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Declaration of Helsinki (1964)
Declaration of Helsinki (1964) [CIRP Note: Ethical research on human subjects into or about the effects of circumcision must be conducted under the provisions of this declaration and those of the Nuremberg Code.] Recommendations guiding physicians in biomedical research involving human subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland,June 1964, amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975, and the 35th World Medical Assembly, Venice, Italy, October 1983. Introduction It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfilment of this mission. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration,"and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient. " The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. In the field of biomedical research a fundamental distinction must be recognised between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research. -
Protecting the Rights of Patients, Nurses, and Others Participating in Research
1.5 ANCC CONTACT HOURS Protecting the rights of patients, nurses, and others participating in research BY JOANN MICK, PhD, RN, NEA-BC Abstract: Clinical nurses are in a unique CLINICAL NURSES are in a unique position to support research that studies position to support research on the the effects of interventions, symptom effects of nursing interventions, management, education, and treatment plan symptom management, education, adherence in their patients. Nurses may also and treatment plan adherence in participate in research studies that aim to their patients. Nurses may also par- advance professional nursing practice. Using ticipate in research studies that aim a quiz format, this article addresses clinical nurses’ role in research, the history of federal to advance professional nursing regulation of research, basic human rights practice. and potential violations during the conduct A fundamental principle of nurs- of research, and specific nursing actions ing practice is respect for the inher- required when research is conducted in the ent dignity, worth, unique attributes, practice setting. and human rights of all individuals.1 Nurses who understand legal and Keywords: Belmont Report, Common Rule, ethical protections for human sub- Declaration of Helsinki, Good Clinical jects can contribute to research by Practice guidelines, human rights, human serving as advocates for their patients subjects protection, Kefauver-Harris and helping to ensure that studies Amendments, Nuremberg Code, thalidomide, Tuskegee study, Willowbrook are conducted in an ethical, legal, State School study and scientifically valid manner. ISTOCK Test your knowledge of the clini- / cal nurse’s role in research by taking ASISEEIT 26 l Nursing2019 l Volume 49, Number 7 www.Nursing2019.com Copyright © 2019 Wolters Kluwer Health, Inc. -
Putting the “No” in Non Nocere: Surgery, Anesthesia, and a Patient's Right to Withdraw Consent
MEDICAL ETHICS Putting the “No” in Non Nocere: Surgery, Anesthesia, and a Patient’s Right to Withdraw Consent CLAUDINE YEE, BS; REBECCA S. HIMMELWRIGHT, BS; WALTER KLYCE, BA; TINA SANKHLA, MD; GEORGE P. BAYLISS, MD THE CASE specifically asking that the procedure be aborted. Many Ms. K is a 53-year-old G2P1 with Stage IIIA endometrial ethics analyses center on the presence or absence of proper cancer who presented to the Women & Infants ambula- informed consent; fewer discuss withdrawal of consent.1 tory surgical unit for a bilateral salpingo-oopherectomy and However, the right to withdraw consent remains a standard lymph node dissection. In the pre-operative unit, a resident component of every informed consent protocol.2,3,4 The UK reviewed the standard informed consent protocol with the Department of Health offers a useful paradigm for such sit- patient, outlining the reasons for the procedure, the risks uations: “A person with capacity is entitled to withdraw and benefits of proceeding, and the risks and benefits of consent at any time, including during performance of a pro- doing nothing. The resident emphasized the necessity of cedure. Where a person does object during treatment, it is surgery to stage the cancer and prevent further spread. Ms. K good practice for the practitioner, if at all possible, to stop appeared anxious, but signed the consent form. The anesthe- the procedure, establish the person’s concerns and explain sia team then proceeded with their evaluation, determining the consequences of not completing the procedure.” It has that she had hypertension, type 2 diabetes, an anxiety disor- in fact been deemed more than just “good practice” for the der, a BMI of 58.2 kg/m2 and a Mallampati Class IV airway practitioner to stop the procedure – in a 2012 case, Pallaco- difficult for intubation. -
Procedures for Research Involving Human Participants
Procedures for Research Involving Human Participants Approved by UNC’s Institutional Review Board March, 2014 Administered By Office of Research Campus Box 143 Greeley, CO 80639 970-351-1910 (voice) 970-351-1934 (FAX) http://www.unco.edu/research/research-integrity-and-compliance/institutional-review-board Table of Contents Preface 3 Purpose of the Institutional Review Board 4 Essentials for UNC Researchers Research Defined 5 Responsibilities (ethical considerations, role of advisor, co-investigators) 5 Research in the Classroom, Pilot Studies, Program Evaluations Considerations for UNC-IRB Approval Overview 7 Review Categories 8 Exempt Expedited Full Board Informed Consent and The Informed Consent Document 15 Standard Informed Consent Documentation Retaining & Storing Signed Informed Consent Documents Waivers to Standard Consent Procedures Research with Children & Other Vulnerable Populations 21 Research with Children – Parental Permission & Participant Assent Additional Considerations Audiorecordings: Exempt or Expedited? 23 Deception: Expedited or Full-Board? 24 Course-Based Research 25 Research Involving Students 25 Data Security……………………………………………………………………..26 Initiation, Continuation, Revision, Conclusion of IRB Approval 27 IRB Non-Compliance and Reported Irregularities during Research 27 Other UNC IRB Procedures That Address Federal Requirements 28 The Ethical Basis of IRB Policy 30 Frequently Asked Questions 33 Consent Document Examples 34 Informed Consent Example 1 (adult participant with signature; suggested for anonymous surveys) Informed Consent Example 2 (adult participant with no signature) Informed Consent Example 3 (parental consent for minor participant) Informed Assent (minor participant) page 2 Preface These policies and procedures were designed to assist faculty, staff, and students at the University of Northern Colorado (UNC) who conduct research with human participants (i.e., subjects). -
