
University Policy
Binghamton University’s Human Subject Research Review
Committee (HSRRC), located in DSON/AB-116, is charged with the
protection of human participants in research. University policy
states that ALL research conducted under the auspices of the
University is reviewed by the HSRRC. This includes unfunded,
privately funded, and federally funded research. It also includes
class projects.
No human participants research, including recruitment of
participants, may begin until HSRRC review and approval is
obtained.
Institutional Assurances
Binghamton University has a Federal-Wide Assurance (FWA)
with OHRP, which assures compliance with federal regulations
(45 CFR 46) and state law (Article 24A, Public Health Law). In
addition, it requires the University to adhere to the ethical
principles of “The Belmont Report”. Under the FWA, the
University must:
- Designate one or more Institutional Review Boards (IRB), to
review and approve all human participants research,
- Provide sufficient space and staff to support the IRB’s review
and record- keeping duties, and
- Establish education and oversight mechanisms.
HSRRC Review
Human Subjects Research Review Committee (HSRRC) : A
campus- wide committee charged with the review of human
participants research to assure adequate methods of informed
consent and determine acceptable balance of risk/ benefit. (Do the
benefits of the research outweigh any risks imposed on the
participants?)
Why do we need HSRRC review?
– It may be difficult to be objective about your own work.
– People can underestimate the risks involved in things they are
very familiar with.
– People sometimes overestimate the benefit of things that are
important to them.
HSRRC Review
Criteria for HSRRC Review:
For submission procedures, read:
• HSRRC Review Process
• Investigator’s Checklist
– Satisfactory Risk/ benefit ratio
– Equitable selection of participants
– Satisfactory Informed consent process
– Adequate Privacy and confidentiality guarantees
Risk
The determination of risk requires evaluating both the magnitude
of potential harm to participants and the likelihood of the
occurrence of that harm.
Minimal Risk : the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of
themselves than that ordinarily encountered in daily life or during
the performance of routine physical or psychological
examinations or tests.
Risk
In order to approve research, the HSRRC must:
• Identify risks
• Determine that risks are minimized
• Determine that “risks to participants are reasonable in relation to
anticipated benefits”
• Determine that participants are adequately informed about “any
reasonably foreseeable risks or discomforts”
Research Risks
In addition to the physical risks inherent in bio-medical research,
social and behavioral research also may include risks such as:
– Emotional distress
– Psychological Trauma
– Embarrassment
– Loss of employment – financial loss
– Social stigmatization
– Shame or guilt
– Invasion of privacy
– Breach of confidentiality
Adverse Event
Adverse events are events that are unfavorable, harmful, or
detrimental to the welfare of participants. These events are
either unanticipated or anticipated but at a higher level or
greater frequency than expected.
All adverse events must be reported to the HSRRC immediately.
– An investigator studying a sensitive topic might expect some
participants to experience temporary distress while being interviewed,
but if half the participants get so upset they can not continue or the
interviewer has trouble getting them to calm down, this would be an
adverse event that should be reported to the HSRRC and may lead
to modifications in the data collection instrument.
Informed Consent Process
Informed consent is one of the primary ethical principles governing
human participants research. It assures that prospective human
participants understand the nature of the research, and voluntarily
decide whether or not to participate.
Informed consent is not a single event or form to be signed; it is an
educational process that takes place between the investigator and
the prospective participant.
Written consent forms, signed by the participant (or representative),
are merely documentation of “legally effective informed consent”.
Definitions
Consent: Legally effective agreement to participate in the
research by the participant or the participant’s legally authorized
representative based on the information that is given to the
participant or the representative in language that is
understandable.
Assent: Child’s affirmative agreement to participate in research.
Permission: An agreement of parent( s) or legal guardian to the
participation of their child or ward in research.
Consent Process
During the consent process, investigators must be absolutely certain
that all potential participants fully understand the information being
provided to them, and any and all potential risks due to their
participation in the research.
• Participants must have the capacity to understand the information
presented. For those with diminished capacity, legal surrogate consent
must be obtained.
• To maintain autonomy (as stated in the Belmont Report), participation
must be freely given, free from coercion or undue influence of others.
• Investigators must consider the possibility of obtaining consent from
any “third parties” involved if personally identifiable, sensitive
information is being obtained about them.
Consent Process
Information provided to participants in the informed consent process
must include:
• Identification of investigator by name and professional affiliation.
• Description of the research – including procedures to be used,
what is expected of participants, purpose of the study, and how
participants were selected for participation.
• Description of risks – participants are to be fully informed of all
anticipated/ potential risks involved with their participation, and how
the investigator will minimize these risks.
Consent Process
• Description of benefits – what is to be gained by the research–
whether to the individual or society,
• Explanation that participation is voluntary , participants are
free to discontinue at any time without penalty, or refuse to
complete any portion of the study,
• Explanation of procedures to maintain confidentiality/
anonymity and
• Provide points of contact for information on study, rights as
participants, or referral information
Participant Recruitment
• Recruitment of participants is a completely separate process from the
informed consent process.
