Version 4.3

June 11, 2018

Many of the changes in RM 4.3 are meant to support the U-M Office of Research Flexibility Initiative which seeks to leverage burden reduction actions for Non-Federally sponsored research. These changes will also support Common Rule changes for Federally sponsored research when the rule changes are implemented (expected implementation is January 19, 2019). These and other improvements are summarized below.  Additional details and screenshots are provided in an Overview of Changes.

For All RM Users

Reorganization of Section 1-1 Application Type

  • The standard application type has been replaced with a new type that encompasses research involving subject interaction or intervention.
  • The exempt categories and associated questions have been updated to match the pending Common Rule Changes.
  • The opportunity to select exemptions 1, 2, 3, 5, and 6, now appear after selecting Research Involving Subject Interaction/Intervention if certain conditions are met.
  • Qualification for Exemption 4 is now determined as part of the Secondary research application type.

Impact to exempt applications created prior to June 10, 2018

(Including all previous exemption types 1, 2/3, 4, 5, and 6)

  • If the exempt application only needs general study data edited or updated, changes or amendments can be submitted.
  • Sections 1-1.1, 5-3, and the applicable Section 12 continue to display, however these question sets are no longer editable.
  • Studies created prior to June 10 that are incomplete or require changes to Section 1-1.1, 5-3, or Section 12 questions should be withdrawn and a new study should be created and submitted.
  • The Jump To menu for Section 12 will display both the pre-2018 exemption pages and the new exemption pages.

New question sets to determine if eligible for exemptions

  • Exemption question sets 1, 2, 3, 5, and 6 display in section 12.
  • Exemption 4 question set displays in section 1-1.2.

Some exempt applications now qualify for self-determined approval

  • If your application qualifies for self-determination you will be given the option to generate a self-determination letter or submit the application for IRB review.
  • Amendments and AE/ORIOS are still required for these studies when applicable.

Continuing Review no longer required for qualifying Non-Federal studies

  • Qualifying studies will be given a no continuing review determination. These studies will no longer see an option to create a new Continuing Review.
  • A No Continuing Review Required message will show on the application’s main tab.
  • Amendments and AE/ORIOs must still be created/submitted when applicable.

Termination Report is no longer embedded within Continuing Review

  • To create and submit a termination report use the create new Termination Report button located in the left hand navigation bar.
  • See the step-by-step procedure for more information.

Informed Consent questions 10.1 and 10.2 have changed

  • The answers have been organized under subheadings.
  • In most cases, answers selected prior to June 10, 2018 will display and do not need re-answering.
  • In some cases, questions 10.1 and/or 10.2 must be fully re-answered. These cases involved answers that could not be directly converted:
    • Request for Waiver of Informed Consent - Adults,
    • Request Waiver of Documentation of Parental Informed Consent/Permission, or
    • Request for Waiver of Documentation of Child’s Assent

External Sponsor questions removed from Section 2, plus new Section 2 question

  • External sponsors will now be indicated by selecting/linking a Proposal Approval Form (PAF) from the Proposal Management system (eRPM). See the updated step-by-step procedure.
  • Studies with previously linked PAFs will maintain those links.
  • Unfunded Agreements (UFAs) can now be linked to an application.
  • External sponsor data (other than PAF ID) entered prior to June 10, 2018 will display in a linked view for historical purposes only. That data should not be used for regulatory review.
  • Certain PAF and UFA data will be imported and displayed in the Regulatory Management System. This data will display in both the application and in the Related Projects tab.
  • A new question 2.1 regarding external funding must be answered if PAF was not previously linked:
    • 2.1 Please select all Proposal Approval Forms (PAFs) and/or Unfunded Agreements (UFAs) associated with this study.
  • A new general question has been added and must be answered.
    • 2.4 Is there any other financial or non-financial sponsorship or support not covered in the sections above?

Additional changes made to Secondary Use Applications only

  • Question 5.8 added to Sections 05 and 05-2 if Secondary Use Application
    • New question text: 5.8* The primary risk of conducting research with secondary data or specimens is a breach of confidentiality or privacy, which may cause psychological, social/reputation, legal, or financial harm. Indicate any risks to subjects other than these risks from a breach of confidentiality or privacy. If there are none, answer “none.”
  • Sections removed from Secondary Use application:
    • Section 06-1 Benefits and Risks - Secondary Use
    • Section 07 Special Considerations
    • Section 09-2 Subject Populations - Secondary Use
  • Section 18 changes
    • Do not display questions 18.1.1 and 18.1.4 on secondary use applications that are analysis only.
    • Reword question 18.2 for all application types
      • New text: 18.2* Will the investigators receive or record direct or linked subject identifiers for ANY biospecimens?
    • Remove question 18.2.1 from all application types
      • Removed question text: What action(s), if any, will be taken in the event that the research reveals information of potential benefit to the subject or identifies a clinically significant, unexpected disease or condition?
  • Section 24 changes
    • Add question text to 24.2 for all application types
      • New text: 24.2* Name, source, and location of data set. ALSO, describe how you gain access to the data set.
    • Add question text to 24.3 for all application types
      • New text: 24.3*  Describe the type of information contained in the data set, including any potential subject identifiers. If a data dictionary is uploaded in 24.6 or included in a separate protocol, refer to it here.
    • Remove question 24.4 from all applications types
      • Removed text: Is the data set you are analyzing publicly available?
    • Reword question text and answer options for 24.5 for all application types AND renumber to 24.4
      • New text: 24.4* Please confirm whether the investigators receive or record identifiers from THIS dataset. (Select all that apply)
        • Direct Identifiers - stored on data record (e.g. name, initials, phone number, SSN, or medical number stored on data record)
        • Coded or Indirect Identifiers - data record includes a link to direct identifiers, or unique subject characteristics, or a combination of data fields that can be correlated to another dataset
        • No Identifiers - De-identified, Anonymous, or Anonymized) - stored date record is stripped of all identifiers
    • Reword question text for 24.6 for all application types AND renumber to 24.5
      • New text: 24.5 Upload
        • Agreement (DUA/DSA) - unsigned template is acceptable. Upload is not necessary if this application refers to an Unfunded Agreement (UFA) in eResearch Proposal Management.
        • Data dictionary/data collection sheet/list of data variables to be accessed or received by study team and recorded for analysis. Upload is not necessary if the variables are fully described in 24.3 or in a separate protocol.
  • Section 33-1 will apply only to full secondary use applications; it is not applicable if Exemption 4 applies.

For IRB Staff and Reviewers

  • IRB Staff have a new activity to indicate when a study is being evaluated under the new rules: Update Common Rule Status. See the step-by-step procedure for details.
  • The IRB tab will now include the following question under the Study Information heading: Does the study conform to the 2018 Revised Common Rule or to institutional practice?
    • Absence of an answer means no determination has been made.
    • A Yes or No answer means a determination has been made and recorded via the Update Common Rule Status activity.
  • New methods for indicating a Continuing Review is No Longer Required have been added to the expedite and record full committee decision processes. See the support material for details.
  • PAF related display fields have been updated on the Link Related Projects activity and the Related Projects tab.