Howard University IRB Policies and Procedures Alfonso Campbell, Jr. Donalia Clay Howard University

Events that Prompted Establishment of Institutional Review Board National Research Act (Public Law 93-348) was enacted by Congress in 1974 Two mandates 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. Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report") were published in 1979 Infamous Tuskegee Study, Milgram’s deception study and human experiments with persons imprisoned at concentration camps. IRB is not impediment to research board.

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 Under Federal regulations, any institution engaged in federally-supported 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.

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. Re-certification will be required every two (2) years. Collaborative IRB training initiative.

IRB Sponsored Workshops and Lectures 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. 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.

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.

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

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.

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. Consent forms should be written at a level appropriate to the understanding of the participants to be enrolled; technical language should be avoided. 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).

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