ARE YOU NEW TO DOING HUMAN SUBJECT RESEARCH?

 

10 STEPS TO FOLLOW TO GET STARTED

STEP 1   Complete CITI Training Certificate in Human Subject Protection  (www.citiprogram.org)

  • All study personnel engaged in research must complete online computer based human subject protection training.  Training is good for two (2) years.
  • Training does not need to be completed in one setting.  You may save your work at any point and resume training at a later time. 
  • Once completed the IRB will automatically receive notification from CITI.

STEP 2  Complete Conflict of Interest (COI) Training/Disclosure (http://app-4lc/coi/pages/home.aspx)

  • All study personnel engaged in research must also complete online computer based conflict of interest training.  This training is completed annually. (1 year)

STEP 3  Familiarize Yourself with the MCHS IRB website - Investigator Resources  (http://www.marshfieldresearch.org/orip)

  • Website contains useful and helpful information. 
  • See Investigator Resources
    • PI Responsibilities
    • Human Subject Determinations & IRB Review
    • IRB Policies, procedures and resource guides
    • IRB forms

STEP 4  Contact the IRB at ext. 93022 to receive training on the IRB's electronic submission system (iRIS)

STEP 5  Determine if study requires/qualifies for IRB Review (use only if uncertain about IRB review being needed.

  • IRB Review Determination Request form via iRIS

STEP 6  Create/review the Study Protocol

  • Review protocol if one already provided by a sponsor
  • Create protocol using the IRB forms - Protocol Template

STEP 7 Create/Review the Informed Consent Document

  • Review informed consent if one already provided by sponsor This consent may need to be modified to incorporate MCHS IRB specific language
  • Create informed consent using the IRB form - Consent Template

STEP 8  Fill out the appropriate IRB Application form for the study

  • Access form in the Policy & Handbook Library - Forms Directory under "I" for IRB
  • If already trained in electronic submission system (iRIS), complete IRB form in iRIS
    • New Submission
      • IRB Exempt Request - less than minimal risk and must meet one or more of the exempt categories
      • IRB Application - New Research (expedited or convened/full board)
        • Expedited - minimal risk and must meet one or more of the expedited review categories
        • Convened/Full - greater than minimal risk

 STEP 9 Upload/Attach any other study materials

  • Questionnaires, surveys, focus group guides, interview scripts, recruiting materials, flyers, translated documents, etc.

STEP 10  Submit to the IRB for Review

  • Convened/Full Board meets 1st and 3rd Tuesday of the month
    • New Submission 3 weeks prior to IRB meeting
  • Expedited
    • Submit any time, generally 7-10 working day turn-around time for determination
  • Exempt
    • Submit any time, generally 5-7 working day turn-around time for determination

For Questions contact:  Lori Scheller - IRB Administrator (ext. 93022)

See also: Investigator Resources - Human Subject Determinations and IRB Review page