...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 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:...
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...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: __________________________________________________________________________________________ ...
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...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...
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...SHORT-FORM 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...
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...Additional Modules of Interest should be used in any course variation, if relevant. The basic Biomed 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...
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...38). As such, the participants must be informed of the nature of the research that is to involve them. Additional and important components of ethical considerations of action research are freedom from harm, anonymity, and confidentiality. Typically, the process of obtaining Institutional Review Board (IRB) approval is required for action research as well as other types of research in the field of education for the purpose of protecting human research participants (Brydon-Miller & Greenwood, 2006). However, IRB approval for your action research project conducted in this class only will not be required since the consent form will be used. The process of obtaining permission by the participant and submitting a completed Consent Form is pivotal to the continuation of this research project and in the successful completion of this course. Some students received approval for the Informed Consent process from your EDU671 Instructor. If this is the case, please submit the approved Informed Consent document only. If you have had a change to your organization, research, or parties, you are required to submit a revised Action Research Informed Consent Form or Informed Consent Alternative for your Instructor’s review. Submit Consent Form (4 points): Submit a completed and accurate Informed Consent Form signed by the research participant in your study no later than Day 7. For some of you, you will upload the form approved in EDU671. For others of you who have made a change to your research...
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...topics of inquiry 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...
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...APPENDIX E IRB Approval From: Institution Review Board Sent: Wednesday, May 05, 2010 2:37 PM To: Gouge, William; Mowen, Carol; Garzon, Fernando L. Cc: Institution Review Board Subject: IRB Approval 844.042010: A COMPARISON RESEARCH STUDY ON THE USE OF SCHOOL UNIFORMS AND GRADUATION, ATTENDANCE, AND SUSPENSION RATES IN EAST TENNESSEE Dear William, We are pleased to inform you that your above study has been approved by the Liberty IRB. This approval is extended to you for one year. If data collection proceeds past one year, or if you make changes in the methodology as it pertains to human subjects, you must submit an appropriate update form to the IRB. Attached you’ll find the forms for those cases. Thank you for your cooperation with the IRB, and we wish you well with your research project. We will be glad to send you a written memo from the Liberty IRB, as needed, upon request. Sincerely, Fernando Garzon, Psy.D. IRB Chair, Liberty University Center for Counseling and Family Studies Liberty University 1971 University Boulevard Lynchburg, VA 24502-2269 (434) 592-4054 APPENDIX E IRB Approval From: Institution Review Board Sent: Wednesday, May 05, 2010 2:37 PM To: Gouge, William; Mowen, Carol; Garzon, Fernando L. Cc: Institution Review Board Subject: IRB Approval 844.042010: A COMPARISON RESEARCH STUDY ON THE USE OF SCHOOL UNIFORMS AND GRADUATION, ATTENDANCE, AND SUSPENSION RATES IN EAST TENNESSEE ...
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...When asked if Institutional Review Boards are necessary, or at least beneficial, for research teams to work with, most people will readily say yes. “For ethical standards” is the mantra for this, as indeed, there have been instances in the government research sector itself when projects, funded by federal money, violated the very principles that the nation was founded upon. Most notable of these is the Tuskegee Experiment. When the Washington Evening Star newspaper made public the existence of the Tuskegee Syphilis Study in which dozens of black men were allowed to die without treatment, nearly everyone decried that there should have been an impartial board of people to oversee the experiment and, if necessary, terminate the project. Such is a prime example of how the existence of Institutional Review Boards would have helped ensure that experiments and studies seek to preserve the rights of “life, liberty, and the pursuit of happiness” and not undermine them. That being said, one can likewise understand how the presence of Institutional Review Boards can hinder and delay the research process. There is a pernicious enemy: bureaucratic red tape. Having to go through channels and procedures can hold up research and delay the oft-times crucial publication of results, or sometimes even muzzle it completely, as in the case of one researcher who was barred from using her own research despite it being privately funded. Instances like these raise some questions concerning the role of...
