老司机福利网

The type of application you鈥檒l need to complete depends on a few factors: the nature of the research (biomedical or not), risk level and whether certain regulatory criteria are met. It is important to choose the right IRB application, as forms are not inter-changeable and selecting the wrong application could result in duplicate work.

There are three types of IRB review:

Exempt Review: Studies that involve minimal risk and can be justified under one or more of the exempt categories of review. Choose the Biomedical Exempt Application or Social, Behavioral and Education Exempt Application depending on the nature of the research.

Expedited Review: Studies that involve minimal risk and can be justified under one of the expedited categories of review. Choose the Biomedical Research Application or Social, Behavioral and Education Research Application depending on the nature of the research.

Full Board Review: Studies involving more than minimal risk or those that do not fit exempt or expedited review categories. Choose the Biomedical Research Application or Social, Behavioral and Education Research Application depending on the nature of the research.

See Tips for Choosing the Appropriate IRB Application for more information.

The following technical resources may help you prepare your application in eIRB:

• New Protocol Submission Quick Sheet
• How to Turn Off Pop Up Blocker
• More eIRB Tips can be found on the Forms and Guidelines page.

Need Support? Contact 314-977-7744 or irb@slu.edu.

Have feedback? Send feedback using the .

Emergency Use Treatment

An Emergency Use Treatment Form should be submitted for the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to proactively obtain IRB approval [21 CFR 56.102(d)]. This form is not in eIRB; once completed, email to irb@slu.edu with any supplemental information.

Prior to the use of the test article, please verify whether the article has been used previously at SLU, and contact the IRB for reporting requirements, including the requirement to obtain informed consent [21 CFR 50.23(a)].

For additional guidance, please refer to the SLU IRB Guidelines for Emergency Use of Test Articles.

• Emergency Treatment Form
• Emergency Use Informed Consent Template
• Emergency Treatment Status Update/Closure Form

Humanitarian Use Device (HUD)

As defined in 21 CFR 814.3(n), and updated by the 21st Century Cures Act, a HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.

Though not research, use of a HUD requires prior approval by the IRB. The HUD Application is not in eIRB. Use the forms below to request IRB approval to use an HUD; once completed, email to irb@slu.edu with any supplemental information. See the HUD Submission Guidelines for more information.

• Humanitarian Use Device (HUD) Application
• Humanitarian Use Device (HUD) Protocol Instructions
• Humanitarian Use Device (HUD) Consent Form Template

If the IRB Application indicates that your study is one that requires a consent process, the appropriate SLU template(s) should be customized for use in your study. Descriptions of each are below.

Recruitment Statement Template
For projects where the use of a full written informed consent document is not indicated, but subjects still need to be informed about the research (i.e. exempt research and certain types of minimal risk research)

Biomedical (Clinical) Informed Consent Template
For biomedical/clinical projects submitted on the full IRB application (not exempt studies)

Behavioral & Social Sciences (Non-clinical) Consent Template
For behavioral and social sciences/non-clinical projects submitted on the full IRB application (not exempt studies)

HIPAA Authorization Form
At SLU, HIPAA Authorization Forms are separate from the consent document. If your study requires HIPAA Authorization, you must obtain signatures and maintain both documents for each research participant.

Lay Language Glossary for Consent Forms
This document contains lay language text alternatives to standard medical terms.

Assent Form Templates
For use in studies that enroll minors who must provide assent, as approved by the IRB:
Adolescent (Age 15-17) Clinical
Adolescent (Age 15-17) Non-Clinical
Child (Age 7-14) Clinical
Child (Age 7-14) Non-Clinical

Addendum Consent Document
For subjects who are already enrolled on a project and need to be informed of new information or changes relating to that project.

Short Form Consent Process
For use in studies that were not intending to enroll non-english speaking (NES) participants, but a potential NES participant presents and must be enrolled in a time window that does not allow for full translation of the English consent form and HIPAA Authorization form, if applicable.

For more information see Guidelines For Studies Involving Non-English Speaking Subjects.

If a participant speaks a language other than what is provided below, the English version can be used to translate into the targeted language. (A verification of translation must be submitted with the translated short form).

• Bosnian
• Chinese
• English
• Spanish

Verification of Translation for External Requests

Single Use Consent Template
For use in Single Use Applications (when a physician or researcher plans to treat a single patient who is not enrolled in a research study with an investigational drug, biologic or device). Single Use applications are submitted on the Biomedical Expedited/Full form in eIRB.

ClinCard Research Participant Employee Payment Supplemental Form
This optional form can be used to capture payment preferences of research participants are who employees of SLU. This form does not need to be submitted to the IRB. It is pre-approved for use.

Supplemental and miscellaneous forms related to IRB submissions can be found in the Forms Listing located on the Forms and Guidelines page of the IRB website.

Submission deadlines pertain only to items that require SLU IRB full board review. Exempt or expedited protocols need not be submitted according to these deadlines.

Please note that while normally IRB review of submissions will take place according to deadlines and meeting dates below, in some cases (capacity issues or incomplete submissions), review may be moved to subsequent meetings, as needed. Investigators are encouraged to submit in advance of the deadline date, as reviews will make the meeting agenda on a first-come, first-serve basis.

Full Board Meeting Dates and Deadlines can now be found here.

Submitting the application in eIRB is a multi-step process. The first time you submit the form, it requires you to search for and select pre-reviewers (see Scientific and Department Chair Approval section for more detail).

Once the pre-reviewers have approved, you can see their review comments and make edits to the application. You must then click to submit the form again, this time to the IRB. For more information, see:

• How to Submit Your eIRB Protocol (5 min.)

Before submission of new protocols to the IRB, all studies require review and pre-approval from a department chair (or faculty advisor for students). In addition, unsponsored, investigator-initiated, non-exempt research protocols must be pre-reviewed and approved by a departmental or divisional scientific review committee or representative. See Guidelines for Scientific Review for more information.

Scientific review must be completed by a qualified individual (not a student) who is not on the research team. Investigators are allowed to select the scientific pre-reviewer; however, many units have designated individuals who must be selected to complete the review. See Department/Division-Specific Guidelines for eIRB Submission Pre-Review Requirements.

Questions about the division requirements or quality or timeliness of scientific review should be directed to unit leadership.

For help assigning pre-reviewers, please see the "Submitting the eIRB Application" section above.

Performing a Pre-Review

The pre-review process is conducted within the eIRB system. The following tools can help:

• eIRB Pre-Review (Dept Chair/Advisor or Scientific Review Approval) Quick Sheet
• eIRB Pre-Review (Dept Chair/Advisor or Scientific Review Approval) Guide

Scientific reviewers are asked to review projects for adequacy of background literature review, appropriate scientific design, data analysis and safety oversight and may use the Scientific Review Worksheet to assist them in their review. Department chairs assure that the PI has the requisite funding, credentials, training, resources and privileges to do the research.

If the review was missed in eIRB, you can use the Department Chair Approval Form or Scientific Reviewer Form found at the end of the Guidelines for Scientific Review and upload the form to the Attachments page of the eIRB Application.

Commonly, initial IRB review results in requests for revisions prior to issuance of full approval. The timeline for review of PI responses is typically shorter than that for initial review. Researchers can enable the most efficient follow-up review of the study by carefully and completely addressing all IRB requests, and are welcome to work with IRB staff and chairs to do so.

Please follow instructions in eIRB for responding to any requests for revisions in order to receive full approval. Revisions must be submitted to the IRB in eIRB by clicking the "Submit to IRB" button, as they are not automatically sent when completed.