Institutional Review Board

Review Process

 

Federal Guidelines
For Federal regulations governing human subject research, go to the Health and Human Services website.

In accordance with the University’s Assurance Agreement, when appropriate, the following will be reported to institutional officials, the federal Office of Human Research Protections, and/or other governmental agencies: any unanticipated problems involving risks to subjects or others; serious or continuing non-compliance with pertinent federal regulations or the requirements of the IRB; and suspension or termination of IRB approval of research protocols.

Non-compliance with IRB requirements will result in withdrawal of IRB approval and in the suspension or termination of the research.

Federal regulations require that all applications submitted to the IRB be screened to determine if the research is exempt from or requires a review. It is the IRB, not the researcher, that makes this decision.  Accordingly, all applications are initially reviewed by a subcommittee of members of the IRB to determine whether a proposal will be considered under exempt, expedited or full Board review. The results of this initial review are announced at the first subsequent meeting of the full Board. Any member of the IRB, however, may ask that a proposal be given the consideration of the entire Board. In this event, the decision of the initial review is superseded by the decision of the full Board. The Board’s decision is then recorded in the minutes.

A. Exempt

Federal regulations indicate the following research activities are exempt:

  1. Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.

  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing or employability.

  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures or observation of public behavior that is exempt under paragraph (2), if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statue(s) requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

  4. Taste and food quality evaluation studies, if wholesome foods without chemical additive are consumed or if a limited amount of a food is consumed that contains a food additive or agricultural chemical at or below a level approved by the Food and Drug Administration, the Environmental Protection Agency, or the Animal Plant Health Inspection Service of the United States Department of Agriculture.

  5. Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the observations recorded about the individual, if they become known outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability, and (iii) the research deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.

  6. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject.

B. Expedited Review

It is possible for the IRB to review through expedited procedures certain categories of research which recur with some regularity. They include:

  1. Collection of: hair and nail clippings, in a non-disfiguring 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 membrane 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. This 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 or significant amounts of energy into the subject or an invasion of the subjects privacy. This 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 eight-week period and no more often than two 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 of healthy volunteers.

  8. The study of restricted access data, documents, records, pathological specimens, or diagnostic specimens.

  9. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the research investigator does not manipulate subject’s behavior and the research will not involve stress to subjects.

  10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

  11. Any other category specifically added to this list by HHS and published in the Federal Register.

C. Full Committee Review

All other projects not described as exempt or expedited will require full Committee review.

Continuing Review (See also guidelines on the Health and Human Services website.)

Protocols will undergo the federally mandated continuing review no later than 12 months after initial approval has been granted. If risks to subjects are regarded as extraordinary, re-review at more frequent intervals may be required.  Please notice that after one year, the proposal is no longer valid and needs to go through such review.  An IRB continuing review form needs to be filled out and sent in to the IRB office within 30 days before the existing approval expires.  The IRB office will send a letter and the continuing review form within 30 days prior the deadline.  The researchers can also download the continuing review form, fill it out and mail/e-mail it to the office (irb@shu.edu) so that it gets to the office before the IRB approval expires.

Contact Us

Institutional Review Board
(973) 313-6314
Fax (973) 275-2361
irb@shu.edu
Presidents Hall Rm. 325

 
 

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