Transcript Ethical Requirements of Research

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Introduction to Research Ethics
Requirements of Research Ethics
Institutional Review Board (IRB)
Systematic Review of Research Proposal
Case reviews
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Outline
Research Ethics
• Support and remind researchers to protect human
subjects.
• Provide us with a structure for analysis and decisionmaking.
• Provide workable definitions of benefits and risks,
along with guidelines for evaluating and balancing
the benefits and risks of our studies.
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Concepts of research ethics:
What is Research?
Definition of Research:
Definition of Human Subject:
• A living individual about whom an investigator
conducting research obtains
data through intervention or interaction with the
individual, or
identifiable private information (e.g. record review)
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• a systematic investigation designed to develop or
contribute to general knowledge.
Misconduct
Ethical Codes and Guidelines
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Why Research Ethics?
In 2004 and 2005, Dr. Hwang Woo-Suk,
published two papers in the journal
Science that claimed his team had
succeeded in creating human embryonic
stem cells through cloning. Allegations
later followed from a co-worker that these
paper was based on fabricated data.
The papers were editorially retracted, Dr.
Hwang lost his position at Seoul National
University, and the South Korean
government ended its financial and legal
support of his research.
http://www.nytimes.com/2009/10/27/world/asia/27clone.html?_r=1&ref=hwangwoosuk
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Famous Misconduct Cases
Stem Cell Case (2005-2006)
Nuremberg
Code (1949)
Declaration
Of Helsinki
(1964- 2000)
The Belmont
Report
(1979)
CIOMS/WHO
International
Guidelines (1993,
2002)
QU_IRB
(2011)
SCH (2010)
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Examples of Codes & Guidelines
In 1979 the National Commission published the
Belmont Report.
The Belmont Report identifies three basic ethical
principles that underlie all human subject research.
These principles are commonly called the Belmont
Principles. The Belmont Principles are:
 Respect for persons, Beneficence, and Justice.
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The Belmont Report
The Belmont Principles
• Respect for persons include:
• Beneficence Include:
• The requirement to use the best possible research design to
maximize benefits and minimize harms.
• The requirements to make sure the researchers are able to
perform the procedures and handle the risks.
• The prohibition of research that is without a favorable riskbenefit ratio.
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• The requirement to obtain informed consent.
• The requirement to respect the privacy of research subjects.
The Belmont Principles Con.
• The principle of justice include:
It was the Commission's intention that each of the three principles
should have equal moral force.
Researchers required to consider each case separately and on
its own merits in light of all three principles.
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• The requirement to select subjects equitably.
• The requirement to avoid exploitation of vulnerable populations or
populations of convenience.
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Community Partnership (Respect of culture)
Social value (valuable to research subject &
community)
Scientific validity (use of accepted scientific
methods)
Fair subject selection (inclusion & exclusion
criteria) (vulnerable groups)
Favorable risk-benefit ratio (Risk could be physical,
psychological, social, economical or legal )
Independent review (To avoid conflicts of interests)
Informed consent
Respect for human subjects
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Requirements of Research Ethics
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Levels of risks
Minimal
Above
minimal
Too
risky
Contents:
1. Purpose of the research
2. Procedures (duration)
3. Risks
4. Benefits
5. Alternatives
6. Confidentiality
7. Withdrawal
8. Compensation
9. Who will contact
Voluntary Decision
No pressure
No undueencouragement
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7-Informed Consent Process (cont)
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Samples
• IRB is a review committee established to help
protect the rights and welfare of human research
subjects. Regulations require IRB review and
approval for research involving human subjects.
Most research institutions, professional
organizations, and scholarly journals apply the
same requirements to all human research.
Although federal regulations refer to IRBs, an
institution may have chosen a different name for
the committee (Ethics Review Committee).
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Institutional Review Board (IRB)
IRB protects:
1- The research subjects
2- The researchers
3- The institutes
4-The community
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• The primary function of an Institutional Review
Board (IRB) is protection of human subjects
involved in research.
The Composition of the IRB
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At least five members.
Members of both sexes.
Members that come from varied professions.
At least one member whose primary concerns are in
nonscientific areas.
• At least one member whose primary concerns are in scientific
areas.
• At least one member who is not otherwise affiliated with the
institution.
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SCH regulations dictate that the IRB membership will
include:
SCH regulations stipulate that an IRB can:
• Approve research.
• Disapprove research.
• Modify research.
• Conduct continuing reviews.
• Observe/verify changes.
• Suspend or terminate approval.
• Observe the consent process and the research
procedures.
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The Authority of the IRB
Consequences of Not Following IRB
Regulations
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Suspension of research project.
Suspension of all of a PI's research projects.
Inability to use data or publish results.
