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ETSU Research Links
Clinical Trials Information
Ethical Conduct of Research
45 CFR 46 - HHS Protection of Human Subjects
21 CFR Part 50 - FDA Protection of Human Subjects
21 CFR Part 54 - Financial Disclosure by Clinical Investigators
21 CFR Part 56 - Institutional Review Boards
21 CFR Part 312 - Investigational New Drug Application
21 CFR Part 314 - Applications for FDA Approval to Market a New Drug
21 CFR Part 812 - Investigational Device Exemptions
38 CFR Part 16 - Pensions, Bonuses, and Veterans' Relief
21 CFR Part 11 - Inspections, Compliance, Enforcement, and Criminal Investigations
AAALAC: 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
AAMC: 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
Belmont Report: 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
CFR: 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.
Common Rule: 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.
FDA: Food and Drug Administration - Regulates products, drugs, devices biologics and food/color additives (collectively known as FDA-regulated test articles). Regulates clinical investigations. Website: www.fda.gov
FWA: Federal Wide Assurance - A formal agreement, which outlines an institutions 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)]
HRPP: 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.
Human Subject: A living individual about whom an investigator (whether professional of student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens [FDA regulations define human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject might be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used.]
IACUC: 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.
IDE: 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]
IND: 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]
Informed Consent: A document that provides a summary of a medical or non-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 subjects 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:
- the research
- the subjects rights; or
- 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.
- For studies subject to the 2018 Common Rule, A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be a possibility; or a statement that the participant's information or specimens collected as part of research, even if identifiers are removed, will not be used or distributed for future research studies.
- Additional elements of Informed Consent (supplied when appropriate [45 CFR Part 46.116b
and 21 CFR Part 50.25b, 38 CFR 16.116b]
- 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.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- 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
- The approximate number of subjects involved in the study.
- For studies subject to the 2018 Common Rule, a statement that biospecimens, even if identifiers are removed, may be used for commercial profit and whether the participant will or will not share in this commercial profit UNLESS the study does not involve the collection of biospecimens
- For studies subject to the 2018 Common Rule, a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions UNLESS there will be no clinically relevant research results.
- For studies subject to the 2018 Common Rule, a statement about whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) UNLESS the study does not involve the collection of biospecimens OR the study will not include any whole genome sequencing
IRB: 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 functions 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.
The IRBs 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] Often referred to as the Human Subjects Subcommittee to R&D Committee.
NIH: 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
OHRP: Office of Human Research Protection. An administrative unit within the Department of Health and Human Services (DHHS). 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 institutions 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
PI: 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.
PRIM&R: 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. Website: www.primr.org
R&D: 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. No VA research may be undertaken without its review and approval. The IRB and IACUC are sub-committees of the R&D. (i.e. Protocols must have IRB and R&D approval before they may begin.)
Research: 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]
Research Misconduct: 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.