• Recruitment of participants must not begin until the HSRRC has
reviewed and approved the procedures.
• Recruitment must include equitable selection of participants, which
does not place the burden of risk, without any anticipated benefit on
one population. Whenever possible, research should be designed to
encourage the participation of all groups while protecting their rights
and welfare.
• If certain specific groups are targeted, e. g. women, whites,
heterosexuals, a justification must be provided.
.
Participant Recruitment
• Recruitment must never include coercion or undue force. Even when
risks are reasonable and informed consent is obtained, it may be wrong
to solicit certain people as participants. Those who are not fully capable
of resisting the request to become participants – such as prisoners and
other institutionalized or otherwise vulnerable populations – shouldn’t
be enrolled just because they are easily accessible. In certain types of
research, participants should be selected based on the relevance of
their experiences to the subject at hand. Investigators should guard
against making promises to participants that they may not be able to
fulfill, such as publication, or benefits to the participant, just to have the
participant agree to participate.
• Investigators who hold power over potential participants must be
especially careful to avoid coercion or undue influence.
Participant Recruitment
This is not to say that teachers, supervisors, or physicians may
never request participation, but that procedures must be in place to
minimize the coercive nature of recruitment.
-For example, the teacher may request participation of students after
grades have been posted, or at the end of the school year. Written
surveys could be completed anonymously in a private area, or
recruitment done by someone other than the supervisor or physician.
The difference between the research and normal activities must be
made clear in these situations.
Social & Behavioral Research
Invasion of privacy may be unintentional. For example, the discovery of illegal
behaviors can occur even in studies not addressing the topic, or specifically asking
the question. In open- ended interviews, focus groups, or observations,
participants may unintentionally disclose sensitive information. An investigator
may not be required to report these discoveries, however the data could possibly
be subpoenaed. In some cases, The Department of Health and Human Services
provides “ Certificates of Confidentiality ” which protects this research data from
being subpoenaed.
• One of the most important risks in socially sensitive research is the effect of a
breach of confidentiality . An investigator must make every effort to ensure
confidentiality. Investigators are strongly urged to use anonymity whenever
possible.
Social & Behavioral Research
• In research where focus groups are utilized, breach of confidentiality is a
critical issue. The investigator cannot absolutely guarantee that whatever
the participant says during the group discussion will not be discussed
outside the group by the other members. Time should be taken, prior to the
beginning of the session, for the investigator to discuss the importance of
maintaining confidentiality. Limits to confidentiality must be noted in the
consent process used for each participant.
• In organizational or workplace research, the potential for an individual to
suffer financial loss, loss of job status, and/ or insurability is possible.
If an organizations authority figure is requesting the participation of
subordinates, the subordinate may feel if they do not “cooperate” with the
request, their standing within the organization may be jeopardized, or they
may be passed over for the next promotion or pay raise, or even lose their
job.
Historical Examples and Recent Events
Recent events have raised public concern about research ethics. To
maintain the public’s trust, the protection of the rights and welfare of
human participants must be of utmost importance while conducting
research. Violations in research ethics are generally caused by the
lack of awareness rather than malice. This has prompted government
action affecting the conduct and review of human participants
research.
The following are examples of what can happen if a researcher does
not conduct research in the ethical fashion outlined in the Belmont
Report.
The Milgram Study
The Milgram Study is a historical example of psychological risk
possible with social and behavioral research. Stanley Milgram,
who conducted this study and published the results in 1963, was
interested in obedience and human response to authority.
Researchers recruited volunteers by telling them the purpose was
to study memory and learning. However, the real intent was to see
how far the participant could be punished by complying with
authority.
The Milgram Study
Participants punished “students” (who were actually confederates of
the researcher) through administration of increasing levels of
electric shock.
Even though no shocks were actually administered, the “students”
pretended to show severe pain.
Experimenters pressured participants to continue to increase shock
levels beyond the level marked “dangerous” and to complete the
experiment.
Issues:
• Discovering unexpected personal weaknesses
• Shame or guilt feelings
• Deception
Tea Room Trade Study
In the early 70’s, a PhD. Candidate in sociology at Washington
University in St. Louis collected information about homosexual
practices in public restrooms.
The researcher went undercover by stationing himself in “tea
rooms” (as the restrooms were referred to), and acted as a look
out (“ watch queen” – the individual who keeps watch and
coughed when the police car came by or a stranger was
approaching).
Tea Room Trade Study
The researcher secretly followed some of the men he observed
and recorded their license plates. He then took a job at the
Department of Motor Vehicles and obtained the names and
addresses of these men.
A year later, he disguised himself, and appeared at their homes
claiming to be a health service interviewer and interviewed them
about their marital status, jobs, etc.
Tea Room Trade Study
The researcher’s findings destroyed many stereotypes and were
responsible for reducing the number of arrests for this crime. The gay
community praised his work, since the findings were positive in their
view.
However, the fact remained that he spied on participants and risked
subpoena of his data and the arrest of his participants. A large portion
of these men were married, living with their wives, were neither
bisexual or homosexual, or were fathers.
