IRB Request Form (PDF 159kB) - SUNY Empire State College

Revised 8/2010
06106—OAA
F-460—Rev. 9/2002
Institutional Review Board
Request for Approval of Research Using Human Subjects
This form serves as both a checklist and a request for information in relation to research using human
subjects. Research is defined as a systematic investigation designed to develop or contribute to
generalizable knowledge. It includes, but is not limited to, the procedures listed on page 3 of this form.
Human subjects are living people about or from whom information or data is collected. For the most
part, you will include the information requested within the proposal narrative. In a few places, we also
ask you to provide information directly on this form.
Name _____________________________________________________________________________________
Address____________________________________________________________________________________
City______________________________________State__________________ Zip Code__________________
E-mail Address ____________________________________________ Telephone________________________
Faculty Sponsor (for students) ____________________________ Center______________________________
Project Title ________________________________________________________________________________
Duration of Project from __________________ to __________________
Approval Requested from __________________ to __________________
(Maximum is for one year; must be renewed annually. Only two renewals will be granted. After three years, the project must be resubmitted.)
Project Description
Attach a research proposal that summarizes the purpose of the project in non-technical language, makes
the case for why the research ought to be done and addresses the information outlined below.
Subjects
1. In the proposal, describe the salient characteristics of the subjects including the age range, sex,
institutional affiliation and any other special criteria.
Indicate the number who will participate __________
Subject population (check all that apply)
■ adult
■ prisoner
■ disabled
■ minor
■ mentally disabled
■ physically ill
■ incapacitated
■ other (vulnerable population)
specify __________________________
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2. Explain the selection of special and/or vulnerable populations and, if there are alternatives, why they
are not being used. Explain how the rights and welfare of these special populations will be protected.
3. Explain how the subjects are to be recruited and what compensation, if any, is offered. Attach a copy
of the recruiting materials (letter, poster, advertisement).
4. If relevant, describe how permission has been obtained from cooperating institution(s) – school, prison
or other organization. For research within school districts, New York State law requires that the
superintendent of schools grant permission, not the principals. Attach the approval letters.
Informed Consent
1. In the proposal, describe how you will explain the research to the subjects and obtain their informed
consent to participate. If in writing, attach a copy of the consent form. If subjects are minors, or
otherwise not legally competent to consent, describe how assent is obtained from the subject and from
whom proxy consent is obtained. Indicate how the subjects are informed that they can quit the study
at any time.
A standard consent form should include the following items:
• Your name as the investigator and where you are from
• Contact information for investigator
• Description of the project (purpose/procedures)
• What is expected of the subjects
• Length of time their participation is required
• Location of the study
• A statement that participation is voluntary
• A statement that the subject can withdraw at any time or that the subject does not have to answer
any questions they don’t want to
• Payment, if any. Indicate amount and how to be paid
• Include referrals
• Include a risk/benefit statement. Note that risks to subjects can be physical, social, psychological,
legal or financial. If there are no anticipated risks, that should be stated.
• An explanation of how confidentiality or anonymity will be maintained
• Taping (if applicable) – provide a separate line for consenting to taping which should also include
information on how the tapes will be stored and disposed.
• The following human rights statement: If you have any questions concerning your rights as a
subject, contact Lorrie Anthony, Compliance Officer, Empire State College, One Union Avenue,
Saratoga Springs, NY 12866-4391; 518 587-2100 ext. 2358.
2. Assent form(s) for minors or other legally incompetent individuals, if appropriate must be attached.
They must be age appropriate, include all aspects of consent, with a statement that they do not have to
participate, even if their parents or legal guardians agreed. Parental consent must be obtained, using a
separate consent form, which must also be attached.
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Research Procedures
1. In the proposal, explain the procedures that relate to the subjects’ participation. Below, check all that
apply and attach requested information.
■ Questionnaires: submit a copy of all questionnaires including any cover page or introductory material.
■ Interviews: Provide a copy of the interview script or protocol. Describe the consent process and
attach consent forms or script.
■ Observation: Describe who and what you plan to observe. Explain any planned interaction with the
subjects. Attach permission letters from the observation site.
■ Taping: Describe planned procedures and how you will store and dispose of the tapes. Describe the
consent process and attach consent forms or script.
■ Records Review: Describe the medical or school records you will be reviewing and the data you will
be extracting from those records. Describe the consent process and attach consent forms. Attach
permission letters from appropriate officials.
■ Files: Define what information you will be extracting from files. Describe the consent process and
attach consent forms. Attach permission letters from appropriate officials.
