The IRB office first conducts an administrative review for completeness of the application. The IRB Staff can request additional information about the research and/or request modifications to the application form, protocol, and/or informed consent documents prior to review by a member of the IRB. The IRB Staff also makes recommendations to the Chair and IRB members about the level of review a given project should undergo.
The IRB cannot issue retroactive approval for human subjects research activities conducted prior to IRB review and approval.
FULL BOARD REVIEW. Studies that are greater than minimal risk or include procedures that do not fit into one or more categories of expedited review must undergo review by the convened IRB (also referred to as the "Full Board"). Other studies that might undergo full board review include research in which incarcerated persons will be participants, research involving cognitively-impaired individuals or other highly vulnerable populations, or collection of research data that is highly sensitive. The convened IRB meets once per month. The convened IRB generally does not meet during the summer months.
EXPEDITED REVIEW. To qualify for expedited review, the research must be minimal risk and all of the research procedures must fall within one or more of the expedited review categories. For a listing of the expedited review categories, see http://www.hhs.gov/ohrp/policy/expedited98.html.
Review of expedited protocols (in which no additional information or modifications are required) takes 10-14 working days on average.
EXEMPT DETERMINATION. Under certain circumstances, human subjects research activities may be granted exempt status. To qualify for exempt status, the research must be no more than minimal risk and the research procedures must fall within the six exemption categories set out at 45 CFR 46.101(b). The exemption categories are:
- Research conducted in established or commonly accepted educational settings, involving normal educational 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.
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 or 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, employability, or reputation.
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 (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- 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 subjects.
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.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Research projects that qualify for an exemption are not subject to continuing IRB oversight -- therefore, exempt projects are not assigned an expiration date and do not undergo continuing review by the IRB. Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct.
The exempt categories apply to research involving pregnant women and fetuses. The exempt categories apply, with some limitations, to research involving children. Studies in which prisoners will be research participants do not qualify for exemption.
University policy does not allow investigators to self-exempt their human subjects research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB. It is estimated that reviews for exempt research typically take 5-7 working days.
Further, because research projects that qualify for an exemption are still "human subjects research" as defined in the federal regulations, the principal investigator and key personnel need to have taken human subjects protection training before beginning an exempt study.
Approval period. Once the IRB has reviewed the application, the researcher will be notified via AURA of the IRB's decision. For studies approved via expedited review or full committee review, IRB approval is valid only until the expiration date. Exempt projects do not have an expiration date. All research projects approved via expedited review or full committee review must be reviewed by the IRB no less than once a year. The approval period is determined by the IRB and is based on the type and degree of risk involved in the research.
Criteria for IRB approval. In order for the IRB to approve a research project, it must make the following determinations:
- Risks to subjects are minimized: (i) by using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits (if any) to subjects, and the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable. In making this assessment, the IRB takes into account the purposes of the research and the setting in which the research will be conducted and is cognizant of the special challenges of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative to the extent required by 45 CFR 46.116 (or the researcher has requested a waiver of consent and documented the reasons that justify a waiver).
- Informed consent will be appropriately documented to the extent required by 45 CFR 46.117.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, appropriate safeguards have been included in the study to protect the rights and welfare of these subjects.