Documents about Involving Human Subjects

  • 35 Pages


    Pittsburgh, SUPER 7

    Excerpt: ... Public Health & Primary Care Unit Paraclinical Sciences Faculty of Medical Sciences UWI, St Augustine, T&T Ethics in research involving human subjects presented by: Celia M Poon-King medical epidemiologist lecturer in epidemiology 3 what do you know? what do you think you need to know? why? 3 3 05/15/09 ethics in research involving human subjects 2 Outline 3 history knowledge - principles, IRB attitude 3 3 05/15/09 ethics in research involving human subjects 3 Outline 3 skills - application framework of principles 3 practice - learning objectives, research project 05/15/09 ethics in research involving human subjects 4 History 3 1947 - Nuremberg code 05/15/09 ethics in research involving human subjects 5 History 3 1964 - Helsinki declaration 05/15/09 ethics in research involving human subjects 6 History 3 1979 - Belmont report 05/15/09 ethics in research involving human subjects 7 History 3 1993 - CIOMS 05/15/09 ethics in research involving human subjects 8 ...

  • 1 Pages


    Cornell, D SOC 101

    Excerpt: ... DSOC 1101 Response Paper #2 Due in section the week of February 9, 2009 In 1-2 typed, doubled-spaced pages, answer one of the following: 1. According to your textbook, what are two things sociologists do when asking questions and seeking answers that set their inquiry apart from the common sense or mere speculation of the average non-sociologist? 2. The Belmont Report proposes three criteria for the evaluation of research involving human subjects , respect for persons, beneficence and justice. Based on the film, Deadly Deception, describe how the Tuskegee Study failed to conform to each of these criteria. ...

  • 5 Pages


    UCLA, EPIDEM 227

    Excerpt: ... Initiated: 1964 17.C Original: English WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002 A. 1. INTRODUCTION The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects . Medical research involving human subjects includes research on identifiable human material or identifiable data. It is the duty of the physician ...

  • 1 Pages


    Lincoln U. MO, K 55

    Excerpt: ... Research Note Be sure to recognize that if you propose a research study which involves human subjects, you will need to apply for and receive approval of your study from the Universitys Institutional Review Board (IRB). This does not apply if you are ...

  • 4 Pages


    SUNY IT, IDT 599

    Excerpt: ... PROPOSAL FOR RESEARCH INVOLVING HUMAN SUBJECTS SUNY Institute of Technology Marcy Campus, P.O. Box 3050 Utica, New York 13504-3050 Title and Number of Research: Submitted by: Date: -COMMITTEE ON INVESTIGATIONS INVOLVING HUMAN SUBJECTS Please complete the following and return this form to the above address, along with eight (8) copies of the proposal. Use additional sheets, in necessary. N.B. Grant proposals for research involving human subjects must be reviewed and approved by the committee before submission to the funding agency. TITLE OF PROPOSAL: 1. Objectives of Research Study A. A summary statement of the proposal including the generic problem or question to which the study is addressed (not specific hypothesis or procedures) written in language understandable to a layperson. SUMMARY STATEMENT: B. For training grant proposals, indicate who (other than the trainees) will be responsible for con ...

  • 1 Pages


    UNC, ENVR 431

    Excerpt: ... ENVR431 Fall 2008: Research with Human Subjects October 22, 2008 The following questions can be answered by reference to the UNC Office of Human Research Ethics web page ( follow link on course website). 1) What is the entity at UNC-CH that oversees research that involves human subjects ? 2) What is the entity at UNC-CH that reviews protocols for research that involves human subjects ? 3) What is the Federal entity that oversees research involving human subjects ? 4) What is a human subject ? 5) What is The Common Rule ? 6) What are vulnerable populations ? 7) What is informed consent, and how is it obtained ? ...

  • 2 Pages


    Alaska Anch, STAT 107

    Excerpt: ... Chapter 7: Data Ethics Reasonable people disagree about the dicult/subtle cases involving data ethics. There are, however, some widely agreed upon basic ethical principles for statistical studies. First Principles of Data Ethics 1. Institutional Review Board The organization conducting the research must have an Institutional Review Board that reviews all studies involving human subjects in order to protect the subjects from possible harm. The purpose of the review board is not to decide whether a proposed study will produce valuable information or whether it is statistically sound. 2. Informed Consent All individual subjects must give their informed consent before data are collected. Subjects must be informed in advance about the nature and purpose of the study and any risk of harm posed by participation. Subjects must then consent, usually in writing, to participation in the study. 3. Condentiality All individual data must be kept condential. Only statistical summaries for the group of subjects may ...

