The IRB will conduct a review of submitted proposals to determine if:
- Risks to participants are minimized by using appropriate procedures.
- Risks are reasonable in view of anticipated benefits of the research.
- Selection of participants is equitable. Justification is required if the participant population is restricted to one gender or ethnic group.
- Adequate provision is made for confidentiality of data and anonymity of each participant in any disseminated venue.
- Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically, or educationally disadvantaged.
- Adequate provision is made for obtaining informed consent of the participants, including those for whom English is not their first language. In the latter case, informed consent should be obtained in the participant's native language.
Definitions of Types of Risk
Physical risk includes physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research.
Psychological effects may be experienced during the research situation and/or later, as a result of participating in the research. Psychological risk includes anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, or loss of self-esteem.
Social risk includes alterations in relationships with others that are to the disadvantage of the participant, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the participant's opportunities and powers in relation to others.
Legal risk of criminal prosecution or civil lawsuit can occur when research methods reveal that the participant has or will engage in conduct for which the participant or others may be criminally or civilly liable.
Exceptions to Review (No Application Required)
Only scholarly activity that meets the definition of “research” with human participants in the Federal regulations is required to be submitted for IRB review. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Examples of activities that do not qualify as research for purposes of IRB review include: oral history, journalism, biography, literary criticism, legal research, and historical scholarship, including the collection and use of information that focus directly on the specific individuals about whom the information is collected. Similarly, data collection for self-limited quality-control purposes are excluded from review.
For classroom-initiated projects that may not be required to be 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:
- Developing an awareness of the types of risk participants may be exposed to in various types of research projects (i.e., physical, psychological, social, and legal).
- Obtaining voluntary informed consent to participate in a way that honestly informs participants of the purpose and potential risks and benefits of the research.
- Managing potential risks to participants.
- Conducting a risk/benefit analysis for all populations, with special consideration given to vulnerable populations (e.g., children, developmentally disabled).
- Protection of anonymity/confidentiality of the participants.
Three Types of IRB Reviews
Research activities in which the only involvement of human participants will be in one or more of the following categories will qualify for review under the exempt category.
If applicable, please check the exempt category on your application form.
NOTE: Research projects that may qualify as "exempt" are still required to be reviewed and approved by the IRB. This category is different to the preceding section Exceptions to review (No application required).
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.
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 participant or an invasion of the participant'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 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 either the Exempt or Minimal Risk categories.
Application Approval and Continuing Review
Once a project is approved by the IRB, the Principle Investigator will be notified via email. Unless otherwise specified in the approval letter, Exempt projects will be approved for a period of 5 years. All other projects will be approved for a period of 1 year. Projects lasting longer than the approval period must submit for continuing review prior to the approval’s expiration.
If your research does not fit into any of the previous categories because the potential risk to the participants is more than minimal, check the Full Board category on your application form.