Organization of IRBs and SOPs.pptx

DILLA UNIVERSITY
COLLEGE OF HEALTH SCIENCE AND MEDICINE
Seminar on Organization of IRBs and SOPs
Prepared by: - Melkam Andargie

Organization of IRBs and SOPs
• The National Research Ethics Review Committee (NRERC) is
one of the committees established by the Ministry.
• Since the first national guideline for research ethics was
issued in 1995, the NRERC has revised four times in order
to keep up with the dynamic nature of research ethics.
• The National Research Ethics Review Committee (NRERC) is
one of the committees established by the Ministry.
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• Since the first national guideline for research ethics was
issued in 1995, the NRERC has revised four times in order
to keep up with the dynamic nature of research ethics.
• This standard operating procedure is designed to describe how
the Secretariat of the Institutional Review Board (IRB)
manages protocol submissions to the EPHI-IRB.
Organization of IRBs and SOPs Cont…
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Commitment of the government towards research and
research ethics has been expressed in various undertakings;-
 Endorsement of a constitution and legal codes that protect
the well-being, welfare, and autonomy of its citizens,
protecting the right to intellectual and academic freedom,
and the pursuit of knowledge.
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Undertakings cont…
 Establishment of medical and public health colleges since 1952, the
Central Research Laboratory in 1942 which later was upgraded to an
institute, the Institute of Pathobiology in 1966, the Armauer Hansen
Research Institute in 1969, the Demographic Training and Research Center
in 1982, and recently, the National Science Academy.
 Introduction ERC at the university level in the 1970s to protect the rights,
safety, and welfare of research participants and to ensure independent
review of protocols before commencement of research activities.
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• An institutional review board (IRB or IEC or ERB or REB), is
a committee that applies research ethics by reviewing the
methods proposed for research to ensure that they are ethical.
• Such boards are formally designated to approve (or reject),
monitor, and review biomedical and behavioral research
involving humans.
Institutional Review Board (IRB)
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• They conduct some form of risk-benefit analysis
• To assure that appropriate steps are taken to protect the rights
and welfare of humans participating as subjects in a research
study.
• Along with developed countries, many developing countries
have established national, regional or local IRB in order to
safeguard ethical conduct of research concerning both national
and international norms, regulations and codes.
Institutional Review Board (IRB) Cont…
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• A key goal of IRBs is to protect human subjects from physical or
psychological harm
• The protocol review assesses the ethics of the research and its
methods, promotes fully informed and voluntary participation.
• Its composition varies, it includes a balance of academia and non-
academia members. This serves to provide a greater scope of
understanding which helps ensure ethics in research.
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• IRBs are most commonly used for studies in the fields of
health and the social sciences, including anthropology,
sociology, and psychology.
• Such studies may be clinical trials of new drugs or devices,
studies of personal or social behavior, opinions or attitudes, or
studies of how health care is delivered and might be improved.
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• Formal review procedures for institutional human subject studies
were originally developed in direct response to research abuses in
the 20th century.
• Among the most notorious of these abuses were the experiments of
Nazi physicians, a focus of the post-World War II Doctors' Trial, the
Tuskegee Syphilis Study,
• IT was a long-term project conducted between 1932 and 1972 by
the U.S. Public Health Service, and numerous human radiation
experiments conducted during the Cold War.
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• The result of these abuses was the National Research Act of 1974 and the
development of the Belmont Report, which outlined the primary ethical
principles in human subjects review;
• These include "respect for persons", "beneficence", and "justice".
• A bona fide process for obtaining informed consent from participants is
also generally needed.
• However, this requirement may be waived in certain circumstances – for
example, when the risk of harm to participants is clearly minimal.
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• In the United States, IRBs regulations define the rules and responsibilities
for institutional review, which is required for all research that receives
support, directly or indirectly, from the United States federal government.
• IRBs are themselves regulated by the Office for Human Research
Protections (OHRP) within the Department of Health and Human Services
(HHS).
• Additional requirements apply to IRBs that oversee clinical trials of drugs
involved in new drug applications.
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In the United States, IRBs regulations cont…
• FDA and the OHRP have empowered IRBs to approve, require
modifications in planned research prior to approval, or
disapprove research.
• IRBs are responsible for research conducted on human
subjects that are "scientific", "ethical", and "regulatory".
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• In addition to registering its IRB with the OHRP, an institution is also
required to obtain and maintain a Federal wide Assurance (FWA), before
undertaking federally funded human research.
• This is an agreement in which the institution commits to abiding by the
regulations governing human research.
• A secondary supplement to the FWA is required when institutions are
undertaking research supported by the U.S. Department of Defense.
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International ethics review committees
• Numerous other countries have equivalent regulations or guidelines governing
human subject studies and the ethics committees that oversee them.
• However, the organizational responsibilities and the scope of the oversight purview
can differ substantially from one nation to another,
• Especially in the domain of non-medical research.