Institutional Review Board Governance and Operating Policies
INSTITUTIONAL REVIEW BOARD GOVERNANCE AND OPERATING POLICIES Revised January 8, 2020 Effective January 9, 2020 Table of Contents 1.0 MISSION STATEMENT .................................................................................................. 1 1.1 Institutional Authority under which the is Established and Empowered ........................ 2 1.2 Purpose of the IRB....................................................................................................... 2 1.3 The Principals that Govern the IRB .............................................................................. 2 2.0 THE AUTHORITY OF THE IRB ...................................................................................... 3 2.1 Types of Studies that must be Reviewed ..................................................................... 3 2.2 Disapproving, Modifying, or Approving Studies based on Human Subject Protection ... 3 2.2.1 Actions on Protocols Reviewed by the IRB. .......................................................... 3 2.3 Progressive Reports .................................................................................................... 4 2.4 Monitoring for Compliance ........................................................................................... 4 2.5 Termination or Suspension .......................................................................................... 5 3.0 THE IRB ORGANIZATIONAL STRUCTURE .................................................................. 5 3.1 Administration of the Institution ................................................................................... -
Institutional Review Board (IRB) Handbook of Guidelines and Processes
Institutional Review Board (IRB) Handbook of Guidelines and Processes For the Protection of Human Subjects in Research at Franklin University 2016 Table of Contents INTRODUCTION ........................................................................................................................................... 1 DEFINITIONS ............................................................................................................................................... 1 GENERAL GUIDELINES .............................................................................................................................. 1 IRB STRUCTURE ......................................................................................................................................... 2 IRB RECORDS ............................................................................................................................................. 2 TRAINING REQUIREMENTS ....................................................................................................................... 3 THE REVIEW PROCESS ............................................................................................................................. 3 A. IRB APPLICATION ................................................................................................................................ 3 B. IRB RECEIPT OF THE APPLICATION ....................................................................................................... 4 C. IRB REVIEW ................................................................................................................................... -
Table of Contents Preface
NPR 7100.1B -- TOC Page 1 of 12 | NODIS Library | Program Formulation(7000s) | Search | NASA NPR 7100.1B Effective Date: February 15, Procedural 2019 Expiration Date: February 15, Requirements 2024 COMPLIANCE IS MANDATORY FOR NASA EMPLOYEES Protection of Human Research Subjects Responsible Office: Office of the Chief Health & Medical Officer SPECIAL ATTENTION: ONLY USE NID 7100.133, Protection of Human Research Subjects. Table of Contents Preface P.1 Purpose P.2 Applicability P.3 Authority P.4 Applicable Documents and Forms P.5 Measurement/Verification P.6 Cancellation Chapter 1. Introduction 1.1 Human Subject Research at NASA 1.2 Common Rule Implementation Chapter 2. Criteria for NASA Institutional Review Board (IRB) Approval 2.1 Criteria for all Research 2.2 Additional Criteria for Human Research Genetic Testing Chapter 3. NASA Specific Requirements 3.1 Research Modifications This document does not bind the public, except as authorized by law or as NPR 7100.1B -- TOC incorporated into a contract. This document is uncontrolled when printed. Check Page 1 of 12 the NASA Online Directives Information System (NODIS) Library to verify that this is the correct version before use: https://nodis3.gsfc.nasa.gov. NPR 7100.1B -- TOC Page 2 of 12 3.1 Research Modifications 3.2 Medical Data 3.3 Withdrawal from Research 3.4 Adverse Events 3.5 Sanctions and Disciplinary Action Appendix A. Definitions Appendix B. Acronyms Appendix C. References This document does not bind the public, except as authorized by law or as NPR 7100.1B -- TOC incorporated into a contract. This document is uncontrolled when printed. -
Protecting Human Research Participants NIH Office of Extramural Research Introduction
Protecting Human Research Participants NIH Office of Extramural Research Introduction Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. Who? This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research. What? This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Why? As a part of NIH's commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000. -
