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