IRB Protocol Development Assistance

These collected resources can help when you're developing IRB protocols and related materials. If you have further questions after reviewing these materials, please contact our office. We also encourage students and residents to work with their advisors during this process.  

  1. The principal investigator (PI) should write the protocol because he or she understands the project and its purpose. 
  2. Start with the protocol because other documents build on that information.
  3. Other documents to create early in the process include the data collection instruments.
  4. If you're new to this IRB process, ask someone to review your protocol before proceding to the other documents.

 

BRO/CRO Recomended Guidance Materials

Guides for Material Preparation

This quick reference helps with information commonly used in Click IRB.

Illustrated step-by-step guide to most common Click IRB transactions.  While we are still developing additional sections for this guide, we did not want to delay publication of the sections that are complete. 

Click IRB Page

Quick references for some common transactions when using Click IRB.

The guide contains directions, examples and sample text for filling out HRP-503, the protocol template. It correlates with the IRB template to be released in January 2016.  It will be updated to correspond more exactly with the HRP-503 template once the IRB posts a finalized version of HRP-503.

*If you are using an earlier version of HRP-503, the information is the same although the numbering might be off. You can use keywords to assist in your search. 

 

Submission Checklists

Using the checklists helps ensure that you have included everything the IRB needs to review your submission.

Additional Items for Clinical Studies

If applicable, please submit the following with the information on your clinical studies.

Selected IRB Toolkit Items

You can find the complete toolkit within the Click IRB system or on the IRB Toolkit page. The following are some of the most commonly used items.

Templates and HIPAA

1. Write your protocol first because every human subjects study will need to include one of the following:

  • HRP-503; OR
  • HRP-508 (only used for sponsored clinical trials that include a sponsor's protocol)

2. When your protocol is complete, start working on consent documents.

  • A change in the protocol will necessitate a change in the consent document. 
  • Most studies with participant intervention or interaction also will require a consent document, information sheet or script.

*UB researchers cannot use the short, signed-consent form except in very limited and well defined circumstances.

Research in Schools

You must include an HRP-504 when you or a member of your research team will be entering a school.

If you are merely mailing or sending information, documents or materials to students then do NOT use an HRP-504.

Research in Health Care

Use the HIPAA templates when working in a health care setting or accessing protected health information from medical/clinical records.

Standard Operating Procedures and Manuals

Worksheets

Do NOT submit your worksheets and checklists in the Click Portal IRB. Rather, use them as guides to understand the IRB regulatory criteria used in approving a study so you can construct your protocol accordingly.