Completing The Annual Signatory Institution Worksheet

OVERVIEW

This Quickguide provides instructions for completing the Annual Signatory Institution Worksheet.

BEFORE YOU BEGIN

  • Consider printing a copy of the Worksheet by clicking here to use as reference as you complete the Worksheet in IRBManager.
  • The Worksheet should be completed by the Signatory Institution Primary Contact or designee.
  • Use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to change the auto-populated information relating to the person submitting and the name of the institution.  For more information, go to Updating Your CIRB Person Roster.  
  • If you are at a Consortia site, go to Navigating the CIRB as a Consortia Site for information on how processes vary for you.

INSTRUCTIONS

The Signatory Institution Primary Contact or designee should answer all questions on the Annual Signatory Institution Worksheet found in IRBManager.
 
The first time you complete the Worksheet, check the box indicating that this is a first submission. Indicate revised submission in subsequent Worksheets submitted after initial approval.
 
Steps

COMPLETE THE SIGNATORY INSTITUTION INFORMATION QUESTIONS

  • Question 1:  This determines the types of studies your investigators plan to conduct and the CIRB(s) that would be relied upon. Select all that apply to your investigators.
  • Question 2:  This is a list of Component Institutions that auto-populates from RUMS.  If you need to make changes to the list, go to Updating Your CIRB Institution Roster.
  • Question 3:  This is a list of Affiliate Institutions that auto-populates from RUMS.  If you need to make changes to the list, go to Updating Your CIRB Institution Roster.
Steps

COMPLETE THE STATE AND LOCAL LAWS QUESTIONS

  • Question 4:  The CIRB needs to know about any state or local laws that govern who may act as a legally authorized representative (LAR). Enter this information into the text box or cite a reference and include as an attachment.
  • Question 5:  The CIRB needs to know about any other state and local laws that may impact the research at your institution. List any of these laws (e.g., a state Bill of Rights) in the text box or cite a reference this and include as an attachment.
  • Question 6:  In order to know who is considered a minor in your state, the CIRB needs to know the age of consent in your state.  Enter the age of majority in the text box.
Steps

COMPLETE THE RESEARCH OVERSIGHT QUESTIONS

  • Question 7: If your institution does not have an IRB, you can still enroll in the CIRB. However, there are additional steps required to obtain approval from the CIRB. Contact the CIRB Helpdesk directly to discuss these steps.

 

 NOTE:  If you are associated with an IRB at a Signatory Institution – in other words, an IRB that reviews the institution’s research as part of a human research protection program – you would be considered part of the “umbrella” IRB. This applies even when you’re not physically located at the Signatory Institution.

 

EXAMPLE:  A children’s hospital associated with a university that relies on the university’s IRB would be considered to have an IRB.

 

 

  • Question 8:  This provides the CIRB a contact person at the institution who is not directly involved in the research (consenting study participants or conducting study visits) who can assist the CIRB with the resolution of any issues arising at the institution. This person cannot be the PI or a research nurse and should have authority to resolve any issues regarding the PI or the research team. The questions listed under the request for contact information are related to how this individual fulfills these five institutional requirements outlined on the Authorization Agreement.  For more information, go to Oversight Q&A.
  • Question 9:  This provides the CIRB the name of the liaison at your institution who will communicate with the CIRB regarding potential unanticipated problems and serious or continuing noncompliance. The question listed under the request for contact information provides the CIRB details on how the institution identifies, reviews, and manages potential unanticipated problems and serious or continuing noncompliance.  For more information, go to Completing the Unanticipated Problem and/or Noncompliance Reporting Worksheet.
Steps

COMPLETE THE FINANCIAL CONFLICTS OF INTEREST QUESTION

  • Question 10:  To assess whether there may be a financial conflict of interest, the CIRB must be informed of the institution’s policy for obtaining and assessing investigators and their research teams. The institution’s policy must identify when a conflict of interest-related management plan is required and who is responsible for creating and enforcing the management plan.
Steps

COMPLETE THE INSTITUTIONAL POLICY QUESTIONS

  • Question 11:  Provide your institution’s policy related to the informed consent document.
  • Question 12:  Boilerplate language is the institution’s standard template language that is inserted into a CIRB-approved model consent form. The CIRB is only interested in the language used for studies that would be open using the CIRB.  For more information, go to Boilerplate Language Q&A.
  • Question 13:  If your institutional consent form contains a letterhead or logo, attach it here.
  • Question 14:  Include other documents used at your institution like a Bill of Rights or a letter to study participants about an IRB change.
  • Question 15:  After the boilerplate language is approved, all studies opened under the CIRB must use the boilerplate language. Provide the timeline for implementing boilerplate changes to CIRB studies.  

NOTE: Describe the timeline for implementing changes to studies currently open under the CIRB. Depending on the types of changes, the institution may decide that the changes need to be made before anyone else is consented or it may be determined that they are administrative in nature and do not require that current consent forms be updated until the next study amendment.

Steps

COMPLETE THE COMMUNITY DESCRIPTORS QUESTIONS

  • Question 16:  This question assesses the community served by your investigators and their attitudes towards research. Indicate whether there is a positive attitude towards research; if not, list the steps that have been taken to counter the negative perception of research.
  • Question 17:  Identify specific characteristics about your area’s population and whether there are any vulnerable populations regularly served by your investigators.
Steps

ADDITIONAL INFORMATION

  • Question 18: Identify any other local context considerations regarding your population.  For example, you may serve a large ethnic population, or a population with a low literacy rate.
Steps

ADDITIONAL MATERIALS FOR REVIEW (IF APPLICABLE)

  • Question 19: Attach translated boilerplate language, short forms, and any other documents used across studies. The following items are required when submitting translated materials: a certificate of accuracy, the CIRB-approved English language document, and the translated document. For verification, it is required that all three documents reference the same version or version date.  
  • Question 20: Attach any documents that are provided to study participants but that are not study-specific. For example, some institutions use a template assent form or consent at age of majority documents. If you use these templates and they do not contain any study-specific information or information copied directly from the protocol or consent form, CIRB approval for use on all studies will be granted.

USEFUL TIPS

If you find you have any questions completing this Worksheet, contact the CIRB Helpdesk.

 

Posted: June 15, 2017