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 Mission Clinical Ethics Consultation Service Research Ethics Consultation Service Ethics Resource Center Principles of Ethical Conduct Institute for the Medical Humanities Institutional Ethics Committee |
Research Ethics Consultation ServiceThis service to the UTMB research community is supported by a President's Cabinet Award. The consultation service is intended to compliment the work of the Institutional Review Board, which is the authoritative body for reviewing any research involving human subjects at UTMB. The Institutional Review Board is usually called, "the IRB".All UTMB research that involves human subjects must be approved by the IRB. In deciding if they can approve a research project (the protocol), the IRB follows the rules the U.S. Government has set up to protect people who take part in research. These rules are found in: The Code of Federal Regulations: Title 45, Part 46. For Food and Drug Administration (FDA) regulations, see: The Code of Federal Regulations: Title 21, Part 50. Learn more about research at UTMB at the following websites: What is a 'clinical research ethics consultation'?A 'consultation' happens whenever one person asks someone else (the 'consultant') for help or advice. In this case, for help or advice about a question or situation that has to do with clinical research involving human subjects. If you have a doubt, concern, question or any issue at all that you think someone trained in clinical research ethics might be able to help you with, then this service is here for you.Why is there a Research Ethics Consultation Service at UTMB?There has been much growth in the amount of clinical research being done in recent years. Along with this growth has come increased public awareness of research being done, and the potential for serious harm to people that volunteer to be subjects in research. This has led to questions as to how much the public trusts researchers to protect human subjects.Compliance and regulation have an essential role in protecting human subjects in research. But compliance needs to be seen within the larger context of an institution's culture in order to more fully affirm that the research community is worthy of the public's trust. When a university's culture routinely pursues excellence, integrity, service to the community and moral accountability in its projects, then rules and regulations that command compliance fit comfortably within this larger ethical framework. Here science and ethics are not in conflict, but inform one another and work together to nurture strong relationships in a community of care, mutual trust, and professional accountability. UTMB, in pursuing its mission, vision and values, is committed to nurturing these relationships and values within its research community through innovative education and service. An important tool to help further this work is the UTMB Research Ethics Consultation Service:
What kinds of things could the UTMB Research Ethics Consultation Service help me with?
What are some specific examples of situations where the consultation service might be an appropriate place to turn to for help?Here are just a few possible examples:
Who can ask for a research ethics consultation?ANYONE involved with research and/or its regulation at UTMB may request consultation, including:
How would someone request a consultation?Call the director at (409) 772-1208. If you are on campus, just dial: 21208.Where is the UTMB Research Ethics Consultation Service located?In the UTMB Hospital - John Sealy Towers, 5th Floor - Room 5.106When can a consultation be requested?You can call the director at any time and leave a message with your full name and how you can be reached. Your message will be responded to between 8:00 a.m. and 5:00 p.m. the following day if possible.If you have an urgent or emergency situation you need to contact UTMB Research Services at (409) 772-3481. If you are on campus, just dial: 23481. Who are the UTMB Research Ethics Consultants?
DEFINITIONS:What is 'research'?"Research means a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge." This is the definition found in Title 45, Part 46:102 - Code of Federal Regulations. The Code of Federal Regulations are the guidelines the government uses to make sure that research is done in the proper way - to make sure that there is a good reason for doing the research, and to make sure that no one is harmed because of it.What is a 'systematic investigation'?If you're curious about how something works, or why something is the way it is, one way to learn more about it is to investigate it - look at it more closely in a thorough way. If you look at something more closely by using the method that science uses, then your investigation is systematic because it will have a reason behind it, and a method of learning more about whatever it is you are studying.What is 'generalizable knowledge'?This means that whatever you learn about the particular thing you're studying applies to a broader picture as well. You could say, for example, "If it is true for these people that I have been studying, then it is probably true for a larger population as well." The knowledge gained can be generalized to apply to more people than the particular ones that took part in a study.So research is the same as doing an experiment?Not exactly. They are similar because you set out to learn something that you don't know by comparing it to what you do know, and by testing out an idea you have that might be true. But research means that the way you go about learning something is organized, makes good sense, and is worth doing based on the experience of people who have done research before you. An experiment can be a part of research, but research is something much more than a particular experiment.And 'Clinical Research' means?Clinical research means any study that's done about people and their health or illness. The word, 'clinical', refers to a medical setting, but means more than just a doctor's office or the hospital. It's used to talk about anything having to do with the observation or treatment of people in a healthcare setting. Clinical research is the way people learn about sickness and health.What does 'human subject' mean?"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: 1.) Data through intervention or interaction with the individual, or, 2.) Identifiable private information. This is the definition found in Title 45, Part 46:102 - Code of Federal Regulations. (see above for an explanation of the Code)In other words, a human subject is a living person who, (along with other people), is the focus of some particular research project. Human subjects might be patients who are ill, or they might be healthy people who volunteer to be a subject of research. An 'investigator' is the person doing the research. The 'human subject' is the person who is being studied. 'Data' means any information that is learned in the study. 'Intervention or interaction' means any direct contact the person doing the research has with the human subject. 'Identifiable private information' means any information that the human subject would normally consider private, and that can be tied directly to the person it is about. What does 'ethics' mean?A very simple answer is that 'ethics' means what is right or wrong, good or bad - especially when it has to do with what people do. Right and wrong, good and bad mean very different things to different people in different situations. But there are some guidelines, or principles of 'ethics', that most people can agree on most of the time.Codes of EthicsSince World War II there have been three major "Codes of Ethics" that apply directly to research involving human subjects. These codes are listed below. They are based on general principles of ethics that most people agree are very important to keep in mind at all times in doing research that involves people.
