...States. Learning Objectives By end of the module you should be able to: * Describe the role, authority, and composition of the IRB. * List the IRB requirements for conducting research involving human subjects. * Describe the types of IRB review. * Describe the process of working with the IRB. * Identify other regulations and regulatory groups that require compliance based on the type of research being conducted. IRB Role, Authority, and Composition The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government. Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for this committee. To clarify when IRB review is required, let's define some terms: * Research: Federal regulations define research as: "a systematic investigation... designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)] If an investigator is unclear about whether a planned activity is research, the investigator should contact his/her IRB office. * * Human Subjects: The Department of Health and Human Services (DHHS) regulations define a human subject as "a living...
Words: 5929 - Pages: 24
...AHS 301 Systematic Review Group Assignment Total of 405 points From your assigned topic, you will need to develop a clinical/research question that will allow you to conduct and write a (modified) systematic literature review. The clinical/research question must be approved by the instructor by June 17, 2016. The (modified) systematic literature review must include: 1. An introduction/background section – brief description of the background on the topic focusing specifically on the clinical/research question. Be sure to include enough information so that someone who is not familiar with the topic/research question has a firm understanding of the significance. 2. A methods section – description of search strategy (including databases and keywords) used to identify the relevant peer-reviewed primary studies. Be sure to include a full description of the inclusion/exclusion criteria. You need to provide enough information so that the search can be repeated. 3. A results section – description of the articles selected. Use of tables containing relevant information might be appropriate. 4. A discussion section – integrated synthesis of the results found. Be sure to include any limitations and/or strengths that resulted from the analysis of the primary studies. 5. A conclusion section - application of synthesized results to the appropriate patient population. 6. Use of APA 6th edition guidelines for formatting and references. ...
Words: 286 - Pages: 2
... Director, Institutional Review Board XYZ Medical Centre XYZ Medical Centre at Boston Boston, Ma FROM: John Johnson Investigator, Institutional Review Board (IRB) XYZ Medical Center at Boston Boston SUBJECT: Violations observed during the FDA inspection of XYZ Institutional Review Board from August 21 to August 25 1, 2006 I am writing this letter to set out all the non- compliance issues identified during the FDA inspection of XYZ Institutional Review Board (IRB). These violations are pertaining to applicable provisions of Title 21, Code of Federal Regulations (21 C.F.R.) Part 56 Institutional Review Boards, Part 50-Protection of Human Subjects, and Part 812 Investigational Device. The compliance issues can be summarized as follow: 1- The IRB failed to establish, maintain, and follow adequate written procedures for conducting the review of research. (21 CFR 56.108, 21 CFR 56.110(c), and 21 CFR 56.115{a){6)] 2- The IRB failed to prepare and maintain adequate documentation of IRB activities. {21 CFR 56.115] In regards to inadequate documentation, I would like to point out to some specific issues that have been ignored at the IRB, such as: ...
Words: 531 - Pages: 3
...relevant for researchers in the social and behavioral sciences and the humanities. Methods include surveys, interviews, focus groups, oral history, participant observation, observations of public behavior, and the analysis of existing data. Topics include research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior. In addition to explicitly identifying these methods, the regulations include provisions that allow for appropriate review of social science, humanities, and behavioral research. For example, the regulations: * Identify research activities that are low risk, for example, a survey in which no identifiers are collected, and that are thus exempt from the remaining provisions of the regulations, such as the requirement for continuing review. * Identify research activities with no more than minimal risk that can be reviewed by one or more Institutional Review Board (IRB) members, rather than at a convened IRB meeting. * Allow for waivers of the requirement to obtain written consent, for example, in a study of undocumented workers. * Include provisions that permit researchers to withhold information in the consent process. This provision is important when some degree of deception is required in...
Words: 2798 - Pages: 12
...Basic Institutional Review Board (IRB) Regulations and Review Process Content Authors Ada Sue Selwitz, M.A. The University of Kentucky Norma Epley, M.S. East Carolina University Janelle Erickson, MPH Institute for Systems Biology Introduction The purpose of this module is to provide a basic understanding of the human subject protection regulations that govern the participation of human volunteers in research in the United States. Learning Objectives By end of the module you should be able to: Describe the role, authority, and composition of the IRB. List the IRB requirements for conducting research involving human subjects. Describe the types of IRB review. Describe the process of working with the IRB. Identify other regulations and regulatory groups that require compliance based on the type of research being conducted. IRB Role, Authority, and Composition The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government. Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for this committee. To clarify when IRB review is required, let's define some...
Words: 5985 - Pages: 24
...modules have three corresponding sets of refresher modules and the basic SBE modules have two corresponding sets of refresher modules. These refresher modules are intended to provide learners with a review of what was covered in the basic level modules. It is generally recommended that organizations select refresher module requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle at an interval specified by your organization (for example, Refresher Stage 1: 3 years after completion of basic course; Refresher Stage 2: 6 years after completion of basic course). Three additional standalone courses are available: Institutional/Signatory Official: Human Subject Research, and IRB Chair. The Institutional/Signatory Official: Human Subject Research course provides a general introduction to the roles and responsibilities of the institutional official at an organization holding a Federalwide Assurance (FWA). The IRB Administration course offers members of an Institutional Review Board’s (IRB) administrative office a comprehensive review of the critical areas associated with IRB, human research protection program (HRPP), and HRPP/IRB office operations. The IRB Chair course provides detailed training for current and future IRB chairs. This catalog provides a listing and description of each module within the HSR series, as well as their recommended use, continuing education...
