the protection of human participants in research instructions

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.

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.

DefinitionsDefinitions

• 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.

Definitions

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.

.


• 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.


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).


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.


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


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.


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.


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


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.

the protection of human participants in research instructions

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