  • 2 Pages


    JMU, POSC 295

    Excerpt: ... a. fair selection of subject b. who should hear the risk of a study, who is equal and who is not, who should receive its benefits c. the concept of justice may be questioned when we attempt to decide who will be given an opportunity to participate and who (and for what reason) will be excluded d. Justice is a difficult and complex ethical issue. However, attempt it at all times to distribute the risks and benefits fairly and without bias. G. Common Rule 1. 1981-1991: Federal Government established regulations based on the Belmont Report 2. 1991: all federally sponsored research is covered by a common set of regulations 3. 45 CFR 46: The Common Rule H. Research 1. The IRB only reviews research involving human subjects . 2. RESEARCH is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizeable knowledge. Any forethought of publication is research. I. Levels of IRB Review 1. Exempt Status a. Only 1 IRB has to approve this b. Human ...

  • 12 Pages

    AR II-4-0-4_Complete

    Kentucky, NEW 20071001

    Excerpt: ... includes any tangible or intangible inventions, discoveries, patents, or ideas necessary for development, utilization or processes associated with the activity. F. "Significant Financial Interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). For research involving human subjects , "significant financial interest" also includes employee or executive relationships with entities that have a financial interest in the research even when no remuneration is involved. The term does not include any of the following: 1. Salary, royalties, or other remuneration from the University; AR II-4.0-4 9/19/95 Page 3 2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; 3. Income from service on advisory committees o ...

  • 5 Pages


    University of the West Indies at Mona, B 965

    Excerpt: ... records: Will subjects know their records are being consulted? Yes 3 3. Information to Subjects Section VI, Item F, of the University of Windsor Guidelines on Research Involving Human Subjects states: "Deception is a situation in which subjects have essential information withheld and/or are intentionally misled about procedures and/or purposes. Explaining only the general purposes of the research (eg. To learn more about how people in your community feel bout.), without elucidating specific purposes, does not constitute deception". Essential information about the procedures and purposes of the study should normally be provided to each subject in a signed consent form. Therefore in general, subject to the provision of Section VI, Item F, cited above nothing may be withheld which might, if divulged, affect subjects' decision to participate. However, deception (as defined above) will be permitted in clearly justifiable circumstances. Indicate which of the following describes the research: 1. 2. 3. Subjects ...

  • 10 Pages


    Ill. Chicago, SOFIA 2003

    Excerpt: ... arch Involving Human Subjects , written by the Council for International Organizations of Medical Sciences, does not exclude placebo trials when an effective treatment exists, as does the Declaration of Helsinki. It does stipulate that the investigator must justify the research in relation to the expected benefits to society while minimizing any risk to the individuals involved. ! Recommendations of the Declaration of Helsinki prevail in Serbia. FOLLOW-UP AND MONITORING OF THE TRIAL ! The main role of research ethics committees is to assess both the scientific and ethical aspects of submitted protocols. ! Ethical committees are responsible not only for approval of the protocol and its amendments but also for follow-up and monitoring of the trial after its closure. This last commitment is rarely fulfilled because of lack of time and resources assigned to the ethics committee. RESEARCH ETHICAL COMMITTEES IN SERBIA An analysis of the work of research ethical committee at the University Clinical Center in Nis ...

  • 29 Pages


    Shoreline, MATH 107

    Excerpt: ... approval of research involving human subjects . Before any research involving human subjects can be initiated it must have received HSRB review and approval. The activities of the HSRB are administered by the Office of Research Compliance (ORC). Case-Control Studies*: An Alternative to Experimental Studies To examine the possible relation of an exposure to a certain disease, we identify a group of individuals with the disease (called cases) and a group of individuals without the disease (called controls). Then we determine what proportion of the cases were exposed and what proportion were not. We also determine what proportion of the controls were exposed and what proportion were not. *This differs from the definition in the book, which is wrong. What they are defining is known as a cohort study. My reference is Leon Gordis', "Epidemiology," W.B. Saunders, Hancourt Brace, 1996, pp. 124 125. Case-Control Studies: An Alternative to Experimental Studies Exposed a Not Exposed c Exposed b Not Exposed d Disea ...

