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  • 1.   Aitza M. Haddad, J.D., LL.M.
  • 2.  The Tuskegee Syphilis Study on rural African American males o 1932-1972 • Cited as "arguably the most infamous biomedical research study in U.S. history,“  National Research Act (Public Law 93-348) o Enacted by Congress in 1974  Two mandates: 1. 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
  • 3.  The Federal Policy for the Protection of Human Subjects (Common Rule) covers research supported by most of the existent federal agencies, such as, but not limited to, the Departments of Agriculture (DOA), Justice (DOJ), Defense (DOD), Education (DOE), Veterans Affairs (VA), Transportation (DOT), the Social Security Administration (SSA), the Central Intelligence Agency (CIA), and the Consumer Product Safety Commission (CPSC), and the Department of Health and Human Services (DHHS). o The provisions of the Common Rule are identical to the DHHS Regulations (45 CFR 46, Subpart A).  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). o 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.
  • 4.  Respect for Persons o Respect individual autonomy to deliberate about personal goals and acting on the basis of these deliberations; o Affirms that persons have the right to choose what shall happen to them; o 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 o Maximize benefits for science, humanity, and research participants; avoid or minimize risk or harm.  Justice o Equitable distribution of research burdens and benefits among persons and groups.
  • 5.  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.  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. o For human participants, research supported by the Department of Health and Human Services (DHHS), the OHRP must approve the institution's Assurance before the funds can be awarded. o 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.
  • 6. 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. o 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. o The Assurance applies to all activities initiated by faculty or students (including thesis research).
  • 7.  The Office of Regulatory Research Compliance (ORRC) at Howard University facilitates the work of researchers through the management and support of five University review and compliance committees.  The ORRC is a partner with the Howard University research community in the shared responsibility to ensure that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and staff involved with research.  The ORRC provides support to two Institutional Review Boards (IRB) by maintaining their policies, guidelines, and procedures involving research with human participants: • The Medical IRB and the Non-medical IRB.
  • 8.  The ORRC also has the responsibility to protect the integrity of research conducted at Howard University through its support of the Research Misconduct Committee; supporting investigations and corrective actions related to non-compliance and misconduct.  The ORRC also supports the responsible conduct of research by offering education and training in collaboration with the Graduate School and to faculty, staff, students, and the community at large. Please contact them at (202) 865-8597 or theorrc@howard.edu. o Research Protections Policies, Guidelines and Compliance Information
  • 9.  The ORRC facilitates the activities of the Institutional Animal Care and Use Committee (IACUC) by facilitating research committee reviews and approvals of regulated experiments and teaching activities conducted at Howard University that involve invertebrate animals.  ORRC staff serves Howard University faculty, staff, and students by helping them ensure their research and teaching modules comply with all applicable federal, state, and local regulations and policies, as well as Howard University policies. ORRC staff is available to answer individual inquiries, meet with researchers and instructors, and to present and facilitate educational workshops and trainings.  IMPORTANT LINKS: o HU VETERINARY SERVICES o USDA ANIMAL WELFARE INFORMATION CENTER o ASSOCIATION FOR LABORATORY ANIMAL SCIENCE (AALAS) o ASSOCIATION FOR THE ASSESSMENT & ACCREDITATION OF LABORATORY ANIMAL CARE INTERNATIONAL (AAALAC) o INSTITUTE FOR LABORATORY ANIMAL RESEARCH (ILAR)
  • 10.  The Howard University Institutional Biosafety Committee (IBC) reviews all institutional research activities involving the use of biohazardous agents, recombinant DNA (rDNA) molecules, cell lines, and human tissue including stem cells, viruses, vectors, and any agent that requires approval for biosafety activities as described in current governmental regulatory requirements. Howard University IBC approval is required before research can begin involving any of the previously mentioned substances.  The IBC ensures that all persons, procedures, and facilities engaged in these activities meet the highest standards of laboratory safety and research efficacy in the interest of protecting the environment and the public.  The ORRC staff is available to assist committee members, faculty, staff, and students. Please call (202) 865-8597 or email ORRC (send to: theorrc@howard.edu) for more information.
