Ethical Considerations in Human Subjects Research Presenter: Dr. Debbiesiu L. Lee Associate Professor/ Associate Chair Educational and Psychological Studies Department School of Education and Human Development University of Miami

Outline and Purposes of Presentation Define human subjects research and Institutional Review Boards (IRB) Review the basic ethical principles of human subjects research Review the application of these ethical principles

Defining Research & Human Subjects Research Research is the systematic collection, analysis, and interpretation of data to answer a certain question or solve a specific problem. Human Subjects Research Any research that involves human beings as providers of information or data.

The Research Process Discovery of New Knowledge (research) Dissemination of Knowledge (publication, education) Application of Knowledge (translation of research to policies and practices in the community) The research process is not only the creation or discovery of new knowledge, but also the dissemination of that knowledge for wider consumption, including publication and education. As well as, when it comes to human subjects research, the application of this knowledge into policies and practices.

Why do we need Human Subjects Protection? Premises (1) Human subjects are essential to conducting research intended to improve human health and well- being. (2) The relationship between investigator/s and research participants should be based on trust, honesty, and respect. (3) Investigators (who design and implement research) should understand their obligations to protect the rights of research participants. Unfortunately, in our past, research has sometimes neglected the rights and well-being of participants, and so these protections were created as a result.

Institutional Review Boards (IRB) Institutional Review Boards are establishments (typically associated with institutions of higher learning) that are responsible for and oversee the protection of human subjects. IRBs are also responsible for ensuring that the investigators understand and fulfill their obligations to protect the rights and welfare of research participants. IRB monitors the research to ensure the rights and welfare of research participants. Institutional review boards were further created to ensure that human subjects were protected in research.

Basic Ethical Principles Guiding Human Subjects Research

Basic Ethical Principles Guiding Human Subjects Research Respect for Persons (respect people’s decisions, protect the vulnerable) (2) Beneficience (do no harm, do good) (3) Justice (treat people equitably)

1. RESPECT FOR PERSONS Individuals should be treated as autonomous agents. “Participants, to the degree that they are capable, should be given the opportunity to choose what shall or shall not happen to them.” Individuals with diminished autonomy are entitled to special protections. Children People who are mentally incapacitated Prisoners They should be fully informed about the research and should be able to make a free choice about whether or not they would like to participate in the research.

2. BENEFICENCE a. Do no harm b. Maximize potential benefits and minimize possible harms (risks).

3. JUSTICE (1) Individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research. (2) Investigators “should not offer potentially beneficial research only to some patients who are in their favor or select only ‘undesirable’ persons for risky research.” It should not be that one group of people suffer for research, and another group of people benefit.

Application of Ethical Principles Into Research Practices

APPLICATION OF ETHICAL PRINCIPLES INTO RESEARCH RESPECT FOR PERSONS: Informed Consent BENEFICIENCE: Assessment of Risks and Benefits JUSTICE: Selection of Participants

Informed Consent A legally-effective, voluntary agreement that is given to a prospective research participant following comprehension and consideration of all relevant information pertinent to a decision to participate in a study. (1) Information (2) Comprehension (3) Voluntariness Reduces the potential for coercion or undue influence . Thus, there are three components necessary in Informed Consent. (1) information, (2) comprehension, (3) voluntariness.

INFORMED CONSENT (1) Information Researcher should ensure that potential participants are informed of the research procedures, and potential risks and benefits of participating in the research. Coercion undue influence

INFORMED CONSENT (1) Information The purpose of the study Any reasonably foreseeable risks to the individual Potential benefits to the individual or others Alternatives to the research protocol The extent of confidentiality protections for the individual Compensation Contact information for questions regarding the study, participants’ rights, and in case of injury The conditions of participation, including right to refuse or withdraw without penalty.

INFORMED CONSENT (2) Comprehension Individuals must have the mental or decisional capacity to understand the information presented to them in order to make an informed decision about participation in research. Participants must be able to accurately comprehend (1) the risks and benefits associated with research, (2) weigh them according to their own opinions, beliefs, and values, and (3) should be able to take appropriate action.

INFORMED CONSENT (2) Comprehension Special Protections for Vulnerable Populations “Special provisions may need to be made when an individual’s comprehension is severely limited or when a class of research participants is considered incapable of informed decision making” children, people who are mentally incapacitated, prisoners. In some cases, respect for persons may require seeking the permission of other parties, such as a parent or legal guardian.”

