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The Protection of Human Participants in Research Instructions.
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A Basic 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.
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.
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.
• 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.
“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 identifies three basic ethical principles that underlie the conduct of research involving human participants:
– Respect for Persons
You are required to read this document in order to complete this course!
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.
No one of these principles is more important than the others.
No one should conduct human subject’s research without reading the Belmont Report.
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.
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”
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
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 .
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).
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”.
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.
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.
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.
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.
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
– Loss of employment – financial loss
– Social stigmatization
– Shame or guilt
– Invasion of privacy
– Breach of confidentiality
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 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”.
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.
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.
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.
• 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
• 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.
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.
• 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.
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 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.
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.
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.
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.
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.
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.
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.
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.
Human Subjects Research Review Committee
Binghamton, BY 13902-6000
(607) 777- 3818 - phone
(607) 777- 5025 – fax
– Please download the Human Participants Education Review
– Answer the questions and forward to the HSRRC Office, firstname.lastname@example.org Binghamton University IPPH/AB-116
– A Certificate of Completion will be forwarded to you.