To edit the following documents, download and save them to your own device.
If you have any questions related to these forms, our FAQ webpage may have the answer. If you have any questions not answered in the FAQ or on this webpage, email the IRB Compliance Officer.
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.
- All PIs must complete the Group 2 portion.
- Faculty, staff, and graduate and undergraduate students must complete the Human Research CITI course.
- All student PIs must also complete the Students in Research module.
Quiz scores for CITI modules must be at least 80% in order to be considered complete.
Form A
INFORMED CONSENT REQUIREMENTS
Lists all federally mandated guidelines for informed consent. These can 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.
INFORMED CONSENT FOR ADULT PARTICIPANTS (18 OR OLDER)
This 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.
INFORMED CONSENT FOR ADULT PARTICIPANTS (18 OR OLDER) APPROVED SIGNATURE WAIVER
This 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)
INFORMED CONSENT FOR ADULT PARTICIPANTS (18 OR OLDER) FOR ONLINE STUDIES
This 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
This form 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.
INFORMED CONSENT FOR ADULT PARTICIPANTS (18 OR OLDER) FOR ONLINE STUDIES—APPROVED SIGNATURE WAIVER
This 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
This form 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).
INFORMED CONSENT FOR PARENTS/GUARDIANS OF MINORS
This 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
This is only an example for elementary school students. Edit or rewrite this document for your specific study. This document should be kept in the researchers files.
- For study participants under 18.
- Includes signature line for signed assent for children 5 or over.
STATEMENT OF MINOR ASSENT—MIDDLE GRADES
This is only an example for middle grade students. Edit or rewrite this document for your specific study. This document should be kept in the researchers files.
- For study participants under 18.
- Includes signature line for signed assent.
STATEMENT OF MINOR ASSENT—HIGH SCHOOL
This is only an example for high school students. Edit or rewrite this document for your specific study. This document should be kept in the researchers files.
- For study participants under 18
- Includes signature line for signed assent
Form D—Research Involving Specialized Equipment
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
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
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
Mandatory if subject(s) will be exposed to deception
Form H—Letter of Institutional Support
Mandatory when working with a school, agency, or other institution outside of SUNY 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
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
Mandatory for all proposed changes to or continuations for research protocols/proposals submitted prior to July 1, 2018. The only modifications that can be made to exempt projects are minor changes that do not affect the risk level.
Form L—Close-Out Form
This MachForm is 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, then 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 OLDER)
This is only and example. Edit or rewrite this document for your specific study.
- Necessary for most studies
- Can also be presented as an e-mail, verbal script, or first page of an online study
RECRUITMENT LETTER FOR PARENTS/GUARDIANS OF MINORS
This is only an example. Edit or rewrite this document for your specific study.
- Necessary for most studies
- Can also be presented as an e-mail, verbal script, or first page of an online study
Form P—Reportable New Information (RNI)
Mandatory if a research subject is affected by an adverse event or unexpected problem directly related to the research protocol.
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)
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. See our FAQ for more information
Institutional Authorization Agreement (IAA)
BROCKPORT AS INSTITUTION OF RECORD OR REVIEWER AKA INSTITUTION A
A mandatory agreement signed by both SUNY Brockport and another institution. Necessary if Brockport is providing IRB review for a co-sponsored project with another institution or organization.
BROCKPORT AS RELYING INSTITUTION AKA INSTITUTION B
A mandatory agreement signed by both SUNY Brockport and another institution. Necessary if another institution or organization is providing IRB review for a co-sponsored project.