  • 11.  Howard University IRBs review and provide oversight for all research involving human participants at Howard University and operate in compliance with the regulations of the U.S. Department of Health and Human Services Office of Human Research Protections for the protection of human research participants, including 45 CFR 46, 21 CFR 50, and 21 CFR 56, which govern human participant research as amended to include the Common Rule (FR 56, No. 117,28002). o The Medical IRB Committee is generally charged with reviewing research applications that originate in the Health Sciences division along with research protocols that involve medical procedures, devices, and drugs. o The Non-Medical Committee typically reviews those research applications that originate from the Academic Affairs division along with research protocols that are generally socio-behavioral in scope.
  • 12.  The IRBs are thereby authorized to inspect any Howard University research facility and to obtain records of and observe the consent process for any research study, suspend or terminate research, or take any action it deems necessary to ensure compliance with federal and University policies and regulations.  All research records and staff are accountable to external review and monitoring by funding agencies. o http://www.orrchoward.com/hrabouttheirb.html
  • 13.  Each Committee is comprised of faculty members from across the various disciplines at the University.  Each Committee also have at least two members who are not affiliated with Howard University.  The ORRC currently support 5 Regulatory Research Committees:
  • 14.  Any person who is affiliated with Howard University and who wishes to conduct research involving human participants.  Students, including those who are conducting research for partial fulfillment of degree requirements, must have a member of the faculty serve as their principal investigator. o The principal investigator will play a supervisory role in the research process of the student and will have responsibility for assuring the protection of human participants involved in the study.  Online submission is available and allows you to submit your protocol for review via electronic delivery. You can also chose to bring a hard copy of your protocol into the ORRC. o http://www.orrchoward.com/submit3.html
  • 15. 
  • 16.  “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” See the Common Rule at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr 46.html#46.102. o Further Guidance on what categories of research would meet minimal risk definition can be found at http://www.hhs.gov/ohrp/policy/expedited98.html.
  • 17.  Most of the psychosocio-behavioral qualifies as a minimal risk study. o Studies that pose minimal risk to human participants can often be processed through the "expedite review" pathway. A designated member of the Board can review submissions for approval in those cases. The expedited review process takes from two to three weeks (2- 3 weeks). This process should not be viewed as "hurried" review. Expedited reviews get the same attention as any protocol submitted to the full Board. o Minimal risk studies that involve vulnerable populations (children, pregnant women, fetuses and neonates, human in vitro fertilization, prisoners, economically or educationally disadvantaged participants, cognitively impaired persons) must go before the full Board for consideration.
  • 18.  Studies that do not qualify as "minimal risk" nor for expedited review under the federal regulations are usually considered greater than minimal risk. Greater than minimal risk studies usually involve medical procedures or devices or the review of medical information or charts, or that create some high degree of discomfort for participants. This discomfort can be physical, emotional, social, or psychological. Greater than minimal risk studies not involving medical data should complete one of the following forms: o A1 Form: For Greater Than Minimal Risk Studies o A2 Form: Continuation/Renewal Form For Greater Than Minimal Risk Studies  Greater than minimal risk studies usually involve medical procedures or devices or the review of medical information or charts should also complete the compliance training modules conduct by the Compliance Office in the Howard University Hospital. Studies in this category should complete one of the following forms:
  • 19. o B1 Form: For Greater Than Minimal Risk Studies o B2 Form: Continuation/Renewal Form For Greater Than Minimal Risk Studies o Cancer Registry Forms • All researchers who wish to access data from the Rosemary Williams Cancer Registry (HU Cancer Center Registry) must first complete the Pre- Screening Interview Form in conjunction with the Manager of the Register. The approved data request form is submitted to the IRB along with the appropriate level data application. For more information on the cancer center registry, please click the link to the Rosemary Williams Cancer Registry. o The major of studies will require HIPAA authorization to review protected health and medical information.
