RESEARCH PARTICIPATION

History, Informed Consent, Participation, Protection

Why IBelieve in Research…Barbara’s

Story

Listen to Barbara’s personal story….http://orrp.osu.edu/irb/participants/

What Is

Research?

RESEARCH DEFINITIONS, FACTS AND EXAMPLES

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

RESEARCH DEFINITIONS, FACTS AND EXAMPLES

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.

RESEARCH DEFINITIONS, FACTS AND EXAMPLES

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

RESEARCH DEFINITIONS, FACTS AND EXAMPLES

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?

WHY SHOULD I PARTICIPATE IN RESEARCH?

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?

RESEARCH PROTECTIONS

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

andApplication

ETHICAL PRINCIPLES AND APPLICATION

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

ETHICAL PRINCIPLES AND APPLICATION

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

ETHICAL PRINCIPLES AND APPLICATION

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

ETHICAL PRINCIPLES AND APPLICATION

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

ETHICAL PRINCIPLES AND APPLICATION

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 RegulationsGoverning Research

HISTORY OF REGULATIONS GOVERNING RESEARCH

Historical Injustices

1932 – 1972 Tuskegee Syphilis Study

1941 – 1945 Nuremberg Trials

1950s Willowbrook Hepatitis Studies

1955 Wichita Jury Trial

1960s Milgram Studies of Obedience to Authority

1962 Thalidomide Experience

HISTORY OF REGULATIONS GOVERNING RESEARCH

Ethical Codes

Nuremburg Codehttp://www.ohrp.osoph.dhhs.gov/irb/irb_appendices.htm

The World Medical Association Declaration of Helsinkihttp://www.wma.net/e/policy/17_c_e.html

The Belmont Reporthttp://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

HISTORY OF REGULATIONS GOVERNING RESEARCH

Other

Congressional hearings

National Research Act of 1974

Common Rulehttp://www.hhs.gov/ohrp/humansubjects/guidance/

45cfr46.htm

What is the

InstitutionalReview Board(IRB)?

INSTITUTIONAL REVIEW BOARD (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.

INSTITUTIONAL REVIEW BOARD (IRB)

IRB Member Composition:Scientists and non-scientists; affiliates and non-affiliatesDifferent backgrounds and experienceKnowledge of their community Knowledge of research protections

IRB Member Roles:ChairVice ChairMemberConsultant

How is Research

Approved?

HOW IS RESEARCH APPROVED?

The following requirements must be met before the IRB can approve research:

Risks to participants are minimizedRisks are reasonable in relation to the expected benefitsSelection of participants is fair and unbiased Informed consent is sought and obtained from potential

participants or their legal representatives

HOW IS RESEARCH APPROVED?

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

PARTNERS IN PROTECTION

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 InformedConsent?

INFORMED CONSENT

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.

INFORMED CONSENT

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

INFORMED CONSENT

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?

QUESTIONS TO ASK

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?

ImportantReminders

IMPORTANT REMINDERS 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:ParentGrandparentChildBrother or SisterFriend

Research Participation

RESEARCH PARTICIPATION

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.

http://orrp.osu.edu/irb/participants

Questions