33 STG IRB Lecture.pdf

IRB and Research Procedures Sean T. Grambart DPM FACFAS D. ABFAS Assistant Dean of Clinical Affairs DMU-CPMS Objectives https://www.hhs.gov/ohrp/ https://ori.hhs.gov/ https://www.ecfr.gov/ ...

IRB and Research Procedures Sean T. Grambart DPM FACFAS D. ABFAS Assistant Dean of Clinical Affairs DMU-CPMS Objectives https://www.hhs.gov/ohrp/ https://ori.hhs.gov/ https://www.ecfr.gov/  3 Investigator Know the regulations applicable to your research Responsibility Understand and follow the regulatory and institutional requirements and policies to obtain approval to conduct the research Get appropriate training Accept responsibility for compliance from the beginning to the end of the project Human cruelty perpetrated in the name of research Nazi Medical War Crimes – experiments that were unprecedented in their scope and degree of harm and suffering to which human beings were subjected Source: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp 181-182. 9/15/24 5 1972 - First News Articles Condemns the Study Ø The men were never given adequate treatment for the disease Ø Even when penicillin became the drug of choice for syphilis “I don’t know what they used us for. I ain’t never understood the study.” Survivor of Tuskegee Syphilis Study, 1932-72  1974 – First Regulations 1991 Rules for DHHS - Title 45 of the Code Most Federal departments – the Use of of Federal Regulations (CFR), Part 46 (45 CFR 46) – Common Rule (45 CFR 46, Subpart A) Human Protection of Human Subjects FDA – 21 CFR Part 50 – Subpart A – Additional Protections for Pregnant Subjects in Protection of Human Subjects and 21 CFR Part 56 - Women, Fetuses, and Neonates Research Institutional Review Boards Subpart B – Additional Protections for Prisoners Subpart C – Additional Protections for Children 6  Provides leadership in the protection of the Office for rights, welfare, and well-being of human Human subjects Research Offers comprehensive training on human Protections research protection based on the revised Common Rule (or 2018 Requirements) Published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that complies with the HHS regulations Office for Human Research Protections | HHS.gov 7  Is it research Need for IRB Approval - Are human subjects involved Three Questions… Is the research exempt 8  What is an Institutional Review Board (IRB) Institutional Review Board (IRB) Any board, committee, or other group formally designated by an institution Review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects The term has the same meaning as the phrase institutional review committee 9  IRB Membership Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. Each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. 10  Human Research Protections Program Pathway for Changes Required or Changes Made Changes Required/Made Convened IRB Full Board/Expedited Studies Mee1ng/IRB Chair Review PI/Student Dept Chair Inves1gator Signs off to Study Approved Designs Study – Ensure Merits Office of and PI No1fied and Completes of Proposal Exempt Studies Research IRB Applica1on (1) (2) (3) (4) Start Finish 11 Institutional Policies 12  Regulations Related to Research Involving Humans 45 CFR 46 Protection of Human Subjects (DHHS) 21 CFR 50 Protection of Human Subject (FDA) 21 CFR 56 Institutional Review Boards (FDA) 21 CFR 812 Investigational Device Exemptions (FDA) 21 CFR 312 Investigational New Drug Application (FDA) Health Insurance Portability and Accountability Act of 1996 (HIPAA) State law regarding research involving humans, e.g., Iowa Code 600A.2(12) for the definition of a child and a guardian who can sign an informed consent document, Iowa Code Chapter 235B, and Iowa Code 235E for abuse of a dependent adult 13  To figure out whether your project is non- exempt human subject research under the Research Common Rule, as the following three Requiring IRB questions in this order. Review or Non- 1. Is the activity research according to the regulations? exempt Human 2. Does the research involve human Subject subjects based on the definition in the Research regulations? 3. Is the human subjects research exempt? Reminder: The FDA does not have exempt categories of research.  Defining Research Determining if a project meets the federal definition of research involves the following questions. 1. Does the activity involve a systematic investigation? A systematic investigation generally refers to a methodological approach involving a hypothesis, research question, and a plan to collect and analyze data systematically. 2. Is the activity designed to develop or contribute to generalizable knowledge? The systematic investigation adds information and contributes to generalizable knowledge in the field. If or how an investigator shares the results or information with the scientific community is not the deciding factor for whether the activity was designed to contribute to generalizable knowledge. A lot of information is published from activities that don’t meet the definition of research. And sometimes, results from research that meets the definition never get published.  1. Scholarly and journalistic activities that focus on Four information specifically about certain individuals (e.g., oral history, journalism, biography, literary Activities criticism, legal research, and historical scholarship). that Are 2. Certain public health surveillance activities. 3. Collection and analysis of information, biospecimens, or records by or for a criminal Not justice agency for activities authorized by law or court order solely for criminal justice or criminal Research investigative purposes. 4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 9/15/24 Federal Human Subject: “a living individual about whom an investigator (whether professional or Definition student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, of Human and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, Subject analyzes, or generates identifiable private information or identifiable biospecimens.” 17 9/15/24 Defining a Human Subject 18 If for a research study… Then… An investigator: interacts with a living individual, asks them to take part in an intervention, The research likely involves manipulates their environment, or human subjects. collects identifiable materials/information about them. 9/15/24 If… Then… An investigator gathers information Only the babies Identifying about newborns by asking mothers are the human the Subject… questions only about the babies subjects The investigator asks for Only the mothers “A living information only about the mothers are human individual subjects about whom” The investigator asks the mothers what they think about their babies’ Only the mothers are human behavior subjects The investigator asks the mothers Both are human how the babies behave and what subjects the mothers the mothers think about their behavior 19 9/15/24 Interaction and Intervention… (i) Obtains information or biospecimens through intervention or interaction with the individual Interactions occur when investigators communicate or have interpersonal contact with research participants, for example, verbally, in writing, or electronically, to obtain information about them for the research. Interventions, on the other hand, include both physical procedures by which investigators collect information or biospecimens and manipulations of the subjects or the subjects’ environment for the research. Examples of interventions include assigning subjects to take a particular drug in a clinical trial, asking subjects to complete a certain task for research purposes, and changing the background noise level to study how subjects’ stress levels vary. 20 9/15/24 Private and Identifiable An activity can also be human subjects research if investigators have private information about individuals or their identifiable information or specimens for research. For example, collecting health information from patient files. 21 22 9/15/24 23 9/15/24 24 Summary At DMU - All studies require some level of review Review must occur before initiation of the study The IRB, not the investigator, determines the type of review required Exempt Expedited Full Committee Review No changes can be made after IRB review unless the IRB approves them  Questions About the IRB and Your Research 25 Contact: The Office of Research, 271-1372, [email protected]