Words: 9766 - Pages: 40
...Tarver ID: 5548861 Log Out Help CITI Program Collaborative Institutional Training Initiative at the University of Miami Search Knowledge Base Search Main Menu My Profiles My CEUs My Reports Support Main Menu › Quiz Basic Institutional Review Board (IRB) Regulations and Review Process Basic Institutional Review Board (IRB) Regulations and Review Process Quiz Instructions: Please provide an answer for all questions. Each question is one point. Click on the Submit button to register your answers. After submitting your answers, the correct answer to each question and an explanation will be displayed. Navigational links to the next module will be provided. All quiz questions count towards your score. You should answer all questions. Question 1 Multiple Choice/Single Answer - Select only one answer A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience to the IRB only if there are several other occurrences. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. Report the adverse drug experience as part of the continuing review report. Do not report the adverse drug experience to the IRB since it is a common adverse experience. Question 2 Multiple...
Words: 492 - Pages: 2
...Health Care The Nevada Institutional Review Board (IRB) is a group that is designated to oversee research that is done that involves human participants. This committee or group is to make sure that the rights and welfare of the human subjects remain intact. According to the University of Nevada, Las Vegas (UNLV), “Each Institutional Review Board (IRB) at UNLV falls under the umbrella of the Federal Wide Assurance (FWA) #00002305, which assures that the university will adhere to federal regulations regarding human subjects’ research. The FWA is approved by the Department of Health and Human Services, Office for Human Research Protection.” The legislature created this board in 2005. However, over the years the committee of this board has become corrupt. The article states that the board was designed to for scientific research, however, the legislature granted the IRB to be run by the Board of Homeopathic Medical Examiners instead of a board that had more regulations over more traditional medicine. According to the article, “The Nevada IRB was crafted to allow the Board of Homeopathic Medical Examiners to review, approve, oversee and control certain research studies which use drugs and other therapies it regulates. In theory, the IRB was created for the very necessary and infinite hope offered by stem-cell research. In reality, it's a massive testing ground where the unending pockets of the pharmaceutical companies can exert power over measly state boards and the lawmakers who create...
Words: 767 - Pages: 4
...Quiz Results - Basic Institutional Review Board (IRB) Regulations and Review Process You correctly answered 3 of 5 and received 3 of 5 possible points. Scroll down to review the quiz questions and the explanation of the answers. Question 1 Question : | A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? | Your answer : | Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. | Correct Answer : | Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. | Comment : | The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution. | Points Earned : | 1 | Question 2 Question : | How long is an investigator required to keep consent documents, IRB correspondence, and research records? | Your answer : | For a minimum of three years after completion of the study | Correct Answer : | For a minimum of three years after completion of the study | Comment : | Research investigators are responsible for retaining signed consent documents, IRB correspondence, and research records for at least three years after...
Words: 277 - Pages: 2
...Quiz Results - Basic Institutional Review Board (IRB) Regulations and Review Process You correctly answered 5 of 5 and received 5 of 5 possible points. Scroll down to review the quiz questions and the explanation of the answers. Question 1 Question : A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Your answer : Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. Correct Answer : Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. Comment : The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution. Points Earned : 1 Question 2 Question : How long is an investigator required to keep consent documents, IRB correspondence, and research records? Your answer : For a minimum of three years after completion of the study Correct Answer : For a minimum of three years after completion of the study Comment : Research investigators are responsible for retaining signed consent documents, IRB correspondence, and research records for at least three years after completion of the research. Since...
Words: 674 - Pages: 3
...The history of conducting research with prisoners has been problematic. As a group, prisoners have been a population of convenience; researchers knew where they were and would be, often for many years. In addition, prisoners lived under controlled conditions conducive to research. It was generally accepted to use prisoners as research subjects for testing medicines, drugs, and medical devices without regard to the risks, benefits, and rights of those individuals. As documented in Acres of Skin: Human Experiments at Holmesburg Prison (Hornblum 1998), prisoners were used in lieu of laboratory animals to test the toxicity of cosmetics. In other experiments, prisoners were irradiated in research conducted by the Atomic Energy Commission, rendering some sterile and others badly burned. These are only two examples of many experiments using prisoners as subjects. In 1978, the United States (U.S.) Department of Health, Education, and Welfare, the predecessor to the U.S. Department of Health and Human Services (HHS), issued additional regulations providing safeguards for prisoners as research subjects: Subpart C: "Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects." These regulations address the fact that prisoners are under constraints that could affect their ability to make truly voluntary and un-coerced decisions to participate in research. Subpart C imposes strict limits on the involvement of prisoners as research subjects. The...