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... | |Original plus 7 copies of the ff: |NA |DATE Received at ERB with Proponent/Investigator/Representative| | | |and ERB secretariat initials | |Endorsement Letter from the research grant if applicable | | | |Accomplished ERB Form 02 -Request for Review of Protocol | | | |Accomplished ERB Form 03- Permit to Conduct the Study and | | | |Informed Consent (English and Filipino) | | | |Accomplished ERB Form 04 – Ethics Review Board Ethical Review | | | |Checklist | | | |CV of PI and Co-investigators/Proponents | | | |GCP and/or...
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... 2006 MEMORANDUM TO: Alex Adams, Ph.D., 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...
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...Running head: APA STYLE: AN EXAMPLE OUTLINE OF A FULL RESEARCH APA Style: An Example Outline of a Full Research Paper Your Name Lewis-Clark State College (TITLE: Must be specific and concise [20 word limit]. Must include variables. Must include mention of population. Do not use jargon. ) Abstract (This is your section header centered on the page) Type your abstract here within APA abstract limits (100-250 words) For a proposal, here, you will state the purpose of your study, the population you are studied, the sample you used, and your method: qualitative or quantitative, instrument (interview, survey, questionnaire, etc.) For a complete paper you would add your summarized findings. Your title (Your title is your section header centered on the page) You will need to bring all your written communication skills to this project. You will be very careful with proper citation. You will not use direct quotes. The whole of this paper is to be in your words. Ideas and information used from other authors are to be cited. Introduction (2-3 pages) First address the problem! State the overall area of concern (populations-at-risk for injustice or discrimination; need for more functional affiliations for individuals and groups; unethical policies/practices; lack of knowledge in the field, etc.). Arouse the reader’s interest; tell the reader what to expect in the rest of your paper. Provide brief statistics to indicate the incidence...
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...to the subject's consent. * IDENTIFICATION OF INVESTIGATORS NOTE: Student researchers, whether PI’s or Co-PI’s, are not required to be identified in this section. If you have any questions or concerns about this research, please contact: (Identify faculty/staff research personnel): Principal Investigator, Faculty Sponsor (if student is the P.I.), Co-Investigator(s), if any. Include daytime phone numbers, and email addresses for all listed individuals. For some studies of greater than minimal risk, it may be necessary to include night/emergency phone numbers. * RIGHTS OF RESEARCH SUBJECTS If you have any questions or concerns about the treatment of human participants in this study, you may call or write: Institutional Review Board Eastern Illinois University 600 Lincoln Ave. Charleston, IL 61920 Telephone: (217) 581-8576 E-mail: eiuirb@www.eiu.edu You will be given the opportunity to discuss any...
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...Process Workflow-Bottlenecks April 23, 2013 Process Workflow-Bottlenecks The bottleneck that I have identified in this process workflow during site initiation process is the time period for when the study will be approved by Institutional Review Board (IRB). The IRB is the regulatory agency that reviews the conduct of the study to ensure the safety and wellbeing of the subject participants during the course of the study. If the approval from the IRB is not obtained, the study or clinical trial cannot begin. Although other activities can be performed in parallel while awaiting IRB approval, the most critical step in site activation such as when the clinical site can begin enrollment will be put on hold if the IRB has not approved the study. Time and money are at stake when there is a delay in site activation. The longer it takes for the site to begin enrollment, the longer it will take for the Sponsor to obtain data from the site. In addition, resources that are allocated for the study are being underutilized as the study awaits approval from the IRB. The down fall in longer approval time from the IRB is that some sites do lose interest or they would have a change in staff that would require the Sponsor to conduct additional training once the site receives IRB approval. Timing of when the other activities such as supply shipments and trainings are all dependent on when the IRB approves the study. Reference Chase, R. B., Jacobs, F. R., & Aquilano, N. J. (2006)...
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...Screen-reader users, click here to turn off Google Instant. Zhang Web Images News Videos Maps MoreSearch tools 1. 2. o o o o o o About 456,000 results (0.44 seconds) Search Results [DOC]CITI Cheat Sheet www.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...
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