Midterm Assignment: Completion of an IRB Application Form

For the midterm assignment you will be completing an IRB application for “your research site”. To complete the IRB application, you will use the protocol (and possibly the supporting documents) in your textbook titled A Clinical Trial Workbook.

In some sections of the IRB application, you will need to provide some information that may not be included in the textbook. You are free to gather this information from other sources, such as medical websites, statistical websites, etc.

Use the attached Word document above – MIDTERM ASSIGNMENT_IRB.APPLICATION_VerJAN2019-2.docx – to complete the assignment. Use of this document is mandatory, as it has been designed specifically to meet the intent of the Midterm. Please note: this is not a true reflection of the information required by an IRB to review and approve a research study.

I realize there is a lot of reading in this course, but please read the Instructions in the application to assure you receive the maximum points for each section.

Be sure to cite any references you use to complete this assignment. Citations/references would be appropriate for a number of the application sections, such as the background & objectives, study population, and consent process. Include the reference list on the last page of the application form. You must include 3 references. NOTE: Your Oxford textbook will count as only one reference, even if you cite different chapters. The study protocol and supporting documentation in the Clinical Trial Workbook are not considered references for this assignment; so DO NOT cite/reference them in the application.

ADDITIONAL REQUIREMENT: While the protocol does not specify that vulnerable populations will be recruited for this study, your study site MUST be enrolling one of the following populations:

Patients living in or from a developing country; such as Africa, the Arab World, the Caribbean, Central America, India, Southeast Asia, etc.
Unique populations: such as children, pregnant women, prisoners, Native Americans, indigenous people, or religious communities (nuns, monks, missionaries, etc.)

Be sure to note the vulnerable population you’ve selected in the IRB application. IMPORTANT: You’ll also need to address the ethical/scientific rationale for including that population as a key group for enrollment.

This midterm assignment draws upon your knowledge of ethical principles and research regulations and your responses to the application questions should reflect that knowledge. But keep in mind, an IRB would know the regulations. So you need to tell them how your site will be compliant.


Federal Regulations Links

DHHS OHRP Policy and Guidance Library (Links to an external site.)
DHHS Regulations on the Protection of Human Subjects (45 CFR 46) (Links to an external site.)
FDA Regulation on the Protection of Human Subjects (21 CFR 50) (Links to an external site.)
FDA Regulation on Institutional Review Boards (21 CFR 56) (Links to an external site.)
FDA Regulations on Investigational New Drug Application (21 CFR 312) (Links to an external site.)
FDA Regulations on Investigational Device Exemptions (21 CFR 812) (Links to an external site.)

Other Resources

The Belmont Report (Links to an external site.)
Comparison of FDA and DHHS Human Subjects Protections Regulations (Links to an external site.)
Nuffield Council on Bioethics (Links to an external site.)

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