Words: 2488 - Pages: 10
...Internal Review Board For The Protection Of Human Subjects In Research North Carolina Central University INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH Request for Review of Research Involving Human Subjects COVER SHEET | | (For Staff Use Only) | | |1. School/Department/Unit:NCCU/Psychology |REQUEST #____________ |Today's Date February 3, 2005 | 2. Name of Principal Investigator (PI) ______________________________________________ Name of Faculty Advisor (FA), if PI is a student__Dr. Les Brinson _________________________________ Telephone Number (PI): 919*530*4526_ Mailing Address (PI): PO Box 19408 Durham, NC 27707 Telephone Number (FA):919*530*5166 Mailing Address(FA): Taylor Ed. Rm 217A Durham, NC 27707 3. PROJECT TITLE: ____________Organizational Communication and Its Relationship With Job Performance and Job Satisfaction _________ 4. PROJECT TYPE: __N__ (Select one: N = New; AR = Annual Renewal; PC = Protocol Change) This is a : _SP__ (Select one: SP = SPECIFIC PROJECT or GP = GRANT PROJECT PROPOSAL) If Grant Project Proposal, list agency and address to which project is being submitted: __________________________________________________________________________________________ ...
Words: 3623 - Pages: 15
...Questionnaire Introduction Check Your Knowledge Introduction Agenda – Day One • • • • • • • • Research roles and responsibilities Policies and Procedures overview Institutional Review Board Office (IRB) NUCATS NURAP Conflict of Interest (COI) Export Controls Innovation & New Ventures Office (INVO) Introduction Introduction Research Administration Training The need for research administration training exists because of the large dollar amounts in research funding and the importance of compliance: • NU received $511.7 million in research funding in FY 2011 • NU ranked 25th in NIH research funding to universities in 2010 • Ensuring compliance remains a federal priority Source: Office for Research Annual Report. (2011): Northwestern University Introduction Research Administration Training Research Administration training helps Northwestern: • Decrease compliance risks • Administer grants more consistently & efficiently • Provide support for research administrators, faculty & staff • Meet federal government expectations regarding training and communication Introduction Training Objectives During this seminar we will: • Explain the research administration process • Discuss the roles & responsibilities of research faculty and staff • Describe the roles of the central research offices • Review the regulatory fundamentals that form the foundation of research administration Introduction Questions? Introduction Roles & Responsibilities Lauran...
Words: 5758 - Pages: 24
...ETHICS APPROVAL APPLICATION TO IRB (INSTITUTIONAL REVIEW BOARD) Is this the right ethics approval application for your study? NO, if: * you will be collecting data from minors (age 17 and under), or * your own subordinates/students/clients would be asked to provide data specifically for research purposes, or * individuals with a mental or emotional disability will be specifically recruited as participants, or * individuals in crisis (i.e., natural disaster victims) will be specifically recruited as participants, or * participants will be recruited through a residential facility such as a prison or nursing home, or * participants who are less than fluent in English will be specifically recruited as participants, or * individuals aged 65+ will be specifically recruited as participants, or * economically disadvantaged individuals will be specifically recruited as participants, or * military personnel will be specifically recruited as participants YES, if: * your data collection consists only of surveying/interviewing non-vulnerable adults, or * your data was/will be created as part of an organization’s standard operating procedures, or * data collection will be completely anonymous (i.e., without a signature line on consent form and even the researcher won’t know who participated and who didn’t). Even if you meet criteria above, in some situations the Institutional Review Board (IRB) may require you to complete the...
Words: 2791 - Pages: 12
...montana.edu/research/osp/documents/CITICheatSheet.doc o o CITI On-Line Responsible Conduct of Research (RCR) Course. MSU “Research” ...Research Compliance. CITI (RH Column) https://www.citiprogram.org/. [DOC]CITI IRB Mandatory Training “Cheat Sheet” media.news.health.ufl.edu/.../CITI%20IRB%20Training%20Cheat%20Sh... o o CITI IRB Mandatory Training “Cheat Sheet”. Effective January 7th, 2013, IRB-01 required Mandatory Training for researchers. This training has 3 components:. [XLS]Human Subjects Research (HSR) Series - CITI https://www.citiprogram.org/citiDocuments/Forms/Order_Form.xls o o To discuss course recommendations that combine modules from different CITI Programofferings, please contact the CITI Program Help Desk at (305) 243-7970. HSP Training FAQ Answers www.research.uky.edu/ori/human/HSPtrainingFAQanswers.htm o o Jump to CITI User Information - QUESTION, ANSWER. 1. How do I create a CITI user account? CURRENT CITI USERS – Users that have an existing CITI ... [DOC]A FEW ANSWERS TO QUESTIONS YOU MAY ALREADY ... https://science.nichd.nih.gov/.../A%20FEW%20ANSWERS%20TO%20Q... o o Training curricula are specified as Clinical Research, Epidemiological and ... Just-inTime CITI courses may be required by the IRB or PI if an investigator is ... Download Citi Training Quiz Answers PDF - YouTube ▶ 0:16 https://www.youtube.com/watch?v=7zdVau36u8A Jul 28, 2015 - Uploaded by Chung Whipple Download Citi Training Quiz Answers...
Words: 449 - Pages: 2
