R ESEARCH P ARTICIPATION History, Informed Consent, Participation, Protection

Why I Believe in Research… Barbara’s Story Listen to Barbara’s personal story….

What Is Research?

R ESEARCH D EFINITIONS, F ACTS AND E XAMPLES Definitions Research: an investigation designed to develop or contribute to generalizable knowledge (e.g., fact, theory, application); collecting and breaking down data in the hopes of answering a question Human subject: a living individual about whom researcher obtains (1) Data through intervention or interaction, or (2) Identifiable private information

R ESEARCH D EFINITIONS, F ACTS AND E XAMPLES Facts Federal regulations define when an activity is research involving human subjects. All research involving human subjects must be approved by an Institutional Review Board (IRB) or determined to be exempt (released from review requirements) before any activity is performed.

R ESEARCH D EFINITIONS, F ACTS AND E XAMPLES Testing new treatments (drugs, devices) Review and analysis of existing data Testing new educational materials Interviews Focus groups Surveys Observations Examples of Activities That May Be Research

R ESEARCH D EFINITIONS, F ACTS AND E XAMPLES Pregnant women, fetuses, and neonates Persons with diminished decision-making capacity Economically or educationally disadvantaged persons Racial and ethnic minorities The very sick College students Prisoners Children Institutionalized persons Examples of Vulnerable Research Subjects

Why Should I Participate in Research?

W HY S HOULD I P ARTICIPATE IN R ESEARCH ? Participating in research: Increases your knowledge and awareness Impacts others by contributing to research discoveries Helps researchers understand disease, behavior, and learning processes Contributes to society’s medical, intellectual, and social progress

What Is Research Protection?

R ESEARCH P ROTECTIONS The moral obligation to protect participants is a group effort involving researchers, funding organizations, and Institutional Review Boards (IRBs). This obligation involves acting with concern and respect for all participants. Important tools for providing protection include: education, certification, and accreditation.

Ethical Principles and Application

E THICAL P RINCIPLES AND A PPLICATION There are three basic principles outlined in the Belmont Report that are central to the ethics of research involving human subjects and to guiding Institutional Review Boards in ensuring that the rights and welfare of research participants are protected: Respect for persons Beneficence Justice

E THICAL P RINCIPLES AND A PPLICATION Principle: Respect for persons Individuals should be given free choice in their decisions to participate Persons with limited independence (e.g., children, mentally disabled adults) are entitled to protection

E THICAL P RINCIPLES AND A PPLICATION Application: Informed Consent Participants must be given the opportunity to choose what shall or shall not happen to them to the degree that they are capable The consent process must be informative, understandable, and clearly state that participation is a choice

E THICAL P RINCIPLES AND A PPLICATION Principle: Beneficence Participants should not be harmed Research should maximize possible benefits and minimize possible harms Application: Assessment of Risks and Benefits The nature and range of risks and benefits must be considered

E THICAL P RINCIPLES AND A PPLICATION Principle: Justice The benefits and risks of research must be distributed fairly Application: Selection of Participants There must be a fair and impartial selection process Participants should be treated fairly Benefits and burdens are shared fairly

History of Regulations Governing Research

H ISTORY OF R EGULATIONS G OVERNING R ESEARCH Historical Injustices 1932 – 1972Tuskegee Syphilis Study 1941 – 1945Nuremberg Trials 1950sWillowbrook Hepatitis Studies 1955Wichita Jury Trial 1960sMilgram Studies of Obedience to Authority 1962Thalidomide Experience

H ISTORY OF R EGULATIONS G OVERNING R ESEARCH Ethical Codes Nuremburg Code The World Medical Association Declaration of Helsinki The Belmont Report

Other Congressional hearings National Research Act of 1974 Common Rule 5cfr46.htm

What is the Institutional Review Board (IRB)?

I NSTITUTIONAL R EVIEW B OARD (IRB) IRBs were established to protect the rights and welfare of humans participating in research. IRBs must receive enough information from researchers to provide a proper review of proposed research and to make the necessary decisions required by regulations for IRB approval. Review and approval are required before any study can begin. Continuing reviews, at least yearly, are required while the study is ongoing.

I NSTITUTIONAL R EVIEW B OARD (IRB) IRB Member Composition: Scientists and non-scientists; affiliates and non-affiliates Different backgrounds and experience Knowledge of their community Knowledge of research protections IRB Member Roles: Chair Vice Chair Member Consultant

How is Research Approved?

H OW I S R ESEARCH A PPROVED ? The following requirements must be met before the IRB can approve research: Risks to participants are minimized Risks are reasonable in relation to the expected benefits Selection of participants is fair and unbiased Informed consent is sought and obtained from potential participants or their legal representatives

H OW I S R ESEARCH A PPROVED ? The following requirements must be met before the IRB can approve research (cont.): Plans are in place to protect the privacy of participants and to maintain the confidentiality of data Resources are available to monitor the data collected and to ensure the safety of participants, as appropriate to the degree of risk Additional safeguards are provided for vulnerable populations

Partners in Protecting Your Rights

P ARTNERS I N P ROTECTION Department of Health and Human Services (DHHS) Institutional Review Boards (IRBs) Office for Civil Rights (OCR) Departments of Defense, Education, Justice, and Veterans Affairs Office for Human Research Protections (OHRP) Food and Drug Administration (FDA) Researchers Data Monitoring Committees

What is Informed Consent?

I NFORMED C ONSENT Federal laws require that individuals who are considering participating in a study are given information about the study and time to think about if they want to be in the study. This process is called “informed consent.” Consent forms are to be written so people understand them. People should always ask questions before agreeing to be in a study.

I NFORMED C ONSENT Informed consent must include information about: The nature and purpose of the research What will go on in the study Which parts of the study are experimental How long the study is expected to take Possible risks or discomforts Possible benefits

I NFORMED C ONSENT Informed consent must include information about: Options that may exist besides being in the study Where you can get help if you are harmed from being in the study Contact information for questions Your choice to take part in the study Your ability to leave the study at any time and for any reason

What Questions Should I Ask?

Q UESTIONS TO A SK How many other people are in the study? Will there be any costs for me? Will my records be kept private? What will happen at the end of the study? Will I get a copy of the study results? Will I still get paid even if I leave the study early? Will there be follow-up?

Important Reminders

I MPORTANT R EMINDERS Participation must not involve someone taking advantage of another due to his/her position of power. Participation must not involve force, persuasion, threat, or violence. Study participants are someone’s: Parent Grandparent Child Brother or Sister Friend

Research Participation

R ESEARCH P ARTICIPATION OSU hosts a research participant page on the IRB website. This page provides links to university departments that maintain lists of active research projects and educational links related to research involving human subjects. Research participants are invited to contact ORRP to provide feedback and/or obtain information.

Questions