Institutional Review Board (IRB) and Clinical Research
Shu B. Chan, MD, MS, FACEPResearch Director, Emergency Medicine Residency
Program,Member, IRB
Resurrection Medical Center
Agenda
History of the development of the IRBComposition of the IRBOperation of the IRBDuties of the IRBIRB and the EM ResidentTypes of IRB ApprovalsHelpful Tips Regarding IRB
Submissions
Nuremberg Code-1949
Along with the trials of war criminals before the Nuremberg Military Tribunals were a series of directives regarding human experimentation Voluntary consent of the human subject
is absolutely essential Experiments should be necessary for the
good of society and likely to yield results
Nuremberg Code
Experiment designed, based, and justified on prior knowledge
Avoid all unnecessary physical and mental suffering and injury
No a priori reason to believe that death or disability will occur
Risk should not exceed the benefits Proper preparation to protect the
subjects from possibilities of harm
Nuremberg Code
Experiments done by qualified persons Right of the subject to terminate the
experiment Duty of the scientist in charge to
terminate an experiment if continuation is likely to result in injury, disability, or death
Declaration of Helsinki-1964
The World Medical Association adopted a set of ethical principles for medical research involving human subjects
These principles included all the directives from Nuremberg and expanded on them Medical research involving human
subjects includes research on identifiable human material or identifiable data
Declaration of Helsinki-1964
When providing care, the physician shall act only in the patient’s interest
Some research populations are vulnerable and require special protection
Clear formation of an experimental protocol An “ethical review” committee, independent
of the researcher should review all protocols Confidentiality and privacy of the subject
must be respected
The Belmont Report-1979
Report of the meeting of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research at the Belmont Conference Center at the Smithsonian
By this time IRB have been established in most institutions and having difficulties implementing all the rules and directives from Nuremberg and Helsinki
The Belmont Report-1979
It was felt that to better guide the researchers and IRB reviewers, especially in more complex situations, boarder general ethical principles were needed
The concept was that these boarder principles would provide the basis for interpretation of the specific rules and guidelines
The Three Basic Ethical Principles from the Belmont Report
Principle One: Respect of Persons (a.k.a. Autonomy) The principle of “respect for persons” is
divided into two moral requirementsFirst is to acknowledge that to respect a
person’s autonomy requires that the person enters into the research on a voluntary basis and has adequate information to make such a decision
Second is to recognize that certain individuals may have decreased capacity for self-determination and so require special protection
The Three Basic Ethical Principles from the Belmont Report
Principle Two: Beneficence The principle of “beneficence” can be
summarized by two general rules“Do no harm” - the old Hippocratic maximHowever, many times this dictum does not
lend itself to clear cut interpretations and so the second general rule is more applicable
“Maximize possible benefits and minimize possible harms”
The Three Basic Ethical Principles from the Belmont Report
Principle Three: Justice The principle of “justice” can be understood
by considering these important questionsWho should receive the benefits of the research?Who will receive the benefits of the research?Who will bear the burdens of the research?
There needs to be fairness in distribution of persons involved with the answers to those questions
Composition of the IRB
Since much clinical research is funded or under the perusal of the federal government, the Department of Health and Human Services ( Office for Protection from Research Risks) has set specific rules regarding the composition and duties of individual local IRB
Composition of the IRB
Minimum of five membersDiversity of race, gender, and
cultural backgroundDiversity of experience and expertiseProfessional competence necessary
to review researchMembers may not review their own
projects
Operations of the IRB
Have written procedures and follow themMajority of members must be present to
convene a meetingApproval of a research project requires
the approval of a majority of those members present at the meeting
Officials of the institution may not approve research that has not been IRB approved
Duties of the IRB
Review and have authority to approve, require modifications, or disapprove all research activities involving humans
Review and approve informed consent from the research subjects
Continuing review of approved research not less than once per year
Duties of the IRB
Review and approval in accordance with the three Belmont principles of 1: Autonomy (Respect of Person) 2: Beneficence 3: Justice
Prepare and maintain adequate records and documentation of IRB activities
Duties of the IRB
In addition, the IRB must follow more specific rules when reviewing research involving Pregnant women Fetuses Children Prisoners
IRB and the EM Resident
Almost all research done by an EM resident will involve humans in some fashion The humans need not be “experimental
subjects” for the research to fall under IRB perusal
Recall that the Helsinki directives expanded research protection to all identifiable human data
IRB and the EM Resident
The IRB process may be time consuming and residents have specific time tables
Protocol modifications requested by an IRB may make a project not doable
The IRB has the authority to halt a project at any point
Types of IRB Approvals
Expedited review and approval The chairperson may individually review
and approve a proposal or designate an IRB member(s) to review and approve a proposal
There are strict guidelines on when an expedited review is allowed
However a proposal can only be disapproved by the full IRB
Types of IRB Approvals
Exemption from further review This is not an exemption from review All research involving human must have
some sort of initial review and approval The exemption is so that future review
by the IRB is not needed, thus not having to submit follow up reports
Types of IRB Approvals
Waiver of written informed consent Key to the first Belmont principle of autonomy
is the requirement that all human subjects give informed consent to the study
The IRB may give a waiver so that this informed consent need not be in written form
If a written consent form is not included in an application, then that application is incomplete unless a waiver has not requested
Tips for IRB Submission
Because IRB operate under very specific rules and guidelines from the federal government, record keeping tend to be very strict Make sure the application is complete Leave no blanks, write not-applicable if so Be sure consent templates and other
attachments are in order and included
Tips for IRB Submission
All submitted applications should be signed All investigators in the study should be
listed Be sure to submit the necessary number of
copies Don’t forget to include any funding source,
even when the amount is minuscule or the funding is not cash
Have a clear and concise cover letter
Tips for IRB Submission
Many studies by residents are retrospective and involve no or minimal risk to the subjects and so qualifies for expedited review
If the study involves no or minimal risk, then very often further IRB oversight is unnecessary and the study can be exempt
Tips for IRB Submission
If the study qualifies for expedited or exempt status, so state that in the application or cover letter and specifically ask for expedited and/or exempt status
Be sure to list the reasons for the request for expedited and/or exempt status Minimal risks Retrospective study design, etc.
Tips for IRB Submission
If a waiver of written informed consent is requested Be sure that the section of the application
where the written consent is placed has a notation that a waiver is requested
Regardless of whether a waiver is requested or not, the process of obtaining informed consent still must be clearly spelled out
Tips for IRB Submission
Loss of subject confidentiality is an important aspect embodied in the first Belmont principle of autonomy
This issue has become a hot one since the passage of HIPAA regulations
Be very detailed when describing how subject confidentiality is maintained
Tips for IRB Submission
The IRB is charged with protecting the economic rights of the subjects also under the Belmont principle of justice
Any possible increased expense to the subjects must be clearly explained and justified
Provisions for meeting these expenses must be stated
Tips for IRB Submission
If using an established template for IRB application, be sure to review the documents completely so that the application is specific to your project
When in doubt, give more not less information
Have the application reviewed by an experienced mentor
Top Related