IRB Application Review Process & Procedures
If your project involves research and human subjects as defined by 45 CFR 46, you must submit an application to the IRB for approval prior to the recruitment of subjects and the collection of data.
Human subject research for student theses and dissertations always requires prior IRB approval. Once a project is determined to fall under the purview of the Widener University IRB, one of three levels of review are possible. The chair of the IRB committee determines the category of review.
The three levels of review for studies involving human subjects are as follows: Exempt, Expedited Review, and Full Review.
Basic Definitions Related to Research
Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Note: In many cases, the determination of whether a particular research activity involves human subjects is not difficult, but in some cases, the line is blurred. When it is not clear to an investigator whether research activities involve human subjects, he or she is encouraged to seek the advice of others, which can include the IRB members or chairperson. In questionable cases, final responsibility for determining whether human subjects are involved rests with the IRB
IRB Approval: the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
Minimal Risk: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Research: systematic investigation designed to develop or contribute to generalizable knowledge.
Research Review Categories
Research falling into this category is based on the determination that the human subject research in question meets the federal requirements to waive IRB review.
The exempt category does not mean that the application is not reviewed by the IRB. Exempt applications will receive a review by the IRB chairperson and by at least one other committee member. At the chair’s discretion, a representative of the IRB may take the place of the chair on exempt and expedited reviews. Both reviewers must be in agreement for approval of the protocol. Should there be a split vote, the proposal will move to a full committee review.
The proposal may not require written documentation of informed consent. However, oral consent is required for all interactions with human subjects. Research conducted in a school setting may require the written approval of the school district.
For proposals that do not receive either approval or conditional approval from the reviewers, the principle investigator can request a full review by the IRB committee.
Examples of Exempt Research
- 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 or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, and achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (b) 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.
This exemption category for research involving survey or interview procedures or observation of public behavior does not apply to research with children, except for research involving observations of public behavior when the investigator(s) does not participate in the activities being observed.
- Research involving the collection or study of existing data, documents, records, pathological 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.
- All research using survey or interview procedures is exempt when the respondents are elected or appointed public officials or candidates for public office.
- Secondary analysis of existing data.
- Anonymous mail, web-based research, or telephone surveys on innocuous topics.
- Research on individual or group behavior of non-disabled adults where there is no psychological intervention, physiological intervention, or deception.
- Research used for program evaluation, and demonstration projects which are conducted by or subject to the approval of department chair, dean, or academic vice president, and which are designed to study , evaluate, or otherwise examine: (i) public benefit of 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 an 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.
II. Expedited Review
Expedited review means that the research in question can be reviewed and approved by one or more members of the IRB because it meets the criteria listed in 45 CFR 46 and 45 CFR 46.110.
Research protocols considered for expedited review pose a minimal risk to the participants. Previously approved research protocols with minor changes can also receive an expedited review.
Protocols will be reviewed by a minimum of two reviewers and the IRB chairperson. Reviewers are assigned by the IRB committee chairperson. Agreement of all reviewers is required for approval. In the event the vote on a research application is not unanimous, the proposal will move to a full committee review. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.
The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
Examples of research protocols receiving expedited review
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312.2) is not required.
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared or approved for marketing. Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
III. Full Review
For all research involving human subjects that carries more than minimal risk, informed consent is necessary. Research is reviewed by the full IRB if it does not fall under one of the above categories, and (usually) if it involves minors, the cognitively impaired, prisoners, pregnant women, fetuses, or the educationally/economically disadvantaged. Sensitive research topics may also require full review.
- Research which poses more than minimal risk.
- Research involving psychological or physiological interventions.
- Non-curricular interactive research in any school setting.
- Research involving deception which might have an adverse physiological or psychological effects on the participants.
- Research involving any special population – minors, prisoners, individuals who are cognitively impaired or disabled.
Guidance in Picking a Review Category
Human Subject Regulations Decision Tree This link will help you to determine if your research requires review by the IRB based on principles contained in Title 45 CFR Part 46. The Office for Protection from Research Risks (OPRR) provides the associated graphic aids to clarify portions of the Department of Health and Human Services (DHHS) human subject regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46).
A simple majority vote from the voting members of the IRB is required on any application receiving a full committee review. The number of members voting for or against a proposal or abstaining is recorded by the secretary.
Any IRB member having an interest in any protocol being reviewed by the committee cannot participate in the review or vote.
After reviewing the application, there are five possible outcomes:
- Approved as submitted – data collection can begin upon receipt of the letter from the IRB chair informing the researchers of the committee’s decision.
- Approved pending changes to proposal with follow-up review by the IRB committee chair – data collection can only begin after the required revisions are made to the study proposal, research protocol, or consent form. If the decision of the IRB is to approve with changes to effect approval, the comments are sent to the investigator. The investigator has 60 days to respond to the committee’s request for changes. After 60 days, the application will be administratively terminated.
- Conditionally approved, changes to be reviewed by the full IRB – data collection can only begin after the required revisions are made to the study application, research protocol, or consent form. If a study is conditionally approved it is because the IRB has requested new information or justification of some aspect of the study rather than just changes that the board has directed the investigator to make. In this case, the requested changes or new information will be reviewed by the IRB at a convened meeting.
- Not Approved – substantive changes are required and with revision, the application can be resubmitted for a review by the full IRB committee at a later date. If a study is not approved as submitted, a letter will be sent to the investigator with the reasons for the disapproval. A non-approval indicates considerable issues with the design of the study and/or with the construction of the consent form which prevent the study from being approved in any manner. The investigator may resubmit the study to the IRB as a new full submission after addressing the concerns of the IRB.
- Suspension or termination of a previously approved study.