“A systematic investigation designed to develop or contribute to generalizable knowledge” [38 CFR 16.102 (d), 45 CFR 46.102 (d)] [Clinical investigation means any experiment that involves a test article and one or more human subjects… The terms research, clinical research, clinical study, study and clinical investigation are deemed to be synonymous… 21 CFR 50/56]
A living individual about whom an investigator… conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information [38 CFR 16.102 (f), 45 CFR 46.102 (f)] [Human subject… an individual who is or becomes a participant in research, either as a recipient of the test article or as a control…. may be either a healthy individual or a patient. … 21 CFR 50/56]
Association for Assessment and Accreditation of Laboratory Animal Care, International - A private, nonprofit organization that promotes the humane treatment of animals in science through a voluntary accreditation program. It is the accrediting body for animal research programs recognized by the VA for VA animal research. Website: www.aaalac.org
Association of American Medical Colleges - An organization whose mission is to improve the health of the public by enhancing the effectiveness of academic medicine. They support institutions, organizations and individuals associated with academic medicine in: Educating the physician and the medical scientist workforce; Discovering new medical knowledge; Developing innovative technologies for prevention, diagnosis and treatment of disease; Providing health care services in academic settings. Website: www.aamc.org
Applied Research Ethics National Association - A national service organization for professionals concerned with issues relating to the protection of human subjects, the humane care and treatment of animals, scientific misconduct, ethical decision-making in healthcare, and other ethical issues pertaining to biomedical and behavioral research. Its mission is the promotion of networking among its members, the development of educational activities, the resolution and/or amelioration of mutual problems, and the professional advancement of its members in order to enhance the ethical conduct of research and medicine. Website: www.primr.org/membership/overview.html
A report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The report describes some basic ethical principles and guidelines for the protection of human subjects participating in research. The three ethical principles discussed are: Respect for persons Beneficence Justice
Code of Federal Regulations - This is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal government. The Code is divided into 50 titles that represent broad areas subject to Federal regulation. For research conducted at the VA, the titles that would most frequently apply are: 45 CFR - Department of Health and Human Services 21 CFR - Food and Drug Administration 38 CFR - Department of Veterans Affairs
The common federal policy for protecting human subjects, promulgated in regulation and contained in the CFR, that outlines the provisions regarding the review and approval of research, is generally referred to as the “Common Rule”. It was signed by 17 federal agencies, including the VA, which are thus bound by it. The DHHS “Common Rule” is found at 45 CFR 46 Subpart A. Comparable regulations for the VA are found at 38 CFR 16 & for FDA are 21 CR 50 and 56.
VA Cooperative Study - A multi-center, centrally coordinated clinical trial funded by VA R&D Cooperative Studies Program (122). It is a program that allows for flexible proposal development by investigators supported by an extensive network of professional biostatisticians, health economists, pharmacists, programmers, and administrators. Multi-center studies require IRB and R&D approval at each site of the study. Website: www.vacsp.gov/flashindex.cfm
Food and Drug Administration - Regulates products, drugs, devices biologics and food/color additives (collectively known as FDA-regulated test articles). Regulates clinical investigations, defined as: Involves use of a test article One or more human subjects Has the authority to suspend clinical trials and/or disqualify clinical investigators not in compliance with FDA regulations. Website: www.fda.gov
Federal Wide Assurance - A formal agreement, which outlines an institution’s commitment to conduct its research projects in an ethically sound manner and to protect the welfare of the human subjects. Federal policy requires this for all institutions ‘engaged’ in federally supported human subjects research. [45 CFR 46, section 103(a)] This replaces the OHRP MPA (Multiple Project Assurance).
Human Research Protection Program - The systematic and comprehensive approach by an organization to ensure human subject protection in all research. The implementation of any part of the program may be delegated to specific committees, individuals or entities by the organization.
Institutional Animal Care and Use Committee - The local committee with a research program involving the use of live vertebrate animals, responsible for assuring compliance with animal research regulations and guidelines.
Investigational Device Exemption - A FDA requirement for any new device that is not commercially or generally available and is to be used in a clinical investigation. New medical products not yet been approved for marketing by the FDA require a special status so they can be legally shipped for the purpose of conducting clinical investigations to establish safety and efficacy. An approved investigational device exemption (IDE) permits a device to be shipped to conduct clinical investigations of that device. [21 CFR 812]
Investigational New Drug Application - A FDA requirement for any new drug, antibiotic drug or biological drug that is used in a clinical investigation. IND is an investigational new drug application and is synonymous with “Notice of Claimed Investigational Exemption for a New Drug,” given so the drug can be legally shipped. Investigational new drug (or investigational drug) means a new drug or biological drug used in a clinical investigation. An investigational drug must have an IND before it can be shipped. May also be required of an existing drug being evaluated for a new indication, dose or route of administration. [21 CFR 312]
A document that provides a summary of a medical or nono-medical research trial and explains to a potential subject their rights as a participant. Basic elements of Informed Consent [45 CFR Part 46.116a and 21 CFR Part 50.25a, 38 CFR 16.116a] Statement that the study involves research; explanation of purposes of the research and expected duration of subject’s participation; description of procedures to be followed and identification of any procedures which are experimental. Description of risks or discomforts to subjects. Description of benefits to subjects or to others. Disclosure of alternative procedures, if appropriate. Description of the extent to which confidentiality will be maintained. (FDA requires statement that they may inspect records.) Explanation of whom to contact if questions arise about: a) the research; b) the subject’s rights; or c) whom to contact if research related injury occurs. For research involving more than minimal risk, explanation as to whether compensation and medical treatments are available if injury occurs Statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits, and that subjects may discontinue at any time. Additional elements of Informed Consent (supplied when appropriate [45 CFR Part 46.116b and 21 CFR Part 50.25b, 38 CFR 16.116b] 1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. 2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. 3. Any additional costs to the subject that may result from participation in the research. 4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. 5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject 6. The approximate number of subjects involved in the study.
