Definitions & Terms

• Principal Investigator
  The Principal Investigator (PI) is the individual responsible and accountable for designing, conducting, and monitoring a protocol. The PI must be a suitably qualified member of the senior, junior, research, or adjunct staff, or a registered nurse, pharmacologist, psychologist or other health professional. Consultants and students may not serve as PIs on protocols. The PI assumes full responsibility for the treatment and evaluation of patients and the integrity of the research data. The PI must assure that the protocol is followed and the data collected promptly and accurately. The PI assumes specific responsibilities to include: writing the protocol document, assuring that necessary approvals are obtained, monitoring the protocol during its execution, and analyzing the results.

• Protomechanics - A Guide to Preparing and Conducting a Clinical Research Study
  An NIH Clinical Center publication designed to help guide investigators through the human subjects research review process, including protocol preparation, informed consent, initial review process, implementation, and ongoing annual review. Copies of this booklet are available online (http://www.cc.nih.gov/ccc/protomechanics/index.html) or from the NIEHS Clinical Director's office.

• FWA (Federal Wide Assurance)
  This newer assurance is gradually replacing the MPA and Single Project Assurances that formerly outlined institutional policies for protecting human participants (see below). The Federal Policy (Common Rule) for the protection of human subjects at Section 103(a) requires that each institution  engaged  in Federally-supported human subject research file an  Assurance  of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both  awardee  and collaborating  performance site  institutions. For more information, see OHRP IRB Registration and Assurances (http://www.hhs.gov/ohrp/) .

• MPA (Multiple Project Assurance)
  This assurance has been replaced by the newer FWA; however, the procedures outlined in the former MPA document are found at the NIH Office of Human Subject's Research Web pages under Information Sheets (http://www.nihtraining.com/ohsrsite/info/info.html) and Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health (http://www.nihtraining.com/ohsrsite/guidelines/GrayBooklet82404.pdf)  . The MPA embodies the NIH policies and procedures for protecting human subjects.

  The NIH MPA includes policies and procedures regarding:

  1. the responsibilities of intramural investigators who conduct, support or collaborate in basic or clinical research activities involving human subjects;
  2. the responsibilities of the NIH's IRBs for the review and approval of research activities involving human subjects; and
  3. the responsibilities of the NIH's Office of Human Subjects Research (OHSR) in protecting human subjects.

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• Research
  Any systematic investigation designed to develop or contribute to generalizable knowledge.

• Human Subjects
  A human subject is a living individual about whom an investigator obtains either:

  1. data through interaction or intervention with the individual, or
  2. identifiable private information.

• Research & Human Subjects
  Investigators at the NIH are responsible for protecting the rights and welfare of the human subjects who participate in their research. They must also understand the ethical standards and regulatory requirements governing their research activities. All intramural investigators who conduct or collaborate in a research activity are responsible for knowing whether or not their research involves human subjects. When it is not clear to an investigator whether research activities involve human subjects, he or she is encouraged to seek the advice of others, including Section, Laboratory and Branch Chiefs, and the IRB Chairperson.

• Specific Research Activities that do not Require IRB Review
  The collection and study of the following do not require IRB review:

  1. samples from deceased individuals;
  2. samples collected for diagnostic purposes only (as long as they are not used for research purposes);
  3. samples or data that are available from commercial or public repositories or registries;
  4. established cell lines that are publicly available to qualified scientific investigators, and
  5. self-sustaining, cell-free derivative preparations including viral isolates, cloned DNA, or RNA.

• Exempt Activities
  There are several categories of research that, although they involve human subjects, are exempt (http://www.nihtraining.com/ohsrsite/mpa/mpa.html) from IRB review. The general rationale behind the categories of exemption is that although the research involves human subjects, it does not expose them to physical, social or psychological risks.

  In essentially all of these studies one must record information only in such a manner that no human subject can be identified either directly or through identifiers linked to the individual.

  1. educational practices in an educational setting;
  2. educational testing;
  3. the collection of EXISTING data, documents or pathological specimens if these sources are publicly available or if the information is recorded by the investigator so that subjects cannot be identified directly or through identifiers linked to the subjects;
  4. taste and food quality testing

  If you have a study you think might be exempt, you must check it out in advance of any action with your IRB Chair. Investigators should not make determinations about exemptions without consulting their IRB Chair, who will in turn consult with the NIH OHSR.

  Ask your IRB Chair for the form to officially request an exemption.

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• Minimal Risk
  Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Special guidelines are applied to research involving children (http://ohsr.od.nih.gov/info/sheet10.html) .

• Expedited Review
  Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories may be reviewed by the IRB through the Expedited Review Process.

  1. Collection of hair and nail clippings, in a nondisfiguring manner, deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
  2. Collection of excreta and external secretions, including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membranes prior to or during labor.
  3. Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. These includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter of significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
  4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an 8-week period and no more often than 2 times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
  5. Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
  6. Voice recordings made for research purposes such as investigations of speech defects.
  7. Moderate exercise by healthy volunteers.
  8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
  9. Research on individual or group behavior or characteristics of individuals, such as studies or perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to the subjects.
  10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

For new protocols, expedited review can be requested by the PI in a written memo attached to the Initial Review Application (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/1195.pdf)   (673K) (http://www.niehs.nih.gov/about/orstructure/boards/irb/docs/1195.pdf) and protocol. It is applicable only to studies of minimal risk.

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