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

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
Examples of Activities That May Be Research



Testing new treatments
(drugs, devices)
Review and analysis of
existing data
Testing new educational
materials

Interviews

Focus groups

Surveys

Observations
RESEARCH DEFINITIONS, FACTS AND EXAMPLES
Examples of Vulnerable Research Subjects



Pregnant women, fetuses,
and neonates

Racial and ethnic minorities

The very sick
Persons with diminished
decision-making capacity

College students

Prisoners
Economically or
educationally
disadvantaged persons

Children

Institutionalized persons
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
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 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
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 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 RESEARCH
Other

Congressional hearings

National Research Act of 1974
Common Rule
http://www.hhs.gov/ohrp/humansubjects/guidance/4
5cfr46.htm

What is
the
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 (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 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)

Office for Human Research
Protections (OHRP)

Institutional Review
Boards (IRBs)

Food and Drug
Administration (FDA)

Office for Civil Rights (OCR)

Researchers

Departments of Defense,
Education, Justice, and
Veterans Affairs

Data Monitoring
Committees
What is
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 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?
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
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