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
- New Submission
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
- Submit any time, generally 7-10 working day turn-around time for determination
- 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