Notification of sponsors, regulatory agencies and funding agencies of
noncompliance.
Inability to receive funding from federal grants.
Additional monitoring and oversight by the IRB and/or third party
monitoring of research activities.
Termination of employment.
Loss of licenses.
Immediate shut-down of ALL research at an organization.
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If IRB regulations are not followed, consequences
could include:
(Qatar University – Institutional
Review Board)
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QU-IRB
• Qatar University’s Institutional Review Board (QU-IRB), under
the directives of Supreme Council of Health (SCH) was formed
as an independent committee under research compliance in
September 2011. All research that is to be conducted on
human subjects must be submitted to QU-IRB for ethical
acceptability
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QU-IRB
General Procedures Outline
Part 1. (from Applicant)
• If both English and Arabic languages are to be used, supporting
documents such as surveys, questionnaires, consents/ascents, etc…,
should be provided in both languages.
• If exemption from Full Ethics Review is requested, it should be
specified in the email with reasons for such request.
• Exemption criteria is stated in the Research Ethics Detailed Manual
which can be accessed through QU-IRB Web Site
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Filled in forms (Application, Checklist and other supporting
documents) should be sent to QU-IRB at the email address [email protected]. (All forms are available in the Required Forms list)
General Procedures Outline
Cont.
• Step 2: Once step 1 is complete, the proposals are reviewed
by the chairperson for possible exemption or expedited. If ok,
the exemption letter is issued without sending the application
for a full ethics review.
• Step 3: If the application does not meet the exemption
requirements, it undergoes a full ethics review. Once approval
is granted, approval letter is issued.
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• Step 1: Application received undergo initial screening to make
sure the forms are complete and filled in properly.
Forms Required for QU-IRB:
1. Application
2. Checklist
4. Consents / Ascents (if applicable)
5. Supervisor Letter for student graduate projects
6. QU-IBC approval (if applicable)
6. Collaborating Institute’s IRB Approval (if applicable)
7. Any other relevant supporting documents (Dept. Approval)
In case of a renewal request, only a renewal request is needed.
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3. Surveys / Questionnaires
• Please note that for student UG projects, all communication to
IRB should be done by the Supervisor.
• Sample documents can be accessed
throughhttp://www.qu.edu.qa/offices/research/quirb/sample_documen
ts.php
• We recommend to check the IRB website for
querieshttp://www.qu.edu.qa/offices/research/quirb/index.php
• Please send all documents to "[email protected]". Once received, these
documents will undergo an initial screening and thereafter the routine
process for IRB review. The committee may ask further
clarifications/information during the course of the review. Once the
review is complete, IRB decision letter will be issued accordingly.
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• If you are seeking an exemption from the full ethical review
(expedited review), please state that in your email with a
justification for such request.
What Qualifies as Research
Involving Human Subjects?
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Systematic Review of
Research Proposal
Is the project considered
research?
Does the study involve
Human Subjects?
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First Questions to Ask:
Human Subject Research
OR
Data through
intervention or
interaction
Identifiable
private
information
Non-human subjects Exempt research
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A research Involving living individuals
about whom the researcher obtains:
Types of IRB Review
• Review by IRB chair or his/her designee
• Full Board Review
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• Is it considered research?
• Does not involve human subjects?
• Can be exempt from Review?
Exempt Research
The decision may
be made ONLY
by the chair or
designee
The decision
must be done
in advance of
the research
There must be clear determinants of
what qualifies for exempt research
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Research is exempt from full board
review and future review by the IRB
• Not involving vulnerable subjects
• Prisoners
• Children
• Pregnant women
• Not more than minimal risk
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Limitations for Exempt Research
Categories of Exemption #1
• Research on the effectiveness of or the comparison
among instructional techniques, curricula, or classroom
management methods.
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• Research conducted in commonly accepted educational
settings, involving normal educational practices, such as:
• Research on special education instructional strategies,
(Lectures ,Seminars, etc..).
Categories of Exemption #2
• Research involving the use of Survey Procedures, Interview
procedures or Observation of public behavior
• information is obtained and recorded by the investigator
in such a way that the subject can be identified, AND
• disclosure could reasonably place the subject at risk of
criminal or civil liability or be damaging to the subject’s
financial standing, employability, or reputation.
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UNLESS
• Research involving the collection or study of existing
data, documents, records, pathological specimens, or
diagnostic specimens
• If these sources are publicly available OR
• The information is recorded in a way that the subject can not
be identified directly Or through identifiers linked to the
subject
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Categories of Exemption #3
Decision Chart for Review
Research
Activity ?
Yes
No
Yes
Involves
Human
Subject ?
Qualify for
Exempt
Status?
Yes
No
IRB Review
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No need
for IRB
review
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Thank You