HOUSEKEEPING
IRB Meeting Dates
Please submit protocols for IRB review 2 1/2 weeks prior to desired review date. Protocols should be submitted to the Office of Sponsored Programs, HAB 805.
POLICIES, PROCEDURES and PRINCIPLES
SUNY New Paltz Policy on the Use of Human Subjects in Research (updated 2/1/06) *
Determinations by Chair of Not Human Subject Research * (updated 9/7/07)
Guidelines for Student Research Activities *
External Researcher Approval Procedure *
Human Subject Education Requirements for Investigators and Project Team (revised 1-12-04)*
The Belmont Report *
Ethical principles and guidelines for the protection of human subjects in research
Protection of Human Subjects - 45 CFR 46
Federal Policy on the protection of human subjects in research
GUIDANCE
Determining the Need for IRB Review from Definitions and Scenarios *
Determining whether your research is human subjectresearch(includesMeta-analysis and Pre-existing Data Scenarios).
Engagement of Institutions in Research *
MANUALS AND FORMS
Application Manual
SUNY New Paltz Institutional Review Board Application Manual *
Handbook for submission of protocols to the IRB for review and approval.
(see Forms for Investigators below for electronic versions of the IRB forms)
Forms for Investigators
Please note that the Word forms may be completed and saved within Word
- Informed Consent *
- IRB Consent Form Checklist [PDF * or Word]
- Application for Research Proposal Review [PDF* or Word]
- Research Proposal Checklist [PDF* or Word]
- Application for Survey Research Exemption [PDF* or Word]
- Survey Research Proposal Checklist [PDF* or Word]
- Application for Modification Approval [PDF* or Word]
- Application for Continued Approval/Final Report [PDF* or Word]
- Video Documentary Interview Release Form *
- Sample Assent Form *
- Exempt Research Categories
- Expedited Research Categories
- International Research [PDF* or Word]
Forms for IRB Members
- Research Proposal Checklist [PDF* or Word]
- Survey Research Proposal Checklist [PDF* or Word]
- IRB Consent Form Checklist [PDF * or Word]
- 7A-7E Decisions [PDF * or Word]
- Cover Letter for Checklist [PDF * or Word]
- Exempt Research Categories
- Expedited Research Categories
- Online Review Process *
HIPAA
- SUNY New Paltz Policy and Procedure on Research Subjects' Right to Privacy *
- HIPAA Introduction *
- Model Forms for Use by Covered Entities *
- HIPAA Authorization - Instructions for Preparing Consent Documents for HIPAA Compliance *
- Attachment A* - What about Confidentiality of Records and Authorization to Use/Share Protected Health Information for Research?
- Attachment B* - Consent Language for Banking Specimens or Voice/Fingerprints in Research
- Attachment C* - Consent to Participate in Research & Authorization to Use and Share Personal Health Information
- Attachment D* - Consent to Participate in Research & Authorization to Use and Share Personal Health Information (for subjects 18 years of age and older)
- Attachment E* - Consent to Participate in Research & Authorization to Use and Share Personal Health Information (for subjects less than 18 years of age)
- Application for HIPAA Waiver of Authorization *
- HIPAA De-Identification Certification Form *
- Limited Data Set (LDS) Request Form *
- Model Data Use Agreement
- Model Request for Permission to Access Identifiable Health Information of Deceased Individuals *
- Model Request for Permission to Access Identifiable Health Information for Reviews Preparatory to Research *
EDUCATION REQUIREMENTS
SUNY New Paltz uses the online Collaborative IRB Training Initiative (CITI) to satisfy compliance with Federal human subject education requirements.
Collaborative IRB Training Initiative
Instructions:
Follow the link to www.citiprogram.org.
- Register for the course by selecting your institutional affiliation (State University of New York - New Paltz) and establishing a training username, password and profile.
- Choose "Social/Behavioral Research"
- For investigators who have never taken a human subject education course or who need to renew a non-CITI human subject education certification, answer "no" when asked about your Previous Basic CITI Course Completion. Complete the required modules and any optional modules that may be relevant to your human subjects research.
- For Investigators who are re-validating their original Basic CITI training, answer "yes" when asked about your Previous Basic CITI Completion, then complete the required modules in the "Refresher Course."
- Upon course completion, download a copy of your transcript.
A passing score of 70% is required to earn a training certificate.
When you download a copy of your transcript, your grades will be automatically forwarded to the SUNY New Paltz Office of Sponsored Programs where a certificate of completion will be issued. This certificate will be mailed to the address you provided upon login to the CITI Course. One copy will be retained in the Sponsored Programs office for federal audit purposes.
You must include a copy of this certificate with any application you submit to the SUNY New Paltz Institutional Review Board (IRB). No human subjects research can be approved by the IRB until the investigator submits documentation certifying completion of an approved protection of human research subjects training program.
