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Research Participation. History, Informed Consent, Participation, Protection. Why I Believe 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

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research participation

Research Participation

History, Informed Consent, Participation, Protection

slide2
Why I

Believe in

Research…

Barbara’s

Story

Listen to Barbara’s personal story….

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

slide3
What

Is

Research?

research definitions facts and examples
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 examples1
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 examples2
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 examples3
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
research protections
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 and application
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 application1
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 application2
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 application3
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 application4
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
slide18
History of

Regulations

Governing

Research

history of regulations governing 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 research1
History of Regulations Governing Research

Ethical Codes

  • Nuremburg Code

http://www.ohrp.osoph.dhhs.gov/irb/irb_appendices.htm

  • The World Medical Association Declaration of Helsinki

http://www.wma.net/e/policy/17_c_e.html

  • The Belmont Report

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

history of regulations governing research2
History of Regulations Governing Research

Other

  • Congressional hearings
  • National Research Act of 1974
  • Common Rule

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

slide22
What is

the Institutional

Review Board

(IRB)?

institutional review 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 irb1
Institutional Review Board (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
How Is Research Approved?

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
how is research approved1
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 protection
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
informed consent
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 consent1
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 consent2
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
questions to 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?
slide36
Important

Reminders

important reminders
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:
    • Parent
    • Grandparent
    • Child
    • Brother or Sister
    • Friend
research participation1
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