SOCIAL PROTOCOL (HRP-580)
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       INSTRUCTIONS:
                ● Use “SOCIAL TEMPLATE PROTOCOL (HRP-580)” to prepare a social-behavioral study
                  (see  Investigator     Manual     (HRP-103)  for a definition of social-behavioral research).
                ● For social-behavioral research involving biomedical activities, refer to the 
                   Investigator     Manual     (HRP-103)  for further instructions as to whether the “MEDICAL
                  TEMPLATE PROTOCOL (HRP-590)” is required.
                ● Depending on the nature of what you are doing, some sections may not be 
                  applicable to your research. If so mark as “NA”. For example, research involving a 
                  retrospective chart review may have many sections with N/A.  
                ● Please do not delete sections if they do not apply to the study.
                ● We suggest that you use the word “participant” or “volunteer” rather than 
                  “subject” throughout your protocol. The reason is that “subject” has the sense of 
                  someone under the authority of the investigator while “participant” or “volunteer”
                  has the sense of a person who understands and is an important contributor to the 
                  research.
                ● After you submit your protocol for review in ETHOS, your protocol will be saved 
                  there. You should use that saved version as your starting point for edits to the next 
                  version. You may choose to track protocol versions for yourself outside of ETHOS; 
                  however, you should ensure that any version you edit is the same as the most 
                  recently approved version in ETHOS.
                ● As you are writing the protocol, remove all instructions in red so that they are not 
                  contained in the final version of your protocol.
                ● To update page numbers in the Table of Contents, right click on the table and select
                  “Update Field” and “page numbers only.”
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                                                 ANCILLARY REVIEWS
          DO NOT DELETE.  Submit the completed checklist below with your protocol.
                               Which ancillary reviews do I need and when do I need them?
                           Refer to HRP-309 for more information about these ancillary reviews.
          Select yes or   Does your study…                  If yes…                                   Impact on 
          no                                                                                          IRB Review
          ☐ Yes           Include Gillette resources, staf  Gillette Scientific review and Gillette   Required 
          ☐ No            or locations                      Research Administration approval is       prior to IRB
                                                            required.  Contact:                       submission
                                                            research@gillettechildrens.com  
          ☐ Yes           Involve Epic, or Fairview         The Fairview ancillary review will be     Approval 
          ☐ No            patients, staf, locations, or     assigned to your study by IRB staf        must be 
                          resources?                        Contact: ancillaryreview@Fairview.org     received 
                                                                                                      prior to IRB
          ☐ Yes           Include evaluation of drugs,      STOP – Complete the Medical Template      committee/
          ☐ No            devices, biologics, tobacco, or   Protocol (HRP-590)                        designated 
                          dietary supplements or data                                                 review.  
                          subject to FDA inspection?
                                                            The regulatory ancillary review will be 
                                                            assigned to your study by IRB staf        Consider 
                                                            Contact: medreg@umn.edu                   seeking 
                                                                                                      approval 
                                                            See                                       prior to IRB
                                                            https://policy.umn.edu/research/indid     submission.
                                                            e 
                          Require Scientific Review? Not    ONLY REQUIRED BIOMEDICAL 
                          sure? See guidance in the         RESEARCH REVIEWED BY FULL 
                          Investigator Manual (HRP-103).    COMMITTEE
                                                             
          ☐ Yes           Relate to cancer patients,        Complete the CPRC application 
          ☐ No            cancer treatments, cancer         process. 
                          screening/prevention, or          Contact: ccprc@umn.edu 
                          tobacco?
          ☐ Yes           Include the use of radiation?                                               Approval 
          ☐ No            (x-ray imaging,                   Complete the AURPC Human Use              from these 
                          radiopharmaceuticals, external    Application and follow instructions on    committees
                          beam or brachytherapy)            the form for submission to the AURPC      must be 
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                                                          committee.                              received 
                                                          Contact: barmstro@umn.edu               prior to IRB
                                                                                                  approval; 
          ☐ Yes          Use the Center for Magnetic      Complete the CMRR pre-IRB ancillary 
          ☐ No           Resonance Research (CMRR)         review    
                         or MR at Masonic Institute for   Contact: ande2445@umn.edu               These 
                         the Developing Brain (MIDB) as                                           groups 
                         a study location?                                                        each have 
          ☐ Yes          Include the use of recombinant   STOP – Complete the Medical Template    their own 
                         or synthetic nucleic acids,      Protocol (HRP-590)                      application 
          ☐ No                                                                                    process. 
                         toxins, or infectious agents?
          ☐ Yes          Include the use of human fetal   STOP – Complete the Medical Template
          ☐ No           tissue, human embryos, or        Protocol (HRP-590)
                         embryonic stem cells?
          ☐ Yes          Include PHI or are you           If yes, HIPCO will conduct a review of 
                         requesting a HIPAA waiver?       this protocol.
          ☐ No
                                                          Contact: privacy@umn.edu 
          ☐ Yes          Plan to use CTSI Monitoring      The CTSI monitoring ancillary review    Approval 
                         services, and/or have an IND,    will be assigned to your study by IRB   must be 
          ☐ No                                            staf.
                         IDE, or designated NSR-IDE by                                            received 
                         the UMN IRB?                     Please note eligibility criteria here.  prior to IRB
                                                          Contact: fencl003@umn.edu               approval.
          ☐ Yes          Use data from CTSI Best          The Information Exchange ancillary 
          ☐ No           Practices Integrated             review will be assigned to your study 
                         Informatics Core (BPIC)          by IRB staf                             These 
                                                                                                  groups do 
                         Formerly the AHC Information     Contact: bpic@umn.edu                   not have a 
                         Exchange (AHC-IE)?                                                       separate 
          ☐ Yes          Use the Biorepository and        STOP – Complete the Medical Template    application 
          ☐ No           Laboratory Services to collect    Protocol (HRP-590)                     process but
                         tissue for research?                                                     additional 
                                                                                                  information
                                                          The BLS ancillary review will be        from the 
                                                          assigned to your study by IRB staf.     study team 
                                                          Contact: Jenny Pham                     may be 
                                                          Pham0435@umn.edu                        required.
          ☐ Yes          Have a PI or study team          The CoI ancillary review will be 
          ☐ No           member with a conflict of        assigned to your study by IRB staf
                         interest?                        Contact: becca002@umn.edu 
          ☐ Yes          Need to be registered on         If you select “No” in ETHOS, the 
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          ☐ No             clinicaltrials.gov?                clinicaltrials.gov ancillary review will 
                                                              be assigned to your study by IRB staf
                                                              Contact: fencl003@umn.edu 
          ☐ Yes            Require registration in            If you select “No” or “I Don’t Know” in     Does not 
          ☐ No             OnCore?                            ETHOS, the OnCore ancillary review          affect IRB 
                                                              will be assigned to your study by IRB       approval.
                                                              staf
                                                              Contact: oncore@umn.edu 
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