  • 20.  http://www.orrchoward.com/IRBForms-Tools.html
  • 21.  INSTRUCTIONS AND GUIDANCE o Ethical Guidelines and Principles o Guidance for Faculty/Research Staff on How to Submit o Guidance for Students on How to Submit o IRB Catergories of Review (Expedited, Exempt, Full Board, etc.) o Checklists for Form Submission  CONSENT DOCUMENTS o HU-IRB Instruction for Preparing Consent Documents  CONFLICT OF INTEREST DISCLOSURE STATEMENT o Conflict of Interest Disclosure Statement  PRINCIPAL INVESTIGATOR ASSURANCE FORM o Principal Investigator Assusrance Form  FORMS FOR GREATER THAN MINIMAL RISK STUDIES o Form A1: For Studies with Greater than Minimal Risk o Form A2: Renewal/Continuation for A1 Studies
  • 22.  FORMS FOR CHART REVIEWS/MEDICAL DATA o Form B1: HIPAA/Chart Review Form o Form B2: Renewal/Continuation for HIPAA/Chart Reviews o Cancer Registry Data Request Pre-Interview Form o Cancer Registry Data Request Applications o Cancer Registry Available Data Fields  FORMS FOR MINIMAL RISK STUDIES o Form C1: For Studies with Minimal Risk Studies o Form C2: Renewal/Continuation of C1 Studies  EXEMPT STUDIES/NON-HUMAN PARTICIPANTS/DATA o Form D1: Request for Exemption (Non-Research/Not Involving Humans)  IRB INFORMATION o HU-HPS Development o Standard Operating Procedures
  • 23. 
  • 24.  HHS regulations define research at 45 CFR 46.102(d) as follows: o Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
  • 25.  HHS regulations define human subject at 45 CFR 46.102(f) as follows: o Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information. • Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. • Interaction includes communication or interpersonal contact between investigator and subject. • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). • Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects (bolding added for emphasis).
  • 26.  FULL BOARD REVIEW o Research that does not meet the criteria for exempt of expedited review must be submitted to the IRB for a review at a convened meeting at which a quorum of the members are present. • Medical IRB meets twice a month and the Non-Medical IRB meets at least once a month. o Research involving "greater than minimal risk" must go before the Full Board review process. • There are four possible outcomes of full board review: (1) approval; (2) minor revisions/additional information required (approval with administrative review); (3) major revisions/additional information required (tabled); and (4) disapproval. Please allow 4 - 6 weeks for full board review.  EXPEDITED REVIEW o Expedited Review is a category related to research that is defined as "minimal risk." Expedited review does not mean "rush" or "speedy" review. o Expedited reviewers must determine the following: Do the research activities meet the definition of "minimal risk" and do they fit within the federally mandated expedited categories? "Minimal risk" is defined as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests." • The outcome of the review may include any of the following: (1) approval; (2) request for additional information; (3) request for changes; (4) request that the review be conducted by the Full Board (which would add additional time to the review process).
  • 27.  There are six criteria for exemption. Only the IRB can make the official determination that your project is exempt based upon 45 CRF 46. 101: 1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such i. research on regular and special education instructional strategies, or ii. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless: i. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to subjects; and ii. any disclosure of the responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, observation of public behavior that is not exempt under paragraph b2 of this section, if: i. the human subjects are elected or appointed public officials or candidates for public office; or ii. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  • 28. 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: i. public benefit or service programs; ii. procedures for obtaining benefits or services under those programs; iii. possible changes in or alternatives to those programs or procedures; or iv. possible changes in methods or levels of payment for benefits or services under those programs. 6. Taste and food quality evaluation and consumer acceptance studies, i. if wholesome foods without additives are consumed or ii. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved y the Environmental Protection Agency or the Food and Safety and Inspection Service of the U.S. Department of Agriculture.
  • 29.  Certain low-risk research is exempt from the requirements of the Federal regulations. o 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.  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.  The ORRC can provide an official letter of determination that your research does not qualify as human subjects research upon request.
  • 30. 
  • 31.  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.
  • 32.  The Federal Regulations detail 8 specific elements of information, which must be provided to each human subject participant: o Description of the research and subject's participation, including the identification of experimental procedures; o Description of reasonably foreseeable risks; o Description of expected benefits; o Potentially advantageous alternatives to participation; o Explanation of confidentiality protections; o Explanation of compensation for injuries policy; o Whom to contact with questions about the research and research participant's rights; o Explanation that participation is voluntary.
