New Study Submission

You will create a new study in PROTECT, using the IRB Researcher’s Guide that is found within PROTECT. There are many documents that you will need to attach to the new study submission for the IRB to review. Once you have attached all the relevant documents, and obtained the applicable ancillary review approvals, you may submit your study for IRB review.

Refer to the NIH policy that outlines the requirements for IRB submissions:

When you submit documents within PROTECT, make sure each electronic file has a consistent format. This includes naming folders and files correctly to ensure that required information is maintained and easily accessible. 

Here are the documents you need to submit for IRB review via PROTECT:

Documents that the subjects will not see

• Protocol
  • Protocol addendum if applicable
• FDA approval information and letters from the FDA
• Device specifications
• Drug Investigator Brochures/Package Inserts (see the following document for more information on these)

**Please note that Study Manuals or SOPs do not need to be submitted to the IRB for review.

Documents that the subjects will see

• Consent forms, assent forms, verbal or online scripts, consent addendums
• Recruitment materials, i.e., flyers, advertisements, website postings, letters, emails, social media posts, scripts for television or radio ads
• Study instruments, including:
  • Questionnaires
  • Interview questions
  • Interview/focus group guides/scripts
  • Drug diaries to be completed by subjects
  • Tracking logs (temperature) to be completed by subjects
  • Assessments specific to the study
• Communications/videos that will be shared with subjects that:
  • Provide research-specific information to subjects including risks
  • Disclose the study condition/treatment/arm to which they were assigned when a study has been unblinded
  • Describe new information about study progress or study procedures
    

Depending on the study, the IRB may request additional documents required to make regulatory determinations.

Some documents do not require IRB review as long as they contain information that is consistent with the protocol or other IRB reviewed documents and do not include new information that would affect subjects’ willingness to take part in the study. Do not submit these documents for IRB review.

These include:

• Appointment reminders
• Case report forms
• Course curriculum content
  • When the content of the course is established and will not be altered for the research study
• Data collection forms
  • Note: This does NOT include surveys and other instruments which are used to collect data directly from subjects. These do require IRB review.
  • However, the data collected on these forms does need to be described in the application/ protocol.
• Eligibility determination sheets/forms/checklists to be completed by the study team
  • Note: This does not include telephone screening scripts. These do require IRB review.
• Instructional materials for subjects
  • If the materials are limited to the technical description of procedures (e.g. specimen collection) or medications described in the study protocol and do not contain information about study risks.
• Newsletters/press releases
  • When the content does not include recruitment information, or describe study results specific to a participant(s), or unpublished findings/results of initial data analysis. However, participants may be sent, without IRB review, information on the number of subjects enrolled, study status, and publications resulting from the study or lay language summaries of such publications.
• Internet postings of study descriptions limited to CT.gov-style content (i.e., study title, purpose, procedures, basic eligibility criteria, and how to get in touch with the study team) as long as the methods used to recruit subjects are described in the application/protocol (e.g. The Internet must be an approved tool for recruitment).
  • This does NOT include descriptions of risks/benefits or why someone would want to be in the study.

1. Pre-review Clarifications: Before the IRB reviews your submission, an IRB Analyst will check it to make sure everything is complete. They might ask for more information or corrections through PROTECT. This step helps to fix any issues that could delay approval before the IRB looks at your protocol.
   
2. Expedited Review vs. Full Board:
   1. Expedited Review: If your protocol qualifies for expedited review, either an IRB Chair or an experienced IRB member chosen by the Chair will review it for approval. The approval period starts on the day the designated reviewer approves your research and lasts until the study is closed or until a specific date as per Continuing Review (CR) requirements.
      OR
   2. Full Board IRB Review: For approval, a fully convened IRB must review your protocol. Your protocol will be assigned to a specific meeting date
      

Possible IRB Determinations after Expedited Review of the protocol:

• Approved: Your protocol is approved, and you can begin your research.
• Modifications Required to Secure Approval: The Expedited Reviewer has decided that you need to modify your initial submission to meet the IRB approval criteria. This could involve changes to the protocol or consent forms, providing more information, or taking additional actions. The Expedited Reviewer will work with you to make sure your protocol meets all the approval requirements.

During the expedited review process, new information might come up that requires your protocol to be reviewed by the Full Board instead. The Expedited Reviewer or IRB Analyst will inform you about the reason for this change.

Possible IRB Determinations after Full Board Review of the protocol:

• Approved: Your protocol is approved, and you can begin your research.
• Modifications Required: You need to make some changes to your protocol before it can be approved.
• Deferred: More information or significant changes are needed before a decision can be made.
• Disapproved: Your protocol is not approved, and you cannot proceed with the research as proposed.