Issues:
 Deception
Participants included without their consent
Risk of financial loss, social stigmatization
VCU Twin Study
A researcher from Virginia Commonwealth University (VCU)
sent out a 25 page questionnaire to all twins in the state, which
solicited information for the Mid-Atlantic Twin Registry.
The questionnaires solicited sensitive information not only
about the twins but also about family members.
The father of one of the twins was angered that his daughter
was being asked to provide sensitive information about HIM
without his explicit permission.
VCU Twin Study
Subsequently, he filed a complaint the the Office for the Protection from
Research Risks (now OHRP). The father stated that this was a “total
invasion of privacy”, and added that release of this information could
revoke his security clearance at the Dept. of Defense if he was reported
as suffering from conditions such as mental illness.
OPRR determined that the IRB “did not consider that the study included
the collection of individually-identifiable, private information on family
members without their consent, thereby violating the Common Rule”.
Issues:
 Failure to obtain consent from available third parties
 Potential invasion of privacy
 Risk of financial loss, social stigmatization
Lead Paint Study
The Maryland Court of Appeals criticized a lead paint study
conducted in Baltimore being overseen by John Hopkins University
and likened the study to the Tuskegee Syphilis Study decades ago.
The Tuskegee Study, conducted from 1932 to 1972, was a medical
research project conducted by the U. S. Public Health Service to
examine the natural course of untreated syphilis in black American
men. Participants were not told they had syphilis, nor were they
offered an effective treatment when it became available.
Lead Paint Study
The lead-paint study was conducted in the early 1990’s to test
how well different levels of repair in Baltimore rental housing
worked to reduce lead in the blood of inner-city children.
Rental homes received differing levels of maintenance and
repairs to reduce lead levels. The researchers encouraged
landlords to rent to families with young children. Children already
living in the houses were encouraged to remain, so that their
blood levels could be analyzed.
Lead Paint Study
A lawsuit was filed by two of the mothers, saying that the research
institute had failed to warn them about the risks of the study and the
danger that their children could be poisoned by lead in the houses.
Issues:
 Lack of fully informed consent
 Recruitment coercion
 Use of vulnerable population and minors without added protections
Columbia University Restaurant Study
In 2000, a Columbia University professor of Organizational
Behavior sent fictitious letters, on Columbia University letterhead,
to 240 New York restaurants, stating that he had contracted food
poisoning after eating in their establishment. In sending the letter,
the professor was seeking to find out how business owners
would respond to polite customer complaints versus how they
would respond to angry complaints.
Columbia University Restaurant Study
The professor did not intentionally set out to create the chaos the
survey caused among restaurants, but never thought through the
ramifications such a letter would cause. Many of the restaurant
owners spent many hours and large amounts of money trying to first
find the customer, then to find out the source of the food poisoning.
Several hours were spent questioning employees, throwing away
food, and money was spent to clean their establishments.
One restaurant owner was cited as saying that because this came
from such a “prestigious institution”, it would be the “kiss of death” to a
restaurant if such information became public.
Columbia University Restaurant Study
This study was never presented to the University’s IRB, which
presumably would have considered the deception involved and the
potential for harm (stigma, loss of reputation, financial loss) before
approving the study.
Issues:
 Deception
 Participants included without their consent
 Risk of financial loss, social stigmatization
Recent Death in Research
Ellen Roche, a technician employed at the Johns Hopkins University
Asthma and Allergy Center, died on June 2, 2001, one month after
participating in a study run by an asthma specialist to test a theory
about what happens during an asthma attack.
Ms. Roche was a normal, healthy volunteer.
Issues:
 Was there coercion in the recruitment of an employee?
 Was the payment to participant coercive? (excessive compensation)
 Was the participant not fully informed of the risks involved in
participation?
Recent Death in Research
On September 17, 1999, an 18 year old boy, Jesse Gelsinger, died as a
result of his participation in a gene therapy trial at the University of
Pennsylvania.
Mr. Gelsinger was not fully informed about previous adverse reactions in
this study and may not have met the inclusion criteria for the study.
The researcher was a major stockholder in the biotechnology company
funding the study as was the university.
Issues:
 Lack of fully informed consent – did not include full disclosure of risks
 Questions about whether this participant qualified for the experiment
(inclusion/ exclusion criteria)
 Conflict of interest
Required Reading
The Belmont Report
Investigator’s Guide to Human Participants
Research
It is recommended that you download both of these
documents for future reference!
It is suggested that investigators refer to any code
of professional ethics in their disciplines.
Binghamton University Compliance
Human Subjects Research Review Committee
Binghamton, BY 13902-6000
(607) 777- 3818 - phone
(607) 777- 5025 – fax
[email protected]
http://humansubjects.binghamton.edu
Summary Questions
Instructions:
– Please download the Human Participants Education Review
questions.
– Answer the questions and forward to the HSRRC Office,
[email protected] Binghamton University IPPH/AB-116
– A Certificate of Completion will be forwarded to you.