  • 33.  Informed consent is not a single event or just a form to be signed. o Rather it is an educational process that takes place between the investigator and the prospective participants.  The basic concepts of the consent process include: o full disclosure of the nature of the research and the participant's participation, o adequate comprehension on the part of the potential participants, and o the participant's voluntary choice to participate  The information that is given to the prospective participant, or his/her representative, must be in language understandable to the participant or representative. o Consent forms should be written at a level appropriate to the understanding of the participants to be enrolled. • Technical language should be avoided. o The use of “first person” is strongly discouraged in consent documents (e.g., "I have been fully informed about") because such statements unfairly ask participants to make statements that the participant s are not in a position to verify (e.g., the participant has no way to verify that the investigator has provided full and complete information).
  • 34. 
  • 35.  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. o 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. o There are fourteen (14) modules, and each module is followed by a quiz. 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. o The cumulative score of all of them will be automatically tallied to give a final score for the course. However, a score of 70% is required for certification of completion of this educational requirement to be granted by the IRB.  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. o Re-certification will be required every two (2) years.
  • 36.  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.
  • 37. 
  • 38.  Maintaining continuous IRB approval for a study is the responsibility of the Principal Investigator and the study team. It is important to note that if you allow your study’s IRB approval to lapse, you, the IRB, and Howard University as an institution are considered to be out of compliance with federal regulations.  WHAT IS THE EXPIRATION DATE? o The date noted in your approval notification – the date stamped on your consent documents by the ORRC. THE EXPIRATION DATE REPRESENTS THE FIRST DATE THAT YOUR STUDY IS NO LONGER APPROVED.  WHAT HAPPENS WHEN MY STUDY EXPIRES? o At the time of expiration of IRB approval, all study activities, including recruitment, consent, data collection, and data analysis, MUST STOP. If certain activities must be continued to ensure the safety of the participants, YOU MUST CONTACT THE ORRC TO REQUEST PERMISSION TO CONTINUE THOSE ACTIVITIES UNTIL IRB APPROVAL IS REINSTATED. YOU CANNOT PROCEED UNTIL YOU HAVE A WRITTEN APPROVAL TO DO SO.  HOW TO ENSURE THAT YOUR STUDY’S IRB APPROVAL IS MAINTAINED: o 1.60 to 45 calendar days prior to expiration date: SUBMIT YOUR RENEWAL APPLICATION TO THE ORRC o 2.30 calendar days prior to expiration date: CONTACT THE ORRC IMMEDIATELY. IT MIGHT BE TOO LATE FOR YOU • TO SUBMIT A CONTINUATION REQUEST. YOU MIGHT HAVE TO SUBMIT A DEVIATION/VIOLATION REPORT. • YOU MIGHT HAVE TO SUBMIT A NEW APPLICATION FOR APPROVAL.
  • 39.  To achieve the overarching goal of ensuring Howard University’s compliance with all federal and regulatory requirements relating to its research enterprise, the Howard University IRB requires people to: o Report expeditiously any proposed changes in previously approved human participant research activities as these changes cannot be initiated without Howard University IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants. o Report immediately any injuries or other unanticipated problems involving risks to participants and others, including research staff. o Report progress of approved research, as often as and in the manner prescribed by the Howard University IRB on the basis of projected risks to participants, but no less than once per year. o Identify and chronicle any modification(s) or clarification(s) in a detailed letter to the chair of the HU-IRB, which becomes an addendum to the original application.  TO HELP YOU MAINTAIN CONTINUOUS IRB APPROVAL: o ORRC staff will send a Notice of Expiration of Approval to the principal investigator beginning in November 2012. This notice will be sent approximately 90, 60, and 30 days prior to the expiration of the approval. Renewal requests must be submitted to the ORRC 90 days before the approval expiration date. Once approval has expired, the project will be inactivated. Once a project's approval has expired, a new application MUST be completed for review and approval before research can resume. It is very important for investigators to follow their approved protocols. If a protocol is not followed as approved, the IRB may suspend those activities.
  • 40.  http://www.orrchoward.com/2013MeetingsandSchedules.html
  • 41.  2013 IRB Meeting Schedule and Submission Deadlines*  2013 IBC Meeting Schedule and Submission Deadlines  2013 IACUC Meeting Schedule and Submission Deadlines  ​2012 Meeting Schedule Archives
  • 42.  