■ Secondary Data Analysis: Describe the source of the information and explain if individuals are
identifiable in the data or if the information is identifiable through links, such as coded information
or pseudonyms. If identifiable, explain procedures to ensure confidentiality. Describe the consent
process and attach consent forms. Attach permission letters from appropriate officials.
■ Tasks: Provide details of the activity that will be expected of the subjects, and what you expect to
gain. Include the length of time the tasks will take. Describe any risks and how you intend to
minimize them. Describe the consent process and attach consent forms.
■ Tests or Other Instruments: Explain the nature of the tests or other measurement instruments.
Describe what information obtained from the instrument will be shared with the subject and when
applicable, procedures for referral. Describe the consent process and attach consent forms.
■ Treatment/Intervention: Give full details on the treatment process and if there are any alternatives to
be offered. Describe any risks and how you intend to minimize them. Describe the consent process
and attach consent forms.
■ Deception: You must provide convincing justification for deception. Describe the nature of the
deception and the significance to the subjects. Describe any consequent risk and how you plan to
minimize the risk. Discuss alternatives to the procedure and explain why have you not chosen an
alternate method. Describe the consent process and attach consent forms. Describe the debriefing
for subjects and tell when it will take place. The debriefing must clearly explain the deception, why
it was necessary and that the subjects still have the option of withdrawing their data.
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Risk/Benefit Analysis
1. In the proposal, describe any risk of any harm (physical, psychological, legal, social or financial) the
subjects may encounter as participants in this study. Explain why the risks are necessary. Explain what
you plan to do to minimize the risks. In the rare case that none are anticipated, state that.
2. Explain how participation in this study will benefit the subjects, the population and society.
3. Explain how the benefits will outweigh the risks. If the benefits do not outweigh the risks, even
minimal risks, the project will not be approved.
Confidentiality/Anonymity
In the proposal, explain how confidentiality or anonymity will be assured. Indicate when and how the
identifiers will be separated from the data and when the identifiers will be destroyed. If the identifiers are
to be retained, explain why.
Closing Down the Project
1. In the proposal, indicate if you will debrief your subjects or provide educational material after the
study. Attach copies of debriefing or educational materials.
2. Explain what will be done with the research data (written or otherwise recorded) at the end of the
study. If not destroyed, describe where, in what format and for how long the data will be stored.
Explain what uses — research, educational, demonstration, archiving — the data might be used for in
the future. Describe how subjects’ permission for further use of their data will be obtained.
Experience
1. Cite your experience and training for this kind of research. List any assistants who will be working
with you and cite their training and experience.
I certify that the information provided for this project is accurate, no other procedures will be used in
this project, and any modifications in this project will be submitted for approval prior to use.
Applicant Signature______________________________________________ Date_______________________
(principle investigator)
If the principle investigator is a student, the faculty sponsor (first reader) must also sign this form:
I have reviewed this completed application and I am satisfied with the adequacy of the proposed
research design and the measures proposed for the protection of human subjects. I certify that this
project is under my direct supervision and that I am responsible for ensuring that the investigator
complies with all of the provisions of approval.
Faculty Sponsor Signature_________________________________________ Date______________________
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Submission Instructions
Graduate students must submit this form with their final project proposal to their mentor. All final
projects require the signature/approval of your mentor, the program chair, and the dean of graduate
studies. Further, the dean of graduate studies is a member of the IRB and is authorized to conduct
expedited reviews. The dean of graduate studies will forward graduate student projects requiring further
review to the IRB chair.
All others, including undergraduate students return the application with the requested attachments to:
Chair, Institutional Review Board
Office of Academic Affairs
Empire State College
One Union Avenue
Saratoga Springs, NY 12866-4391
Faculty and students must obtain written approval from the IRB before beginning research.
Submission Checklist
■ Signed request form
■ Research proposal
■ Recruitment letter, poster, advertisement
■ Written consent form (or script) and assent form
■ Tests or other psychological instruments
■ Surveys, questionnaires or interview scripts or protocols
■ Subject instructions
■ Educational or debriefing materials
■ Other institutional approvals/permissions
IRB Approval
Expedited Review
■ Approved through expedited review
■ Referral for full IRB review
Review by Full IRB
■ Approved with full committee review
■ No approval granted (see attached)
IRB Representative ____________________________
Signature____________________________________
Date _______________________________________
IRB Chair_________________________________
Signature__________________________________
Date _____________________________________
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