Transcript Institutional Review Board University of Texas at El Paso

Christian A. Meissner, Ph.D.
Chair, Institutional Review Board
University of Texas at El Paso
What is the IRB?
The Institutional Review Board (IRB) is a committee
representing various research disciplines that oversees
all research involving human subjects conducted by
faculty, students, or staff who might use any University
property or non-public information to contact human
research subjects.
Why is the IRB important?
Federal law (45 CFR 46) and the Assurance document
signed by Universities and the Office for Human
Research Protections (OHRP) require that an IRB be
established to review all studies involving human
subjects (both funded and unfunded protocols).
Failure to comply with these regulations could lead
to a suspension of all university research activities
involving human subjects and a loss of federal funding.
The Belmont Report…
The Belmont Report was issued April 18, 1979, after
a conference held in February 1976 at the Smithsonian
Institution’s Belmont Conference Center in Maryland.
The repot identified three basic ethical principles that
should govern human subject research, specifically:
• Respect for Persons
• Beneficence
• Justice
Respect for Persons
Each research subject is an individual capable of
making up his or her own mind about whether to
participate in a research study. Research subjects that
have a diminished capability (whether they are
immature, incarcerated or incapacitated) are
vulnerable and they receive special protection under
federal law (45 CFR 46).
Beneficience
Comes from the Hippocratic maxim “do no harm.”
Subjects in a research study should be protected from
research risks, have their decisions respected and their
well-being assured. Researchers need to maximize
possible benefits and minimize possible risks to
subjects.
Justice
Implies that subjects should be selected equitably.
No one group of subjects, such as the economically
disadvantaged or the institutionalized, should
continually bear the burden of research.
Three Important Issues to Consider
when Conducting Research…
• Informed Consent
• Use of Deception
• Confidentiality & Data Protection
Informed Consent…
It is a process, not a document!
Informed Consent…
(1) purpose of the research, the likely duration, and
relevant procedures
(2) right to decline to participate and to withdraw
from the research once participation has begun
(3) factors that may be expected to influence the
willingness to participate such as potential risks,
discomfort, or adverse effects
Informed Consent…
(4) any prospective research benefits
(5) procedures for safeguarding confidentiality
(6) incentives for participation
(7) contact for questions about the research and
research participants' rights
Use of Deception…
Use of Deception…
•
Might the information to be withheld influence
prospective subjects’ decisions regarding
participation in the research?
•
Does the use of deception place the participant
at greater than minimal risk during the study?
•
Would the researcher be unable to scientifically
evaluate the phenomenon if the subject were
fully informed prior to participation?
Confidentiality & Data Protection…
Confidentiality & Data Protection…
•
Federal laws (such as HIPAA and FERPA) protect
the disclosure of individually identifiable health,
educational, and economic information
•
Issues of data confidentiality typically come into
play when biomedical, social or behavioral science
research involves data collection on identifiable
individuals. Protections should be developed
consistent with the study design and the potential
risk of harm from breaches of confidentiality.
Confidentiality & Data Protection…
•
What steps could you take to protect the
confidentiality of a participant?
•
How might you protect your data from
unauthorized access or distribution?
One last thought…
Even when clear ethical standards and principles
exist, there will be times when the need to do
accurate research runs up against the rights of
potential participants. No set of standards can
possibly anticipate every ethical circumstance.
As you work with your IRB to resolve such issues,
keep in mind the Belmont principles of Respect for
Persons, Beneficence, and Justice, and thoughtfully
place yourself in the subject’s position.
Thanks for your attention
and participation!
Christian A. Meissner, Ph.D.
Associate Professor of Psychology
Chair, Institutional Review Board
University of Texas at El Paso
Email: [email protected]
Telephone: 915-747-6056