Institutional Review Board - A committee established by law that oversees all research involving human subjects at an institution. The IRB is legally viewed as the protector of integrity and ethical standards of all research and has the authority to enforce these standards. The main function of the IRB review are to assure that: Risks are minimized and are reasonable in relation to anticipated benefits. There is voluntary informed consent. Rights and welfare of subjects are protected. Membership must include at least: Five (5) members, of diverse backgrounds. One member not affiliated with the institution. One member whose primary concerns are in scientific areas. One member whose primary concerns are in nonscientific areas. The IRB has the authority to: approve, disprove or modify conduct continuing review observe/verify changes suspend or terminate approval The IRB’s determination is final! The institution or institutional officials cannot over rule. In the VA system, the IRB is the Human Subjects Subcommittee of the Research & Development Committee. (Note: The R&D cannot override disapproval from the IRB. A protocol must have approval from both the IRB and the R&D to be performed at a VA facility.) [38 CFR 16, 21 CFR 56; 45 CFR 46; VA Manual 3, Part 1, Chapter 9] Note: Often referred to as the Human Subjects Subcommittee to R&D Committee]
National Committee for Quality Assurance - The purpose of the program is to strengthen the protections afforded to human subjects participating in research at a VAMC through an ongoing independent, external review. The organization has been contracted by the Department of Veterans Affairs to develop and implement an accreditation program for all VAMC human research protection programs. Website: www.ncqa.org
National Institutes of Health - Agency within DHHS with both extramural and intramural research programs that provides funding for research, conducts studies and funds multi-site national studies. NIH is composed of many separate institutes dealing with specific health issues, i.e. aging, cancer, heart, etc. Website: www.nih.gov
Office of Human Research Protection - formerly OPRR -Office for Protection from Research Risk An administrative unit within the Department of Health and Human Services (DHHS). In June 1999, on recommendation of the advisory committee to the Director of NIH and acceptance by HHS Secretary Donna E. Shalala, OPRR was relocated in the Office of the Secretary to elevate its stature and effectiveness. The primary responsibility within the federal government is for developing and implementing the policies, procedures and regulations required to protect human subjects and animals involved in research sponsored by HHS. OHRP provides guidance to IRB members as well as scientists and research administrators on the complex ethical issues relating to the use of animals and human subjects in biomedical or behavioral research. OHRP also has a regulator role. They monitor and evaluate an institution’s compliance with the rules governing research subjects. Furthermore, they have the authority to investigate and, if necessary, to require corrective action or even suspend HHS funding to an institution until the problems are resolved. Website: www.hhs.gov/ohrp
Principal Investigator (also Clinical Investigator or Investigator) - Person who develops, submits to IRB/R&D, conducts and directs the study. Person who is ultimately responsible for the conduct of the study. In the VA system, the PI must have at least a 1/8 VA appointment.
Public Responsibility in Medicine and Research - A national nonprofit organization dedicated to educating the medical and legal professions, industry and the public about the ethical, legal and policy dimensions of appropriate and ethical research. IRB 101 is a comprehensive educational program that covers the fundamentals of relevant ethical principles, federal regulations, administrative procedures and other “best practices” that govern IRB operations. Website: www.primr.org
Research and Development Committee - Has the responsibility to follow the principles, objectives and functions outlined in the VHA Handbook 1200. The R&D Committee is responsible for maintaining high standards throughout the program. These standards include those assuring the scientific quality of research projects, protection of human subjects, safety of personnel engaged in research and animal welfare. Differs from an IRB in that it focuses more on the scientific peer review of protocols. But, no research may be undertaken without its review and approval. The IRB and IACUC are sub-committees of the R&D. (ie. Protocols must have IRB and R&D approval before they may begin.)
Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion. The Scientific Misconduct Policy for ETSU is located on the Responsible Conduct in Research website managed by the ETSU Office for Research and Sponsored Programs Administration.
Standard Operating Procedures
Detailed, written procedures for the uniform performance of a function. For example, IRB must have written SOP’s. These must be consistent with the “Common Rule” and federal regulations and policies pertaining to research compliance and protection of human subjects. (Federal regulations tell “what” to do, but not “how” to do it. individual institutions SOP outline the “how” to do research at that institution.)
Veterans Integrated Service Networks - VHA is divided into 22 networks that provide a structural and organizational foundation for integrating services and planning for the VA medical care system.
Last updated on December 23, 2005
Home Page / E-mail webmaster
© ETSU 2005