Institutional Review Board

Drew University Procedures for Approval of Human Subjects Research

Categories of Human Subjects Research Review:

Exempt Research:

It is expected that most of the human subjects research performed at Drew University will be exempt from IRB review.  The complete list of types of research exempt from IRB review can be found in 45 CFR, Subtitle A, Part 46.101b.  An abbreviated list containing types of exempt research commonly conducted at Drew can be found here.

Principal investigators of research exempt from IRB review must submit 1) an IRB Exemption Form and 2) a Human Participant Research Review Form.   The IRB Exemption Form will be reviewed by the IRB chair.  There are two possible outcomes of this review:  i) approval, or ii) referral for an expedited or full IRB review.  This determination will generally be made within two weeks of the submission of the form. 

A protocol which has been approved for exemption from the IRB review process requires no further action from the investigator prior to initiating the study. If the study should extend beyond 12 months, the investigator should send a letter to the IRB chair, informing her/him of the current status of the project, any changes in the protocol, and whether any adverse events have occurred.   If a protocol is denied approval for exemption, it can be submitted for expedited or full IRB review.

Written verification of the exemption or of the referral for IRB review will be sent to the investigator and to the Human Protections Administrator.  The Human Protections Administrator will keep this written record as well as the original IRB Exemption Form on file for at least three years. 

Expedited Review:

It is expected that almost all of the human subjects research conducted at Drew University that is not exempt from review will qualify for expedited review.  Expedited review is used for research that presents no more than a minimal risk to human subjects.  Minimal risk means that 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. (45 CFR, Subtitle A, Part 46.102.i)   The complete list of types of research that are eligible for an expedited review can be found in 45 CFR, Subtitle A, Part 46.110.  An abbreviated list containing types of research commonly conducted at Drew can be found here.

Principal investigators of research requiring an expedited IRB review must submit the following:  1) an Application for Review of Human Subjects Research Form, 2) a Human Participant Research Review Form, and 3) all accompanying documents as specified in the Application for Review of Human Subjects Research Form.  Expedited reviews will be performed by the chair of the IRB and at least one other member of the IRB, at the discretion of the chair.  There are three possible outcomes for protocol reviewed by the expedited process:  i) approval, ii) revise and resubmit, or iii) referral for a full IRB review.  A protocol cannot be denied via the expedited process.  An expedited review is usually accomplished within two weeks of application.

A protocol which has been approved by the expedited IRB process requires no further action from the investigator prior to initiating the study. If the study should extend beyond 12 months, the investigator should send a letter to the IRB chair, informing her/him of the current status of the project, any changes in the protocol, and whether any adverse events have occurred.   A protocol that has been deferred by the IRB usually requires that additional information be submitted to the IRB prior to approval. A revised application should be submitted to the IRB clarifying the issues involved or providing the requested documentation. The IRB will review the revised application at its next meeting.  A protocol can not be denied approval by the expedited process but can be referred to the full IRB. 

If the research is approved, written verification of the approval will be sent to the investigator and to the Human Protections Administrator.  Any other outcome of the review process will also be given in writing to the investigator and to the Human Protections Administrator.  The Human Protections Administrator will keep this written record as well as the review application documentation provided by the investigator on file for at least three years. 

Full IRB Review:

Full IRB Review is necessary when the research involves any of the following:

1. Prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively impaired adults as subjects;
2. The collection or recording of behavior which, if known outside of the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, insurability, reputation, or be stigmatizing to the subject;
3. The collection of information regarding sensitive aspects of the subject's behavior such as drug or alcohol use, illegal conduct, or sexual behavior;
4. Research that does not fall into any of the categories defined as exempt in 45 CFR, Subtitle A, Part 46.110.

Principal investigators of research requiring a full IRB review must submit the following:  1) an Application for Review of Human Subjects Research Form, 2) a Human Participant Research Review Form, and 3) all accompanying documents as specified in the Application for Review of Human Subjects Research Form.  Full IRB reviews will be performed by all members of the IRB.  There are three possible outcomes for protocols reviewed by the full IRB:  i) approval, ii) revise and resubmit, or iii) denial.    A full review is usually accomplished within three weeks of application.

A protocol which has been approved by the IRB requires no further action from the investigator prior to initiating the study. If the study should extend beyond 12 months, the investigator should send a letter to the IRB chair, informing her/him of the current status of the project, any changes in the protocol, and whether any adverse events have occurred.   A protocol that has been deferred by the IRB usually requires that additional information be submitted to the IRB prior to approval. A revised application should be submitted to the IRB clarifying the issues involved or providing the requested documentation. The IRB will review the revised application at its next meeting.  A protocol that has been denied approval by the IRB cannot be initiated by the investigator. The reasons for the denial are provided in writing. The investigator will be given the opportunity to appeal the denial either in writing or in person at the next meeting of the IRB. 

If the research is approved, written verification of the approval will be sent to the investigator and to the Human Protections Administrator.  Any other outcome of the review process will also be given in writing to the investigator and to the Human Protections Administrator.  The Human Protections Administrator will keep this written record as well as the review application documentation provided by the investigator on file for at least three years. 

Procedures for Continuing Oversight of Ongoing Research

In general, if the research goes on for more than one year, approval by the IRB must be obtained at least annually.  High-risk procedures may require more frequent review.   If the IRB deems that a protocol warrants a more frequent review, the written record of the IRB process which is sent to the investigator and to the Human Protections Administrator upon completion of the review will stipulate when a re-approval is required.  The re-approval may be obtained through expedited review if no significant changes have been made to the protocol, at the discretion of the chair of the IRB.

Education Requirements

NIH Guidelines stipulate that key personnel, that is, those responsible for the design and conduct of a study, should complete training in the responsible conduct of research involving human subjects.  There are a number of ways to meet this requirement, among them:

• to complete the U.S. National Institutes of Health, National Cancer Institute, Human Participant Protections Education for Research Teams online training module;
• or to attend a class or seminar where the main purpose is to discuss the responsible conduct of research involving human subjects.