IRB Levels of Review
The Code of Federal Regulations, Title 45, Part 46.102, Section d, defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. As is common practice among college and university based IRBs, however, the IRB also extends some level of ethical oversight to class based student research projects not designed to contribute to generalizable knowledge (see section A, point 2 below). In compliance with Part 46.102, Section f of the Federal Regulations, a human subject is defined as “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. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment for research purposes. Interaction includes communication or interpersonal contact between investigator and subject”. Identifiable private information involves behavior displayed or information provided in a context the subject could reasonably expect would not be made public but which the investigator can readily link to the individual.
Exempt from Review
The following are exempt from IRB review. For cases (1) through (4) below, exempt status is automatic and investigators do not need to seek IRB approval. However, for cases (5) and (6), the determination of exempt status is not relegated to the investigator. It must be determined by a department representative or by the Executive Committee. In these latter cases, the investigator must submit an Application for Exempt Status to their department representative. In cases for which the appropriate department representative is unclear, the investigator should contact the IRB chair for guidance.
The research is eligible for automatic exemption if –
- it does not involve human subjects.
- it is a faculty-supervised, class-based project designed solely to enhance the educational experience of the students (See Note 1 below) and all of the following criteria are met:
- Project findings will not be shared with the research subjects unless they also are members of the class in which the project originated.
- Project findings will not be presented in any public forum outside the class in which the project originated.
- The procedures and materials in the project put research subjects at no more than minimal risk for physical or psychological harm ordinarily encountered in daily life.
- The project does not involve the collection of sensitive aspects of subjects’ behavior, such as substance use, illegal conduct, or sexual behavior that can be linked through identifiers to any specific subjects.
- The project is not intended to satisfy the thesis requirements of a department’s capstone course.
- Prior to the collection of data, the class instructor has submitted to the IRB a Training Declaration attesting to his/her completion of the IRB training requirements for department representatives (see Note 1 below).
- Prior to the collection of data, the class instructor also has submitted to the IRB an Ethics Assurance Form indicating he/she will instruct the students in in the principles of ethical research and insure their projects conform to these principles (see Note 2 below).
- the human subjects are elected or appointed public officials or candidates for public office (Code of Federal Regulations, Title 45, Part 46.101, Section b-3).
- it examines “(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” (Code of Federal Regulations, Title 45, Part 46.101, section b-5). Furthermore, it must comply with the following OPRR guidelines for exempting such research:
- The program under study must deliver a public benefit or service.
- There must be no statutory requirement that the project be reviewed by an IRB.
- The research must not involve significant physical invasions or intrusions upon the privacy of subjects.
The research is eligible for IRB approved exemption if –
- its principal investigator is a member of the St. Joseph's University faculty, administration, or staff; no students, faculty, administration, or staff are employed as research subjects; no facilities are utilized for the research protocol; and it has been approved by an external IRB acceptable to the Executive Committee of the IRB. The investigator must submit appropriate documentation of the external approval to the Executive Committee prior to data collection.
- the research is conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (Code of Federal Regulations, § 46.10, Section d-1)
- the research only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation. (Code of Federal Regulations, § 46.10, Section d-2)
Note 1 – Faculty-supervised, class-based projects which fail to meet all the above criteria must be submitted for review to a department representative using either an Application for Exempt Status or an Application for IRB Expedited Review. If appropriate, an Application for Full IRB Review must be submitted to the IRB Chair.
Note 2 – Training Declarations and Ethics Assurance Forms for class instructors are held to be in effect for a period of three years from their dates of submission. Both can be renewed for additional three year terms through resubmission.
Normally, within seven days of receiving an Application for Exempt Status, the department representative must notify the principal investigator by email of its disposition. The following three dispositions are possible:
- Disposed as Exempt – The project meets the criteria for exempt status and can proceed as described.
- Approved Pending Revision – The project fails to meet the criteria for exempt status but with revision can be approved. The representative must specify the changes required. If the investigator makes the required changes and submits an amended Application for Exempt Status, the amended project can proceed as described.|
- Denied – The project fails to meet the criteria for exempt status, but cannot be readily revised. The representative must specify the reasons for denial and recommend either an expedited or full review. The investigator then can seek an expedited or full review of the project by submitting an appropriate application.
Research that does not meet the criteria for exempt status may be eligible for expedited review and approval by a department representative if it meets all the following criteria. The investigator must submit an Application for IRB Expedited Review to his/her department representative. In cases for which the appropriate department representative is unclear, the investigator should contact the IRB chair for guidance.
The research is eligible for expedited review if –
- it does not intentionally include members of at-risk populations such as children under 18 years of age (except as described for exempt educational research in Section A, Part 4), cognitively or emotionally compromised adults, pregnant women, fetuses, or prisoners as subjects.
- it does not involve the collection of sensitive data on substance use, illegal conduct, or sexual behavior that can be linked through identifiers to specific subjects; and which, if known by others, could reasonably place subjects at risk for criminal or civil liability, or damage their financial standing, employability, or reputation.
- it employs procedures and materials which put subjects at no more than minimal risk for physical or psychological harm ordinarily encountered in daily life.
- it does not require a waiver from informed consent provisions (see Note 3 below)
- it does not involve deception by commission in which subjects are deliberately misled by the investigator as to the purposes or procedures of the study.
