table of contents slide irb submission process and ......table of contents slide ... study tle,...

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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 

Subject checklist  9 

Study loca on and Le ers of support  10 

General Checklist: includes “eligible for exempt review”  11 

Funding  12 

Exempt/Expedited  13 

Exempt Categories   14‐17 

Study  tle, Summary, Purpose, Procedures  21‐22 

Study procedures and background  23 

Subject Popula on  24‐25 

Recruitment Process, Subject Compensa on  26‐27 

Risks and Benefits  28 

Procedures to Maintain Confiden ality  29‐30 

Consent forms  31‐41 

Assent forms  31, 42‐47 

Health Insurance Portability and Accountability Act (HIPAA)  48 

Drugs and Devices  49 

Poten al Conflicts of Interest  50 

A achments  51 

Obliga ons  52 

Check for Completeness and Submit form  53 

Print as pdf  54 

Event History  55 

Expedited Categories  15‐20 

Updated 10/31/2019 

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https://usm.maine.edu/orio/new-protocols

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DO NOT HIT THE BACK BUTTON

Click Create Protocol bu on.  

Enter your  tle, even if a temporary  tle.  

Click IRB Form 

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Once you click the IRB Form bu on, the Personnel sec on will show.  

Click the Create bu on which will take you to Personnel within the protocol. 

Fill in your CITI training date.  

Update any exis ng informa on as needed. 

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Click the binoculars icon to select a name. If they are not in the list, then they may not be in eProtocol.  

Fill in each persons CITI training informa on. 

Request an eProtocol ID: h p://usm.maine.edu/orio/request‐e‐protocol‐user‐id  

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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.  

Certain features are not available based on selec ons. For example, if you do not check Children, uploading an Assent form will not be available in a later sec on. 

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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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Skip if none. 

Add bu on creates a pop up. 

Adding funding a sources. 

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USM policy states ORIO reviews Exempt Categories.  

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Procedures 3. a‐e

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Procedures 3. Con nued

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10. Procedures to Maintain Confidentiality a-i

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 10. Procedures to Maintain Confidentiality a-i

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10/31/2019

ORIO is evaluating the set up of Consent and Assent in eProtocol with Key Solutions.

The following slides provides some guidance as to what questions go with what type of consent/assent.

Please contact ORIO with any questions: usmorio@maine.edu 207-780-4517

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Informed Consent and Broad Consent: All research subjects will be completely informed regarding aspects of the study. Signature required. Parental Permission: Parents or legally authorized representatives of the research subjects will be completely informed regarding aspects of the study. Waiver of Documentation of Informed Consent: -An IRB may waive the requirement for an investigator to obtain a signed consent form for some or all subjects. -Potential participants are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB. Waiver of Documentation of Parental Permission: An IRB may waive the requirement for an investigator to obtain a signed consent form Parents or legally authorized representatives. Parents or legally authorized representatives are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB. Alternation of Informed Consent: An IRB may approve a consent procedure, which alters some of the elements of informed consent. An Informed Assent is in addition to the Parental Permission. Waiver of Informed Consent: An IRB may approve a consent procedure, which does not include all of the elements of informed consent. Alteration of Parental Permission: An IRB may approve a consent procedure, which alters some of the elements of informed consent. Waiver of Parental Permission: An IRB may waive the requirement to obtain documentation of parental permission (waiver of consent). Informed Consent Checklist: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html Templates: https://usm.maine.edu/orio/informed-consent

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Address the following points. A Yes/No Response is not adequate.  

Informed Consent and Broad Consent: All research subjects will be completely informed regarding aspects of the study. Signature required.

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Parental Permission: Parents or legally authorized representatives of the research subjects will be completely informed regarding aspects of the study.

Address the following points. A Yes/No Response is not adequate.  

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Waiver of Documentation of Informed Consent: -An IRB may waive the requirement for an investigator to obtain a signed consent form for some or all subjects. -Potential participants are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

Address the following points. A Yes/No Response is not adequate.  

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Alternation of Informed Consent: Continued

AND 

In the A achments sec on, a ach a copy of the debriefing script you will use.  

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Waiver of Documentation of Parental Permission: An IRB may waive the requirement for an investigator to obtain a signed consent form Parents or legally authorized representatives. Parents or legally authorized representatives are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

Address the following points. A Yes/No Response is not adequate.  

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Alternation of Informed Consent: An IRB may approve a consent procedure, which alters some of the elements of informed consent. An Informed Assent is in addition to the Parental Permission.

Address the following points. A Yes/No Response is not adequate.  

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Waiver of Informed Consent: An IRB may approve a consent procedure, which does not include all of the elements of informed consent.

The waiver of consent will not adversely affect the rights and welfare of the subjects. (Yes/No) (text box)  

AND 

In the A achments sec on, a ach a copy of the debriefing script you will use.  

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Alteration of Parental Permission: An IRB may approve a consent procedure, which alters some of the elements of informed consent.

Address the following points. A Yes/No Response is not adequate.  

Alteration of Parental Permission: continued

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Alteration of Parental Permission: continued

Waiver of Parental Permission: An IRB may waive the requirement to obtain documentation of parental permission (waiver of consent).

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Informed Assent: All child research subjects will be completely informed regarding aspects of the study. Assent is in addition to Parental Permission/Informed Consent. Signature required. Waiver of Documentation of Informed Assent: -An IRB may waive the requirement for an investigator to obtain a signed assent form for some or all subjects. -Potential participants are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

Alteration of Informed Assent: An IRB may approve an assent procedure, which alters some of the elements of informed assent. Waiver of Informed Assent: An IRB may waive the requirement to obtain documentation of informed assent (waiver of assent). Informed Assent and Parental Permission Guidance: https://usm.maine.edu/orio/child-assentparental-permission-guidance

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Informed Assent: All child research subjects will be completely informed regarding aspects of the study. Assent is in addition to Parental Permission/Informed Consent. Signature required.

Address the following points. A Yes/No Response is not adequate.  

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Waiver of Documentation of Informed Assent: -An IRB may waive the requirement for an investigator to obtain a signed assent form for some or all subjects. -Potential participants are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

Address the following points. A Yes/No Response is not adequate.  

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Alternation of Informed Assent: An IRB may waive the requirement to obtain documentation of informed assent (waiver of assent).

Address the following points. A Yes/No Response is not adequate.  

Alternation of Informed Assent: continued

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Alternation of Informed Assent: continued

Address the following points. A Yes/No Response is not adequate.  

AND 

In the A achments sec on, a ach a copy of the debriefing script you will use.  

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Waiver of Informed Assent: An IRB may approve an assent procedure, which alters some of the elements of informed assent.

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Once the Student PI submits the protocol, it goes into the listed Faculty Advisors que for review. The FA clicks their part of the Obliga ons, then submits the protocol to the IRB. 

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Check for Completeness

Submit Form button on the left

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Option of “printing” as a pdf

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