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ETSU Research Links

Regional Health  

Additional Regulations

HIPAA

Mental Health

Oral History

Miscellaneous Links

Special Populations

   Prisoners Involved with Research

Accreditation Standards

    Association on Accreditation of Human Research Protection Programs (AAHRPP) Standards  

Clinical Trials Information

   Good Clinical Practice in FDA-Regulated Clinical Trials

    Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)

   FDA Clinical Trials Information for Consumer  

Ethical Conduct of Research

   The Belmont Report

   Declaration of Helsinki

   Geneva Physicians Oath

   ICH Code

   Nuremberg Code  

Guidance Statements

   FDA Information Sheets

   Human Subject Regulation Decision Charts

   OHRP IRB Guidebook

   OHRP Guidance by Topic      

Regulatory Guidance

   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  

 

 

Glossary

AAALAC: Association for Assessment and Accreditation of Laboratory Animal Care, International
AAAMC: Association of American Medical Colleges
Belmont Report
CFR: Code of Federal Regulations
Common Rule
FDA: Food and Drug Administration
FWA: Federal Wide Assurance
HRPP: Human Research Protection Program
Human Subject
IACUC: Institutional Animal Care and Use Committee
IDE: Investigational Device Exemption
IND: Investigational New Drug Application
Informed Consent
IRB: Institutional Review Board
NIH: National Institutes of Health
OHRP: Office of Human Research Protection
PI: Principal Investigator
PRIM&R: Public Responsibility in Medicine and Research
R&D: Research and Development Committee
Research
Research Misconduct

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 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)] 

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… 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]

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 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:
    • the research
    • the subject’s 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.
  • 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.

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 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]  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 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

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.[1] 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.  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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