What are some examples of 'principles of ethics' that most people agree on?There are three important ones in particular for talking about research with human subjects. Please click here: The Belmont Report to read more about these three principles. Here are some very basic definitions:
Research Subject Bill of Rights:The rights below are the rights of every person who is asked to be in a research study:
Educational Resources for Human Subjects Protections, Scientific Integrity, and the Responsible Conduct of Research: HHS, NHLBI, NIH: Who Needs Human Subject Protections Training? NIH Office of Human Subjects Research: Researcher Computer-Based Training NCI: Human Participant Protections Education for Research Teams UCLA: Stanley G. Korenman book: Teaching the Responsible Conduct of Research AAAS / NAS: Scientific Integrity Program UTMB GCRC CREO: Tools and Techniques for Clinical Research: Ethics Module UTMB Data & Safety Monitoring Planning Computer-Based Course Government Resources and Federal Regulations: Institutional Review Board Guidebook NIH Roadmap NLM listing of currently active clinical trials RegSource Regulatory Page HHS Code of Federal Regulations: Browser HHS Code of Federal Regulations: Protection of Human Subjects HHS: Office for Human Research Protections HHS: Office of Research Integrity HHS: HIPAA regulations FDA: Protection of Human Subjects FDA: Good Clinical Practice in FDA-Regulated Clinical Trials FDA: Guidance for Institutional Review Boards and Clinical Investigators NIH: Bioethics Resources on the Web NIH: Office of Human Subjects Research NIH: HIPAA regulations NIH: Office of Biotechnology Activities - Recombinant DNA and Gene Transfer Helpful Websites for Developing a Data and Safety Monitoring Plan: Adverse Event Reporting on Patient Safety at UTMB Adverse Event Reporting of Events with Human Subjects at UTMB UTMB Data & Safety Monitoring Planning Computer-Based Course HHS OHRP: Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events NIH Guidelines for Adverse Event Reporting NIH Guidelines for Data and Safety Monitoring Further NIH Guidance on Data and Safety Monitoring for Phase I and Phase II Trials National Center for Complementary and Alternative Medicine National Cancer Institute National Cancer Institute Guidance for Conducting Clinical Trials National Heart, Lung and Blood Institute National Heart, Lung and Blood Institute National Heart, Lung, and Blood Institute National Heart, Lung and Blood Institute National Institute on Aging National Institute of Allergy and Infectious Diseases National Institute for Arthritis and Musculoskeletal and Skin Diseases National Institute for Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Mental Health National Institute of Neurological Disorders and Stroke University Websites and Centers for Bioethics: Johns Hopkins University Bioethics Institute Washington University Medical Center: Human Studies Committee University of Toronto Joint Centre for Bioethics Michigan State University Center for Ethics and Humanities in the Life Sciences University of Pennsylvania Center for Bioethics The Hastings Center: An Independent Bioethics Research Organization The Medical College of Wisconsin Center for the Study of Bioethics Kennedy Institute of Ethics at Georgetown University Websites of Interest to Principal Investigators and Research Teams: NIH: Human Participant Protections Education For Research Teams (online course) National Library of Medicine: Gateway Search Page Public Responsibility in Medicine and Research Centerwatch Clinical Trial Listing Service Drug Information Association BioSpace: Web Solutions for the Life Sciences The National Academies Institute of Medicine The National Academies: Science, Engineering and Medicine National Institutes of Health Homepage American Medical Association Ethics Program GCRC: Society of Research Subject Advocates Canadian Institute of Health Research: Ethics Training Grant Website The Greenwall Foundation Faculty Scholars Program in Bioethics Friends Research Institute Kluwer Online: research related publications National Academies Press: Institute of Medicine publication "Integrity in Scientific Research." NORD: National Organization for Rare Disorders Association of American Medical Colleges NIH: National Center for Research Resources Society for Research Subject Advocates: Bioethics Reading List Society for Research Subject Advocates: Useful Links MedicineNet: Medical Dictionary Stanford RCO: Glossary of Lay Terms for Use in Preparing Consent Forms HHS OHRP: Frequently Asked Questions About Research with Children HHS OHRP: Frequently Asked Questions about Human Subject Research UTMB Research Listserv International Human Subjects Research: Canadian Institute of Health Research International Conference on Harmonization The World Medical Association Office for Human Research Protections Of Interest to Human Subjects of (Participants in) Biomedical Research: National Institutes of Health / National Library of Medicine: Information about Clinical Trials Centerwatch Clinical Trial Listing Service Public Responsibility in Medicine and Research National Institutes of Health Homepage DHHS: Office for Human Research Protections FDA: Protection of Human Subjects National Library of Medicine: Gateway Search Page
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