Review Criteria

General Review Criteria

All research involving human participants (i.e., exploratory, descriptive, and experimental) must be reviewed by the IRB. If the proposed study has not been completely designed at the time a research proposal is submitted to a sponsor, provisional approval may be granted. Final approval must be sought when the research plans are complete and before the involvement of human participants in the project.

The reviewers will determine that:

1. Participation of human participants in the project is appropriate.
2. Risks to participants are minimized by using appropriate procedures.
3. Risks are reasonable in view of anticipated benefits.
4. Selection of participants is equitable. Justification is required if the subject population is restricted to one gender or ethnic group.
5. dequate provision is made for confidentiality of data and anonymity of each participant in any published record.
6. Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically, or educationally disadvantaged. Projects that have such populations are advised to contact an IRB member for further documentation.
7. Adequate provision is made for obtaining informed consent of the participants, including those for whom English is not their first language.

Definitions of Types of Risk

Physical Risk

Physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research.

Psychological Risk

Psychological effects may be experienced during the research situation and/or later, as a result of participating. Includes anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, altered behavior.

Social/Economic Risk

Alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and powers in relation to others. Economic risks include payment by participants for procedures, loss of wages or income, and damage to employability.

Legal Risk

Risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally or civilly liable.

Loss of Confidentiality

Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks include invasion of privacy, as well as the social, economic and legal risks outlined above.

Exceptions to Review (No Application Required)

Classroom curriculum projects, workshop evaluations, and administrative review projects need not be reviewed by the IRB if they are not research, results will not be distributed outside the classroom and/or institutional setting, or are used to evaluate or review a program in order to build a better program.

If, however, the results of the project will be published or otherwise distributed, in any form of media, the project must be reviewed by the IRB. If in doubt, it is wise to have the project reviewed. The Committee is unable to give post facto approval.

Even though some classroom initiated research is not reviewed by the IRB, it is important that instructors and students discuss the guidelines and ethics for protection of research participants and incorporate these into their methodology. Particular emphasis should be placed on:

1. Developing an awareness of the types of risk participants may be exposed to in various types of research projects, i.e., psychological, social, physical, economic, and legal.
2. Obtaining voluntary informed consent to participate in a way that honestly informs participants of the purpose and potential risks and benefits of the research.
3. Management of potential risks to participants.
4. A risk/benefit analysis for all populations, with special consideration of vulnerable populations (children, pregnant women, fetuses, mentally disabled, institutionalized persons, prisoners, etc.)
5. Protection of privacy and confidentiality of the participants.
6. Identification of benefit to be derived from participation in the research.

Exempt Review

Certain categories of research are exempt from full-board review. Exempt proposals are reviewed by only a few members of the IRB. The IRB chair sends a copy of the application to another member and both confer as to whether the project is exempt. If so determined, the Chair notifies the researcher that the project may proceed. The Chair might also request additional information before granting approval to proceed or may grant conditional approval relative to implementation of recommendation(s).

Research activities in which the only involvement of human participants will be in one or more of the following six categories will qualify for review under the exempt category.

If your research fits into one or more of these categories, check the exempt category on your application form.

Educational Setting

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

Educational Testing or Information Gathering Without Identification

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 participants can be identified, directly or through identifiers linked to the participants; and (ii) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.

Educational Testing or Information Gathering With Identification

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph (2) of this section, if: (a) The human participants are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Collection of Existing Information Without Disclosure

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 participants cannot be identified, directly or through identifiers linked to the participants.

Evaluation of Public Benefit Programs

Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Investigation of Consumer Products

Taste and food quality evaluation and consumer acceptance studies (a) if wholesome foods without additives are consumed; or (b) if a food is consumed that contains a food ingredient at or below the level, and for a use, found to be safe; or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Minimal Risk Review

Research activities involving no more than minimal risk and in which the only human participant involvement will be in one or more of the ten categories listed below, may be reviewed through the Minimal Risk review procedure. Such reviews do not require discussion by the full IRB Committee. The chairperson of the IRB chooses a limited number of committee members to review the proposal by e-mail. The IRB members return their comments to the chair, who notifies the principal investigator of the results of the review.

If your research fits into one or more of the Federal Guideline categories below, check the minimal risk category on your application form.

Collection of Non-disfiguring Body Parts

Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.

Collection of Body Secretions

Collection of excreta and external secretions including sweat, saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.

Data Collection Using Non-Invasive Procedures & From Participants 18 Years of Age or Older

Recording of data from participants 18 years of age or older using noninvasive procedures routinely employed at 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 subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiograph, 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).

Collection of Blood From Participants 18 Years of Age or Older

Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more than two times per week, from participants 18 years of age or older and who are in good health and not pregnant. Please refer to the Appendix, Collection of Body Fluids.

Collection of Dental Material

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.

Voice Recordings

Voice recordings made for research purposes such as investigations of speech defects.

Moderate Exercise of Healthy Participants

Moderate exercise by healthy volunteers.

Collection of Existing Medical Data, Pathological or Diagnostic Specimens

The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

Conducting Behavioral Studies without Subject Manipulation

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

Research Which Does Not Involve New Drugs or Devises

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

Full Board Review

All members of the IRB committee will review all proposals which do not fall into the Exempt or Minimal Risk categories.

Continuing Review

In its initial review of a proposal, the IRB will consider the extent of continuing review needed for research projects that are likely to continue for more than one year. All proposals shall be reviewed annually, but in certain research the participants are exposed to more than usual risk; such proposals will be reviewed at more frequent intervals appropriate to the research. This review interval will be determined at the time the research is approved and may be changed at the discretion of the IRB. In each such review, the principal investigator will be required to promptly report the status of the research activity, and any proposed changes in the research activity. If the research is still in progress, the investigator will affirm that the approved research protocol involving human participants is being followed.