Transcript Howard University IRB Policies and Procedures

Howard University IRB
Policies and Procedures
Alfonso Campbell, Jr.
Donalia Clay
Howard University
Events that Prompted Establishment of Institutional Review Board
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National Research Act (Public Law 93-348) was enacted by Congress in 1974
Two mandates
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1. This Act prompted the establishment of IRBs at the local level and required IRB
review and approval of all federally funded research involving human participants.
The Institutional Review Board (IRB)- is a committee established to protect the rights and
welfare of human research participants recruited to participate in research activities conducted
under the auspices of the institution with which it is affiliated. The IRB reviews and has the
authority to approve, require modifications in, or disapprove all research activities, including
proposed changes in previously approved human participant research.
2. The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research be established.
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Ethical Principles and Guidelines for the Protection of Human Subjects of Research
(the "Belmont Report") were published in 1979
Respect for Persons
 Respect individual autonomy to deliberate about personal goals and
acting on the basis of these deliberations;
 Affirms that persons have the right to choose what shall happen to
them;
 Protect individuals with reduced (prisoners, mentally challenged,
emotional disorders, impaired brain functions, immature {minors},
comatose, terminal illnesses) autonomy; these persons entitled to
have a legally authorized representative act in their behalf.
Beneficence
 Maximize benefits for science, humanity, and research participants;
avoid or minimize risk or harm.
Justice
 Equitable distribution of research burdens and benefits among
persons and groups.
General Assurance for the Protection of Human
Participants
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Under Federal regulations, any institution engaged in federallysupported human participant research is required to provide written
Assurances of Compliance, describing the means they will employ to
comply with HHS regulations regarding the protection of human
participants in research.
For human participants research supported by the Department of
Health and Human Services (DHHS), the Office for Human Research
Protections (OHRP) must approve the institution's Assurance before
the funds can be awarded
The University's assurance identifies its responsibilities and explains
the steps that will be taken to meet the federal regulations for
research on human subjects.
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Although protection of research participants is a concern of all
federal agencies that sponsor research, leadership is vested in the
Office for Human Research Protection (OHRP) and the Food and
Drug Administration (FDA). The OHRP has general responsibility for
the protection of humans as participants in research, and the FDA
regulates the use of drugs and medical devices in experiments.
Howard has developed a General Assurance as a part of the
continuing effort to facilitate research, while at the same time
complying with federal regulations regarding the protection of
humans who serve as participants in research activities. These
assurances affirm that all activities related to human participants
research, regardless of funding source, will be guided by the ethical
principles in the Belmont Report. Federal Wide Assurance is an
agreement with OHRP.
The Assurance applies to all activities initiated by faculty or students
(including thesis research).
Roles and responsibilities of HUIRB
 This institution has established continuing programs to
educate IRB members, IRB staff, and research
investigators about human participants protection
requirements.
 The IRB conducts continuing review of approved
research at intervals appropriate to the degree of risk,
but not less than once per year.
 The IRB has the authority to suspend or terminate
previously approved research that is not being
conducted in accordance with the IRB's requirements, or
that has been associated with unexpected serious harm
to participants.
Education and Training
 All individuals seeking funds from any source, including the university, to
support any activity involving human participants in any way, will be
required to complete an online (CITI) course tutorial. The course takes
approximately two (2) to three (3) hours to complete however, it does not
have to be completed in one session and can be completed in any order.
Each module is followed by a quiz and the cumulative score of all of them
will be automatically tallied to give a final score for the course. A score of
70% is required for certification of completion of this educational
requirement to be granted by the IRB.
 Because of the diversity of the population which Howard University and its
Hospital serve and the complexity of its various programs involving or
potentially involving human participants, the IRB requires that all principal
investigators, other key personnel and students complete all fourteen (14)
modules.
 The content of this educational program will be periodically up-dated to
keep it current as changes or modifications in federal or institutional policies
and regulations occur. Module 14 is designed to serve that purpose. Recertification will be required every two (2) years.
IRB Sponsored Workshops and Lectures
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In addition to the online educational program, the IRB anticipates
hosting at least two workshops per year to keep the university's
constituencies apprised of the latest information on the regulations
and policies that relate to the involvement of human participation in
research and other activities.
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The purpose of these workshops include the dissemination of
institution-specific information, review of information pertinent to
the responsible conduct of research (RCR), regulations, invited
intramural and extramural guest lecturers and presentations of case
reports. In contrast to the internet-based course, these workshops
will facilitate face-to-face interactions between individuals at all
levels of the institution.
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Exempt research
Certain low-risk research is exempt from the requirements of the Federal
regulations.
These exemptions do not imply that investigators have no ethical
responsibilities to subjects in such research; they mean only that IRB review
and approval of the research is not required by Federal regulations.
In no case should investigators make the final determination of exemption
from applicable Federal regulations or provisions of their institution's
Assurance.
Belmont Report on exempt research
Research conducted in established or commonly accepted educational
settings, involving normal or educational practices, such as 1)research on
regular and special and special education instructional strategies, or 2)
research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods, Research
involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of
public behavior.
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Informed Consent
Unless specifically authorized by the IRB, no investigator may involve a human being as a
participant in research unless the investigator has obtained the legally effective informed consent
of the participant or the participant's legally authorized representative.
Informed consent is the voluntary choice of an individual to participate in research based on an
accurate understanding of its purposes, procedures, risks, benefits, alternatives, and
any other factors that may affect a person's decision to participate.
Informed consent must be legally effective under applicable state law and must include the eight
specific elements described in the Federal regulations.
Unless specifically waived by the IRB, informed consent must be documented in writing.
The Consent Process
Informed consent is not a single event or just a form to be signed — rather it is an educational
process that takes place between the investigator and the prospective participants.
The basic concepts of the consent process include:
full disclosure of the nature of the research and the participant's participation,
adequate comprehension on the part of the potential participants, and
the participant's voluntary choice to participate
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Elements of Informed Consent
The Federal regulations detail specific elements of information which
must be provided to each subject:
description of the research and subject's participation,
including the identification of experimental procedures;
description of reasonably foreseeable risks;
description of expected benefits;
potentially advantageous alternatives to participation;
explanation of confidentiality protections;
explanation of compensation for injuries policy;
whom to contact with questions about the research and research
participant's rights;
explanation that participation is voluntary.
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Documentation of Consent
The information that is given to the prospective participant, or
his/her representative, must be in language understandable to the
participant or representative.
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Consent forms should be written at a level appropriate to the
understanding of the participants to be enrolled; technical language
should be avoided.
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OHRP strongly discourages use of the "first person" in consent
documents (e.g., "I have been fully informed about"). Such
statements unfairly ask participants to make statements that the
participant is not in a position to verify (e.g., the participant has no
way to verify that the investigator has provided full and complete
information).
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Federal Regulations and Policy
The Federal Policy for the Protection of Human Subjects (Common Rule) covers
research supported by the Departments of Agriculture, Energy, Commerce, HUD,
Justice, Defense, Education, Veterans Affairs, Transportation, and HHS, as well as
NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product
Safety Commission.
The provisions of the Common Rule are identical to the DHHS Regulations (45 CFR
46, Subpart A).
Food and Drug Administration
The Food and Drug Administration (FDA) has a separate set of regulations governing
human participants research (21 CFR 56 – IRBs and 21 CFR 50 – Informed Consent).
The basic requirements for IRBs and for Informed Consent are congruent between
the two sets of regulations.
The Common Rule is based on federal funding of research; FDA regulations are based
primarily on use of FDA regulated products: drugs, medical devices for human use, or
biological products