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Table of Contents Slide
IRB Submission Process and eProtocol Resources 2‐3
Request eProtocol User ID 4
eProtocol Log in 5
Create/Clone/Delete Protocol 6
Personnel 7‐8
Popula on checklist 9
Study loca on and Le ers of support 10
Funding 11
General Checklist: includes “eligible for exempt review” 12
Exempt categories 13‐14
Expedited categories 15‐17
Study tle, objec ves, research ques on 18
Study procedures and background 19
Inves gator experience 20
Subject popula on 21
Subject compensa on and costs 22
Recruitment and Poten al benefits to par cipants 23
Risks 24
Confiden ality of data 25‐26
Provisions to protect privacy 27
Poten al conflicts of interest 28
Consent/Assent 29‐31
HIPAA 32
A achments 33
Check for completeness 34
Obliga ons 35
Event History 36
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https://usm.maine.edu/orio/new-protocols
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DO NOT HIT THE BACK BUTTON on your browser
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‐The first PI is always filled in with profile informa on. Everyone else is added by clicking on the binoculars icon.
‐Refer to slide #2; each person must be in eProtocol in order to add them to a protocol. CITI training must be up to date.
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Only the Primary Inves gator’s CITI training date is entered automa cally from their profile; others are manually entered.
Dates are verified either by associa on in CITI with the University of Maine System or by providing USM IRB with a CITI Report (not cer ficate) which lists courses taken within a module. Modules can vary by ins tu on.
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When using a sample of convenience, such as your colleagues or fellow students, you MUST separate yourself from that role.
You are approaching as a student. You may need permission to use resources available to you and avoid the percep on of coercion.
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To ensure a research site has given permission for inves gators to recruit subjects or conduct research, a le er of support may be required (not re‐quired if USM is the research site). If a contract, coopera ve agreement or Memorandum of Understanding (MOU) exists between the research site and USM for the research, a le er of support is not required.
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Adding funding a sources in eProtocol is a li le redundant.
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USM policy states ORIO reviews Exempt Categories.
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1a. This statement is reported every month to the en re IRB. This is an overview statement of your research.
1b. What is your research hypotheses, what are you trying to prove/disprove, what are you trying to accomplish by conduc ng this research?
Note: A ach survey ques ons or research variables in the a achment sec on.
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2a Ac vi es: e.g. comple ng a survey, taking a test, answering ques ons in an interview, comple ng a specific task, running on a treadmill, etc.
You may also state using secondary data.
2c. Decep on: Research in which the subject is inten onally deceived about research par cipa on.
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6c. Dura on: e.g. par cipants will spend two hours in an interview. This is a two year study.
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8a. Recruitment Materials: e.g. le ers, flyers, adver sements, scripts for verbal recruitment, etc.
9a: Benefits: Something of posi ve value to health and welfare.
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10a. Include safety precau ons you are taking for yourself e.g. mee ng interviewees in a public place or in tandem with a support person.
As defined at 45 C.F.R. § 46.102(i), “Minimal risk means that the probability and magnitude of harm or discomfort an cipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of rou ne physical or psychological examina ons or tests.”
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11a. Be explicate in your descrip on.
If an on line survey, what pla orm do you intend to use?
Consider: How will consent form be available for an on line survey?
‐How is data collected and transferred for analysis
‐Who is collec ng and has access to the data
‐Where is data being stored, describe security
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Consent templates: h p://usm.maine.edu/orio/informed‐consent.
If using de‐iden fied secondary data, where consent is not required, you may upload a blank document; however, there a ques ons to answer. See next slide.
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Pop up box for consent documents. Add one at a me if mul ple. Answer the ques ons for each consent form.
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If you check “children” on the Popula on Checklist tab, Assent Add will be available.
Child Assent and Parental Permission templates and guidance: h ps://usm.maine.edu/orio/child‐assentparental‐permission‐guidance
“Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (45 CFR 46.402(b)). This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. When judging whether children are capable of assent, the Institutional Review Board (IRB) is charged with taking into account the ages, maturity, and psychological state of the children involved. The IRB has the discretion to judge children’s capacity to assent for all of the children to be involved in a proposed research activity, or on an individual basis. h ps://www.hhs.gov/ohrp/regula ons‐and‐policy/guidance/faq/children‐research/index.html
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* * * ! * * *
One of the most common reasons a protocol is sent back before it is sent to the IRB is for missing a achments.
‐Resume/CV for everyone
‐Recruitment materials/scripts
‐Le er of permission from a loca on
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You can click on any line of the “check for completeness” pop up to be brought to that sec on for edits.
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Open in EDIT mode to see the Submit bu on.
If there is no faculty advisor (FA) listed in Personnel, FA will not be necessary. However, if you are a student there MUST be a faculty advisor.
If FA is in Personnel, the protocol will go into their que for review. The FA submits it to the IRB.
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Event History is helpful to know where your protocol is at in the review process.
“Cycle” means the IRB reviewer has submi ed comments.