Children’s Participation in Research Children may not have full capacity to make decisions in their own best interests; and therefore: Children are unable to provide “legally effective informed consent” Because children cannot provide informed consent, children provide assent to participate in research, to the extent that they are able, and parents/guardians give permission for a child to participate in research. Assent: “Affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.”

INFORMED CONSENT (3) Voluntariness Individuals’ decisions about participation in research should not be influenced by anyone involved in conducting the research: “...consent must be freely given or truly voluntary.” Avoiding influencing potential participants’ decisions either through (coercion) or through (undue influence)

INFORMED CONSENT (3) Voluntariness Coercion (threats) “Influencing an individual decision about whether or not to do something by using explicit or implied threats (loss of good standing in job, poor grades, etc.)”

INFORMED CONSENT (3) Voluntariness Undue Influence (Excessive rewards) “ An offer of an excessive, unwarranted, inappropriate, or improper reward or other overture in order to obtain compliance” “offers that are too attractive may blind prospective subjects to the risks or impair their ability to exercise proper judgment; and they may prompt subjects to lie or conceal information that, if known, would disqualify them from enrolling — or continuing — as participants in a research project.”

INFORMED CONSENT/ Voluntariness Undue Influence –vs- Compensation Some types of research involve a significant commitment from research participants in terms of time or effort, and investigators may wish to provide compensation. Compensation is meant to reimburse research participants for their time, research-related inconveniences, and/or research-related discomforts. Compensation is not a benefit of the research.

INFORMED CONSENT Obtaining Informed Consent Investigators should present informed consent in a manner that is understandable to the potential participants. Methods used in addition to a consent form to enhance individuals’ comprehension: Oral presentations (opportunity to discuss the information and ask questions), Providing additional educational materials, such as brochures, Video presentations.

INFORMED CONSENT Requirements for Documentation Informed consent must be documented using a written form that either contains all of the required elements, or a short form that states that all of the required elements have been presented orally. This form must be signed by either the participant or the participant’s legally authorized representative. Informed consent legally authorized representative

APPLICATION OF ETHICAL PRINCIPLES INTO RESEARCH RESPECT FOR PERSONS: Informed Consent BENEFICENCE: Assessment of Risks and Benefits JUSTICE: Selection of Participants

Assessment of Risks and Benefits Benefits Greater than Potential Harms Research requires that: Risks are minimized . Unavoidable risks are justified as necessary for sound scientific design. Research studies should provide important, new knowledge for society.

Assessment of Risks and Benefits Potential Risks in Research A. Physical Physical risks may include pain, injury, and impairment of a sense such as touch or sight. These risks may be brief or extended, temporary or permanent, occur during participation in the research or arise after. Should follow protocols to minimize risks.

Risk in Research (cont.) B. Psychological Psychological risks can include anxiety, sadness, regret and emotional distress, among others. Possible ways to protect against psychological risks: (1) reminding participants of their right to withdraw from research (2) limit their participation if they become uncomfortable (3) providing counseling or psychological support for participants who experience distress

Risk of Research (cont.) C. Social Social risks can range from jeopardizing the individual’s reputation and social standing, to placing the individual at-risk of political or social reprisals. Minimizing social risks to participants involves protecting confidential data.

Privacy and Confidentiality Protecting privacy of individuals Privacy means being “free from unsanctioned intrusion”. Do not ask more personal questions than needed to answer the research questions. Confidentiality of data Confidentiality means holding secret all information relating to an individual, unless the individual gives consent permitting disclosure Investigators

APPLICATION OF ETHICAL PRINCIPLES INTO RESEARCH RESPECT FOR PERSONS: Informed Consent BENEFICIENCE: Assessment of Risks and Benefits JUSTICE: Selection of Participants

3. Justice/ SELECTION OF PARTICIPANTS (1) Individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research. (2) Arises in decisions about inclusion and exclusion criteria for participation in research. (3) Investigators “should not offer potentially beneficial research only to some patients who are in their favor or select only ‘undesirable’ persons for risky research.”

INCLUSION/ EXCLUSION CRITERIA Equitable Distribution In order to achieve an equitable distribution of the risks and potential benefits of the research, Investigators must determine the distribution of different groups (men and women, racial or ethnic groups, adults and children). These should be reported.

References and Links: CITI. Collaborative Institutional Training Institute. https://about.citiprogram.org/en/homepage/ National Institute of Health. NIH Office of Extramural Research. Protecting Human Research Participants https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html Belmont Report https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/

Thank you!