  • 58 Pages


    Cornell, PHIL 2450

    Excerpt: ... Atul Gawande's piece (in section this week) Contemporary issues in informed consent Tuskegee syphilis Experiments 1932-72 Alabama (US Public Health Service) Government radiation studies 1944-74 Use of bio-warfare vaccines without consent of military personnel in the Gulf war. AIDS experiments in the developing countries Informed Consent and Human Research Codes The National Commission grounded requirement of informed consent in the ethical principle that includes that -individuals be treated as autonomous agents -individuals with diminished autonomy have the right to protection. WHO/CIOMS Proposed International Guidelines for Biomedical Research Involving Human Subjects Informed Consent and Human Research Codes Experiments that involve human subjects are required to meet certain guidelines. The Nuremberg Code identifies attributes of consent: consent must be "voluntary", "legally competent" and "informed". CIOMS guidelines for use of subjects in developing countries Protection of subject ...

  • 3 Pages

    Sunstein 3

    Arcadia University, ED 110.B

    Excerpt: ... ure). Comment on your list as described by Mimi Harvey in Box 12 (136-138). You might also look ahead to the handout from Ruby Payne's Framework For Understanding Poverty for this as well. Age College experience Family experience Only child Middle-Class family Math Skills Paycheck 8. How did Karen Dowling negotiate her entry into her Photo Phantasies Fieldwork? (138-139) Karen sent in a letter stating her intentions and reasoning for doing the fieldwork. She then had to wait for permission from the board to allow her to do so. She then had to find a time best suitable for Ginny, the store manager. 9. Explain the 3 major principles relevant to the research involving human subjects Respect for Persons Informants should only participate voluntarily. They should not be pressured into offering more time than they have. Beneficence- Researchers should protect informants against risk from harm or from the loss of any benefit. All profits must be shared or the story cannot sell. Justice- Informants must be selected ...

  • 4 Pages


    UC Davis, MANUALS 230

    Excerpt: ... Section 230-05 Exhibit A 6/16/08 Procedures for Reporting, Reviewing, and Managing Conflicts of Interest in Research This document describes the process for reporting, reviewing and managing potential conflicts of interest in sponsored research and educational activities, including the process for disclosing financial interests, the referral of positive disclosures to the Conflict of Interest Committee, the process for reviewing positive disclosures, and the establishment of management plans for managing, reducing or eliminating conflicts of interest in sponsored research and educational programs, including research programs involving human subjects . All principal investigators and key personnel must disclose their financial interests and the financial interests of their spouses/domestic partners and dependent children on the appropriate disclosure form(s) (as indicated below) whenever submitting a proposal for a sponsored project. I. Initial Disclosure by Principal Investigators A. Principal investigators s ...

  • 4 Pages


    Midwestern State University, MEMO 18

    Excerpt: ... OGRD MEMO #18 June 1, 1992 Washington State University Guidelines on the Administration of Ethyl Alcohol in Human Experimentation Introduction Research on the biological and behavioral effects of the ingestion of ethyl alcohol is often conducted on human subjects. Consistent with the National Advisory Council on Alcohol Abuse and Alcoholism, the University recognizes the legitimate and important need for research involving human subjects . Only through research can we fully understand the actions of alcohol including tolerance, dependence and reinforcement and develop treatment programs for alcoholism. It is essential that such research conform to the (ethical) principles that govern all research involving human subjects . The ethical considerations underlying the justification for using alcohol in human research result from the fulfillment of three fundamental principles: obtaining fully informed and voluntary consent from the subject, insuring that benefits will result to the subject and harm will not occur, ...

  • 38 Pages


    N.E. Illinois, AY 20082009

    Excerpt: ... EASTERN ILLINOIS UNIVERSITY THE GRADUATE SCHOOL OFFICE OF THE DEAN Robert M. Augustine, Dean 1201 Blair Hall TO: Council of Deans Council on Academic Affairs Council on Graduate Studies Council on Teacher Education Transition to CITI Protection of Human Subjects Program February 26, 2009 Phone: Email: 581-2220 RE: DATE: Eastern's Institutional Review Board (IRB) policy requires that all faculty, staff, and students planning research involving human subjects complete an on-line training course on the protection of human subjects in research. Currently this is handled via an in-house training program. Following a thorough study, the IRB determined that an on-line program called CITI, available by subscription from the University of Miami, provided a better training program. The CITI program is more extensive and flexible than our in-house program and can be customized to meet our specific needs. In addition, the CITI program automatically updates the course content semi-annually and prov ...