2018 Common Rule Frequently Asked Questions (Faqs)
Institutional Review Board Human Research Protections 2018 Common Rule Frequently Asked Questions (FAQs) Version January 25, 2019 General Questions Relating to the Common Rule 1. WHAT IS THE COMMON RULE? The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations. The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. -
Guidelines for Human Biospecimens Storage and Tracking 12913
Guidelines for Human Biospecimen Storage, This Photo by Unknown Author is licensed under Tracking, CC BY-ND Sharing, and Disposal within the NIH Intramural Research Program September, 2019; Revised May, 2021; Revised September, 2021 1 Contents Preface ....................................................................................................................................... 3 Introduction ............................................................................................................................... 4 Definition of Human Biospecimens ............................................................................................. 4 1. Legal and ethical considerations ............................................................................................. 6 2. Collection and storage ............................................................................................................ 7 3. Inventory database systems and tracking ................................................................................ 9 4. Quality management practices including standard operating procedures .............................. 10 5. Custodianship ....................................................................................................................... 10 6. Disposal, sharing, or release of NIH biospecimens .............................................................. 11 7. Shipping .............................................................................................................................. -
JSC Committee for the Protection of Human Subjects Guidelines for Investigators Proposing Human Research for Space Flight and Related Investigations
JSC 20483 Revision C JSC Committee for the Protection of Human Subjects Guidelines for Investigators Proposing Human Research for Space Flight and Related Investigations Space and Life Sciences Directorate Before use, verify that this is the correct version (Verification on JSC ISO-9000 Internet Site http://stic.jsc.nasa.gov/dbase/iso9000/master/master.cgi) February 2004 National Aeronautics and Space Administration Lyndon B. Johnson Space Center Houston, TX 1 JSC 20483 Revision C Johnson Space Center (JSC) Committee for the Protection of Human Subjects (CPHS) Guidelines for Investigators Proposing Human Research for Space Flight and Related Investigations Approved by:___Original signature on file_________________ ________ C. F. Sawin, Ph.D. Date Chairperson, JSC Committee for the Protection of Human Subjects (CPHS) Concurrence:__Original signature on file__________________ _______ J. R. Davis, M.D. Date Director, Space and Life Sciences Concurrence:__Original signature on file_________________ _______ R. Cabana Date Director, Flight Crew Operations 2 JSC 20483 Revision C JSC Work Instruction Title: JSC CPHS Handbook 20483 Revision: Revision C Date: February 2004 Handbook Revision Process This Handbook has been reviewed by each major organizational element involved (denoted by Handbook signature page). Requests for changes shall be submitted in writing to the Director for Space and Life Sciences. The quality record for this review and update process will be the current document with the appropriate updated revision number and date, signed by the Director, Space and Life Sciences. The Director, Space and Life Sciences, can update the document within any fiscal year as required, and will provide notification that a new version is available. -
Is This Human Subjects Research? Do I Need Irb Review?
IS THIS HUMAN SUBJECTS RESEARCH? DO I NEED IRB REVIEW? A Guide for Researchers baylor.edu/research This booklet, prepared by the Office of the Vice Provost for Research—Research Compliance, provides guidance to Baylor University investigators who may be uncertain if their study meets the definitions of human subjects research stated in the federal regulations (45 CFR 46.102). Is This Human Subjects Research? Do I Need IRB Review? offers researchers an explanation of the definitions as well as examples of studies that do or do not qualify as human subjects research. For further information, please refer to the Resources section on page 9 of this booklet. Credit is given to the University of Southern California Office for the Protection of Research Subjects (OPRS) for the concept and as a primary source of information. Office of the Vice Provost for Research TABLE OF CONTENTS Human subjects research ....................................................4 How do I identify human subjects research studies? ..............................5 Studies that are NOT human subjects research...................................6 Non-human subjects research examples........................................7 Human subjects research examples ...........................................8 Is an exempt determination the same thing as a non-human subjects research determination? .....................................................8 Resources ................................................................9 Contact us ...............................................................10 baylor.edu/research HUMAN SUBJECTS RESEARCH Research projects involving human subjects require review by an Institutional Review Board (IRB). An IRB is an ethics committee of scientists and non-scientists who assure that the rights and welfare of human subjects are adequately protected in research. The BU IRB is responsible for reviewing and overseeing human subjects research conducted by BU faculty, staff and students.