There are three categories of review for human subject applications:
All research proposals involving human subjects must be reviewed by the Institutional Review Board (IRB). If the research falls within one of the categories itemized below, the project may be determined to be exempt. Note that Title 45 CFR Part 46 (Subparts B-D) provides additional protection for several groups of research subjects.
Projects that qualify as exempt pose no risk to extremely minimal risk to participants.
Federal law specifically requires that an investigator, department chair, and/or other supervisor of an investigator may not make the final determination as to whether a project merits the exempt designation.
The IRB has assigned the ORSP to determine whether exempt status is warranted. At its discretion, the ORSP may choose to submit an exempt protocol to other IRB committee members for review.
Exempt projects still must be conducted in accordance with the general principles of human subjects protection.
Any proposed changes to the research need to be reviewed by the IRB.
Human subjects applications must be reviewed by the ORSP to confirm that they meet the criteria for exempt status. Once an application is received by the ORSP, it will take approximately 2-3 business days to review. The ORSP may send applications submitted as exempt to additional IRB committee members for further review. This review process will take approximately three weeks.
*Special note for research involving minors:
The IRB has determined that projects involving minors will not be reviewed using the exempt procedures.
Six categories qualifying proposals as exempt:
A) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
(1) Research on regular and special educational instructional strategies, or
(2) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
B) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(1) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(2) 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.
C) 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) of this section, if:
(1) The human subjects are elected or appointed public officials or candidates for public office; or
(2) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
D) 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.
E) Research and demonstration projects which are conducted by or subject to the approval of any federal department or agency heads and which are designed to study, evaluate, or otherwise examine:
(1) Public benefit or service programs;
(2) Procedures for obtaining benefits or services under those programs;
(3) Possible changes in or alternatives to those programs or procedures; or
(4) Possible changes in methods or levels of payment for benefits or services under those programs.
F) Taste and food quality evaluation and consumer-acceptance studies, (1) if wholesome foods without additives are consumed or (2) 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 FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
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Expedited review may apply to human subjects applications that do not meet the guidelines for exempt review. Research in this category must involve no more than minimal risk for participants.
According to the Office of Human Research Protections (OHRP), minimal risk "means that the probability and magnitude of harm or discomfort anticipated in the research are not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
OHRP guidelines also specify Categories of Research that Institutional Review Boards (IRB) may review through the expedited review process. In addition to the categories provided by OHRP, Loyola University Maryland's Policies and Procedures for Research Involving Human Participants indicate that all human subjects applications involving minors (individuals under 18 years of age) as participants are to be reviewed through the expedited review process.
When an expedited application is received by the ORSP, it is sent to two IRB committee members for review. The expedited review process will take approximately three weeks. The reviewers refer any research protocols that are not approved through the expedited process for a full review. The reviewers also may refer other research applications to the entire IRB whenever either of the reviewers believes that full review is necessary.
Annual review is required for expedited projects lasting longer than one year.
A protocol can be considered closed when:
All participant recruitment and enrollment is complete;
All records and data have been obtained;
No further contact with participants is necessary; and
- Analysis of participant identifiable data and records is complete or access to identifiable data is no longer necessary.
Waiver of Parental Consent for Minors: If an investigator requests a waiver of parental consent for a project involving minors, the application must be reviewed by a minimum of three members of the IRB.
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Human subjects applications scheduled for full review are distributed to all members of the Institutional Review Board (IRB) prior to the meeting, along with all relevant correspondence pertaining to the application. Additionally, the Principal Investigator will be invited to present the project to the committee. Consultants or experts also may be invited to the meeting to advise the IRB in its review of an application.
For a research application to be approved, the application must receive the approval of a majority of the IRB members present at the committee meeting.
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