IRB Library-Forms/Templates

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Form Description
IRB Protocol Form 

Template IRB protocol form for all levels of review. PIs should not delete or adjust the wording or numbering of any questions or sections. 

Click here for detailed guidance on how to respond to each question in the protocol.

Form A--Informed consent requirements

List of Requirements Lists all federally mandated guidelines for informed consent. To be used by PIs who want to write their own informed consent rather than using an approved template.

Click here for guidance on altering or waiving informed consent.

Form A—Informed consent for adult participants (18 or over) 

Template Contains all federally mandated guidelines. Must be edited for specific study. Mandatory for study participants 18 or over. Includes signature line for signed consent. A signed copy of Form A is kept in researcher's files; another copy is given to the study participant or person giving informed consent. 
Form A—Informed consent for adult participants (18 or over)--APPROVED SIGNATURE WAIVER

Template Contains all federally mandated guidelines. Must be edited for specific study. No signature line for participants. Mandatory for study participants 18 or over; does not include section for signature. A copy of Form A is given to the study participant.

Click here for guidance on waiving documentation of consent (i.e., waiving signed consent).

Form A—Informed consent for adult participants (18 or over)--FOR ONLINE STUDIES 

Template Contains all federally mandated guidelines. Must be edited for specific study. Mandatory for study participants 18 or over. No signature line but needs radio buttons to indicate consent or lack of consent unless signature waiver is approved. Form A—FOR ONLINE STUDIES can be copied and pasted into the online platform (e.g., Qualtrics).  It includes a request that study participants keep a copy for their files.

Click here for more guidance regarding online studies.

Form A—Informed consent for adult participants (18 or over)--FOR ONLINE STUDIES--APPROVED SIGNATURE WAIVER

Template Contains all federally mandated guidelines. Must be edited for specific study. Mandatory for study participants 18 or over. No signature line or radio buttons to indicate consent or lack of consent. Form A—FOR ONLINE STUDIES--APPROVED SIGNATURE WAIVER can be copied and pasted into the online platform (e.g., Qualtrics). It includes a request that study participants keep a copy for their files.

Click here for guidance on waiving documentation of consent (i.e., waiving signed consent).

Click here for more guidance regarding online studies.

Form A—Informed consent for parents/guardians of minors Template Contains all federally mandated guidelines. Must be edited for specific study. Mandatory for parents/guardians providing consent for minors to participate in a study. Includes signature line for signed consent. Can also be used for researchers to access identifiable student records per FERPA rules. A signed copy of Form A is kept in researcher's files; another copy is given to parents/guardians.
Form C—Statement of minor assent—elementary ExampleEdit or rewrite for specific study. For study participants under 18. Includes signature line for signed assent for children 5 or over. This example is for early elementary students. Kept in researcher's files. 
Form C—Statement of minor assent—middle grades Example Edit or rewrite for specific study. For study participants under 18. Includes signature line for signed assent. This example is for middle grades students. Kept in researcher's files. 
Form C—Statement of minor assent—high school Example Edit or rewrite for specific study. For study participants under 18. Includes signature line for signed assent. This example is for high school students. Kept in researcher's files. 
Form D—Research using specialized equipment Form Mandatory only if subject(s) will be using any equipment which might subject him/her to the possibility of accidental harm or injury.
Form E—Research involving psychological intervention Form Mandatory if subject(s) will be exposed to any psychological intervention, such as deception, contrived social situations, manipulation of the participant's attitudes, opinion or self-esteem, psychotherapeutic procedures, or other psychological influences.
Form F—Research involving physiological intervention Form Mandatory if subject(s) will be exposed to any physiological treatments or intervention upon the body by mechanical, electronic, chemical, biological or any other means.
Form G—Research involving deception Form Mandatory if subject(s) will be exposed to deception.
Form H—Letter of institutional support

Template Mandatory when working with a school, agency or other institution outside of The College at Brockport. Must be physically signed by supervisor or administrator and copied on that institution's letterhead, then scanned and submitted with proposal as a supporting document.

Often, institutions have their own template for this, but researchers may also use the one provided by the IRB. 

Form J—Advisor certification of responsibility for student researcher  Form Mandatory for all undergraduate or graduate students serving as Principal Investigators. Must be filled out and physically signed by project advisor, then scanned and submitted with proposal as a supporting document.

Form K—Project continuation and/or modification

Form Mandatory for all proposed changes to  or continuations for research protocols/proposals submitted before July 1, 2018. The only modifications that can be made to exempt projects are minor changes that do not affect the risk level. 

NOTE: Continuations and modifications for proposals submitted through the PACS system will not use this form. Submit continuations and modifications directly through PACS.

Form L—Close-Out Form

Mach Form Mandatory for all expedited and full board research protocols submitted before July 1, 2018. If all research-related interventions or interactions with human subjects have been completed and all data collection and analysis of identifiable private information described in the IRB-approved protocol has been finished, the human subjects research study has been completed and the investigator should close the study with the IRB by submitting Form L.

NOTE: Projects submitted through the PACS system will not use this form. 

Form M—Recruitment letter for adult participants (18 and over) 

Example Edit or rewrite for specific study. Necessary for most studies. Can also be presented as an e-mail, verbal script, or first page of an online study.

Click here for recruitment guidelines.

Form M—Recruitment letter for parents/guardians of minors)

Example Edit or rewrite for specific study. Necessary for most studies. Can also be presented as an e-mail, verbal script, or first page of an online study.

Click here for recruitment guidelines.

Form P--Reportable New Information (RNI) 

Template Mandatory if a research subject is affected by an adverse event or unexpected problem directly related to the research protocol. More information about Reportable New Information can be found here

NOTE: Projects submitted through the PACS system will not use this form. Instead, PIs will submit any Reportable New Information within the PACS system. 

Class Projects (research for university courses)

Link It is no longer necessary to fill out a form for classroom projects as long as they are primarily being used as a teaching tool. Click here for more specific guidelines about IRB oversight. Click here for Class Projects Best Practices.

Institutional Authorization Agreement (IAA)[Brockport as Institution of Record or Reviewer, aka Institution A]

Form A mandatory agreement signed by both The College at Brockport and another institution. Necessary if Brockport is providing IRB review for a co-sponsored project with another institution or organization.

Institutional Authorization Agreement (IAA) [Brockport as Relying Institution aka Institution B]

Form A mandatory agreement signed by both The College at Brockport and another institutionNecessary if another institution or organization is providing IRB review for a co-sponsored project.

Last Updated 9/7/18

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