Examples of deception by commission:
- To simulate real life conditions, subjects in a study investigating how job applicants respond to different interview techniques are told they are competing for actual job openings when none exist,
- The study involves audiotaping or videotaping subjects’ interactions with racially diverse confederates without their prior consent.
- any use of deception by omission, in which the investigator fails to disclose all relevant details of the study’s purposes or procedures, is scientifically justified and debriefing procedures are detailed and appropriate. The researcher must include in the application explanations for why full disclosure would invalidate the study’s results and why alternative non-deceptive procedures would not be appropriate. The researcher also must include a detailed description of how and when subjects will be debriefed as to the nature of the information withheld and the reasons for the omission.
Example of deception by omission:
- Subjects are told in general terms they will complete some paper-and-pencil tests assessing possible relationships between several personality traits but are not provided with specifics as to which traits will be measured or what relationships are expected.
- it does not involve audio taping, videotaping, or photographing of subjects.
Note 3 – A written and signed informed consent is normally required for all human subjects unless all the following conditions are met –
- the research poses no more than minimal risk for physical or psychological harm,
- all subjects are 18 years of age or older,
- the research does not involve audiotaping, videotaping or photographic subjects, and
- the written informed consent is the only identifier linking specific subjects to their data.
With the above conditions, subjects’ participation in the research protocol can be deemed as implied consent. If the research does not meet all of these conditions, however, a waiver from informed consent provisions can only be obtained through full review by the Executive Committee. (See the required elements for informed consent at the Informed Consent Provisions link) and samples of informed consent documents at either Sample Informed Consent for Students Investigators or Sample Informed Consent for Non-Student Investigators links.
Normally, within seven days of receiving an Application for IRB Expedited Review, the department representative must notify the principal investigator by email of its disposition. The following three dispositions are possible:
- Approved – The research protocol meets all criteria for expedited review and meets the ethical standards for research with human subjects. Applications approved by a department representative are deemed approved by the IRB. The investigator may proceed with data collection. It is expected that most applications will fall into this category. Please note that IRB approval is limited to a term of one year. Any project extending beyond that term must submit to the IRB an Application for Continuation indicating there has been no material changes in the research protocol.
- Approved Pending Revision – The research protocol fails to meet the criteria for expedited review and/or fails to meet the ethical standards of research with human subjects. However, with revisions, the protocol can be approved. The representative must specify the changes required for approval. If the investigator makes the required changes and submits an amended Application for IRB Review, he/she can proceed with the amended protocol upon approval from the representative. If the investigator rejects the required changes, he/she can request the representative to forward the application to the Executive Committee for a full review and attach a written justification for its approval as submitted. The investigator also must complete Section 4 of the Application for IRB Review required for full review.
- Deemed in Need of Full Review – The research protocol fails to meet the criteria for expedited review and the department representative determines a full IRB review is warranted. The investigator must complete and submit an Application for Full IRB Review.
There are three avenues by which an IRB Application must proceed to the Executive Committee for a full review:
- The principal investigator is unaffiliated with St. Joseph's University.
- An St. Josephs' College-affiliated principal investigator deems his/her research does not meet the criteria for exempt status or for expedited review.
- An St. Joseph's University-affiliated principal investigator submits his/her application for expedited review, but the department representative determines it fails to meet the relevant criteria and must be forwarded for full review. In such cases, it is incumbent on the investigator to then complete section 4 of the application and attach a detailed description of the research protocol as specified in the application material before it is forwarded. The department representative, at his/her discretion, may also forward his/her recommendation with justifications to approve, approve pending revision or deny the investigator’s application.
In all the above cases, the investigator must submit an Application for Full IRB Review and all supporting documents to the IRB chair at least one week prior to a scheduled full review meeting. In addition to two scheduled meetings per semester, the IRB chair has the authority to schedule additional full review meetings when the need arises. To render a decision, a quorum of four Committee members, including the community representative(s), must be present at the full review meeting and be sufficiently informed about the application. In addition, the Committee reserves the right to solicit input from individuals having specialized knowledge when reviewing proposed research for which its members lack sufficient expertise. If the committee cannot achieve a consensus decision, the majority opinion determined by ballot prevails. If no majority emerges, the more ethically conservative opinion prevails.
Normally, within three days of the full review meeting, a designated committee member must notify the principal investigator by email of the application’s disposition, including, when applicable, the committee’s reasons for requiring revision of, or denying, the application. The following three dispositions are possible:
- Approved – The research protocol meets all ethical standards for research with human subjects. The investigator may proceed with data collection. Please note that IRB approval is limited to a term of one year. Any project extending beyond that term must submit to the IRB an Application for Continuation, indicating there have been no material changes in the research protocol.
- Approved Pending Revision – The research protocol fails to meet all ethical standards for research with human subjects. However, with revisions, the protocol can be approved. The committee must specify the changes required for approval. If the investigator makes the required changes and submits an amended Application for IRB Review, he/she can proceed with the amended protocol upon approval from the Executive Committee. If the investigator rejects the required changes, he/she can appeal the IRB decision (see link for Appealing Adverse IRB Dispositions).
- Denied – The research protocol fails to meet all ethical standards for research with human subjects and cannot be readily revised to attain those standards. The committee must specify the reasons for denial and stress the proposed research cannot proceed. If the investigator believes the IRB decision is in error, he/she can appeal the IRB decision (see link for Appealing Adverse IRB Dispositions).