The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (2001) – A report by the HHS Office of the Inspector General that examines protection of human subjects in commercially sponsored drug research that is conducted overseas. The report notes an increase in such research and recommends that the US government and industry obtain more information about foreign ethics review committees, build capacity to review and monitor such research so that human subjects are more adequately protected, and encourage registration and accreditation of foreign ethics review committees.
ClinicalTrials.Gov – ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. The site provides information about a trial's purpose, who may participate, locations, and investigator contacts. This NIH site provides an introduction to clinical trials for the layperson.
Ethics in Clinical Research (NIH) – This NIH resource links to codes of ethics that guide research. Using these sources of guidance and others, seven main principles are described that guide the conduct of ethical research. The site links to other resources about clinical research and clinical trials.
Ethics & Clinical Trials (NLM Gateway) – This link accesses journal articles, meeting abstracts, consumer information and databases that reference ethics and clinical trials. Although only some of the references are likely to be useful, the site is updated frequently and is therefore a valuable resource.
What Makes Clinical Research Ethical? –- (2000) This article by staff of the NIH Department of Clinical
Bioethics proposes 7 requirements as a coherent frame-work for evaluating the ethics of clinical research studies: (1) value enhancements of health or knowledge must be derived from the research; (2) scientific validity; (3) fair subject selection; (4) favorable risk-benefit ratio within
the context of standard clinical practice and the research protocol;
(5) independent review; (6) informed consent; and (7)
respect for enrolled subjects
PUBMED: Ethics and Clinical Trials – References and abstracts for journal articles on clinical trials management, oversight and ethical issues.
NIH Clinical Research Policy Analysis & Coordination: Resources/Tools – This NIH Office that optimizes policies for the conduct and oversight of clinical research posts resources and tools on topics such as: clinical trials design, clinical trial monitoring, reports on genetic modification, clinical research, informed consent, models of IRB review, and the Health Portability and Accountability Privacy Rule and information on protection of human subjects in research.
NIH Policy for Data Safety and Monitoring in Clinical Trials (1998) -NIH requires that each Institute and Center (IC) has a
system for oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials. The establishment of data safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional
Review Board (IRB).
Guidance on Reporting Adverse Events to Institutional Review Boards (IRBs) for NIH-Supported Multicenter Clinical Trials (1999) – This NIH policy requires data-safety monitoring boards for multisite clinical trials to forward summary reports of adverse events to IRBs involved in the study.
NIA Guidance on Research with Human Participatnts (updated 2006) – This site links to NIA-specific policies for protection of human subjects including Guidance for Research on the Genetics of Alzheimer’s Disease and a link to the NIH OER Human Subjects Web Site.
Clinical Trials Education (NCI) - The Clinical Trials Education Series is designed for cancer patients, health professionals, and the general public. It consists of educational materials (books, booklets, slides, videos) that can be viewed online or ordered in print. The materials include information on protection of human subjects for patients and for professionals.
Protecting-Participants in Clinical Trials (NCI) - This NCI resource links to information about how participants in clinical trials are protected before and during the conduct of a study. Resource documents on the page include: A Guide to Informed Consent, Children's Assent to Clinical Trial Participation, Simplification of Informed Consent Documents, questions and answers about clinical trials and other materials.
Clinical Trial Regulations, Policies and Guidance – This NIDA page contains useful links to information about requirements and good practices related to clinical trials using biomedical and behavioral interventions and including research with special populations.
Clinical Trial Registration (ICMJE 2004) – A policy requiring clinical trial registration was implemented by the International Council of Medical Journal Editors in 2004. Its intent is to make information about trials and their outcomes available to the public and to discourage selective reporting of results. The definition of a clinical trial and the policy were updated in 2006 and 2007. Details and the registration criteria may be accessed at http://www.icmje.org/. MacMaster University provides a summary of the policy and frequently asked questions about clinical trials registration.
The Advancement of Clinical Trials (2007) – This article from the FDA Consumer Magazine defines controlled clinical trials and summarizes why and how trials are conducted according to current best practices. The site includes a time-line that outlines key events in the development of controlled clinical trials.
Clinical Trials (FDA) – This FDA site links to regulations and other information about clinical trials, such as protection of human subjects, data and safety monitoring, educational materials for trial participants and investigators, policies regarding inclusion of population groups, conduct of trials for particular diseases, trial registries and other information.
Proposed Regulations and Draft Guidances on Good Clinical Practice and Clinical Trials (2007) – This site lists draft guidance and regulations on which the FDA seeks comments. The links are listed by publication date, starting with the most recent and go back to 2003. Although not all deal with ethical issues, they provide a good summary of concerns associated with clinical trials.
Good Clinical Practice in FDA-Regulated Clinical Trials – This site links to the FDA Good Clinical Practice program that deals with issues arising in human research trials regulated by FDA. The program coordinates FDA policies, participates in and coordinates FDA's Human Subject Protection/Bioresearch Monitoring program, contributes to international Good Clinical Practice harmonization activities, conducts training and outreach programs, and serves as liaison with OHRP and other organizations committed to the protection of human research participants.
Pediatric Therapeutics (FDA) – The FDA Office of Pediatric Therapeutics ethics page links to regulatory and policy documents, committees and working groups and to an FDA Peds Ethics Listserve.
Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards (2005) - These Operational Guidelines provide guidance to health research sponsors for the establishment and functioning of data and safety monitoring boards (DSMBs). The guidelines are based on a review of existing guidances and requirements for DSMBs from national and international organizations, as well as on observation of existing practices of DSMBs in different countries and institutions.
Communication, Relationships Key to Minority Community Clinical Trial Participation – A publication resulted from a meeting and engagement with minority community members to explore reasons underlying low participation in clinical trails by minority communities. The report on the Health Partnership Program describes the importance of trust between researchers and community members and the conditions in which minority community members are likely to participate in clinical research. Grady C, et. al. Exploring the ethics of clinical research in an urban community. Amer. J. Public Health 2006;96(11):1996-2001.
Learn About Clinical Trials – A University of Michigan Cancer Center site that educates users about clinical trials, links to other resources, and can be searched for information about ethical issues.
Ethical and Legal Aspects on Clinical Trials with Children (2004) – This site links to a selected bibliography from the Karolinska Institute University Library. Several European organizations contributed to the document. Not all references are in English.
Clinical Trials Toolkit (UK) - This site has been developed by the UK Medical Research Council and Department of Health primarily for clinical trialists and R&D managers working in the academic sector, but will also be of use to other health professionals. It was developed for guidance in compliance with UK regulations and to implement the EU Clinical Trials Directive in the UK (Regulations were amended in 2006 and the site will be updated to reflect changes). The information is organized into Route Maps and includes information on ethics. Although designed for the UK, the site is relevant to clinical trials and research more generally. There are links to other resources.
The Society for Clinical Trials - The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies. This site lists publications, relevant meetings and position papers.
Ethical Issues for Cancer Prevention Oncology Trials: Considerations for IRBs and Investigators – This article analyzes some of the ethical issues in chemoprevention research and is directed toward investigators writing the protocols for phase III chemoprevention trials and Institutional Review Board (IRB) members reviewing such protocols. Issues addressed include subject selection, including justifications for identifying and recruiting at-risk subjects; the determination of the social value of chemoprevention research; and informed consent and payment to research participants. Examples come largely from breast cancer chemoprevention trials but the implications of the analysis are generalizable to other areas of chemoprevention research.