• The United States Department of Health and Human Services maintains a
comprehensive compilation of regulations and guidelines in other countries, as well
as related standards from a number of international and regional organizations.
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• The International Conference on Harmonization sets out
guidelines for registration of pharmaceuticals in multiple
countries.
• It defines Good Clinical Practice (GCP), which is an agreed
quality standard that governments can transpose into
regulations for clinical trials involving human subjects.
Pharmaceutical trials and good clinical practice
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Pharmaceutical trials and good clinical practice
Here is a summary of several key regulatory guidelines for oversight of
clinical trials:
• Safeguard the rights, safety, and well-being of all trial subjects.
• Obtain trial protocol(s)/amendment(s), written Informed Consent
Form(s) (ICFs) and consent form.
• Review both the amount and method of payment to subjects to assure
neither presents problems of coercion or undue influence on the trial
subjects.
• Ensure that the proposed trial is reviewed within a reasonable time and
document opinions and decisions.
• Continuing review at least once per year.
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The Source of IRB Authority
• The IRB's source of authority and its credibility within
research and administrative communities is reflected in the
appointment process.
• The IRB should be appointed by an individual who has both
administrative stature and credibility with the institution's
research community.
• Since the IRB may be called upon to make difficult and, for
some, unpopular decisions, its authority must not be
questioned.
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• While part of that authority rests in the stature of individual
IRB members among their peers, and another part flows from
federal regulations, a major part of the board's authority and
autonomy lies in the appointment process.
• Generally speaking, the board should be appointed by the chief
executive officer of the institution upon recommendations
received from his chief administrators responsible for research
The Source of IRB Authority Cont…
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• Advice may be sought from the chairmen of departments involved in
research with human subjects or in ethical issues;
• Recommendations may be solicited from the research committee or faculty
senate.
• The chairman of the IRB should have a direct reporting relationship to the
chief executive officer in order to insure the autonomy of the board.
• In many institutions, the administrator directly responsible for research may
be designated as the first line administrator with whom the IRB chairman
may discuss policy issues and specific problems.
The Source of IRB Authority Cont…
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Standard Operational Procedures (SOPs)
• The Scope of SOP applies to all personnel and members of the
IRB.
• Existence of SOPs clarifies and facilitates the decision
making procedures and processes in ethical re-view.
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• Among other things, SOPs shall address points on how reviews are
conducted, meetings are held and decisions are passed and
communicated.
 Written policies and procedures, specify the membership,
 Committee governance; review procedures,
 Decision-making, communications,
 follow-up, monitoring, documentation and archiving,
 Training, quality assurance, and procedures for coordination with
other RECs.
Standard Operational Procedures (SOPs) Cont…
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List of EPHI-IRB SOPs.
• Writing, Reviewing,
• Distributing and Amending Standard Operating Procedures,
• Preparation of Guidelines,
• Constituting Institutional Review Board,
• Confidentiality / Conflict of Interest Agreements,
• Training Personnel and IRB Members,
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List of EPHI-IRB SOPs cont…
• Selection of Independent Consultants,
• Management of Protocol Submission,
• Use of Study Assessment Form EPHI-IRB,
• Exemption of protocol review,
• Expedited Review, Initial Review of Submitted Protocol,
• Review of New Medical Device Study/Evaluation,
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• Review of Resubmitted Protocol,
• Review of Protocol Amendments,
• Management of Protocol Continuing Reviews,
• Review of Final Reports, Intervention in Protocol
Deviation/Noncompliance/Violation,
• Response to Research Participants’,
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• Management of Study Termination,
• Review of Serious Adverse Event (SAE),
• Site Monitoring Visits,
• Agenda Preparation,
• Meeting and Minutes Taking Procedures, Emergency Meeting,
• Communication Records,
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• Maintenance of Active Study Files,
• Archive and Retrieval of Documents,
• Maintaining Confidentiality of IRB’s Documents,
• Auditing, and Inspection and
• Glossary of Terms and Definitions.
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References
1. The Office of Human Research Protection. Institutional Review Board Guidebook.
"Chapter 3, Section A: Risk/Benefit Analysis.” pp. 1-10 [1] Retrieved May 30, 2012
2. Mohamadi, Amin; Asghari, Fariba; Rashidian, Arash (2014). "Continuing review of
ethics in clinical trials: a surveillance study in Iran". Journal of Medical Ethics and
History of Medicine. 7: 22. PMC 46482 12. PMID 26587202.
3. "Code of Federal Regulations". HHS.gov. 2010-01-15. Retrieved 2014-03-28.
4. "IRBs and Assurances". hhs.gov. 22 December 2010.
5. Human Research Protection Program (HRPP). Archived 2014-09-16 at the Wayback
Machine
6. HRPP Information Sheet for DoD Addendum. Archived 2014-09-16 at the Wayback
Machine
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