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Search The Office of Regulatory Research compliance

 

 

 


Office of Regulatory Research Compliance
 

 

FORMS

 

 

 

IRB FORMS

New IRB forms are now available. Old versions of forms will not be accepted after 9/30/09.

(For Research Involving Human Subjects)
All forms are designed to be completed electronically. After completion, the form should be printed, signed and mailed or delivered to the Office of Regulatory Research Compliance, LCSB 28.
Form Title

Download Format

Please note: The Primary Protocol Review Form is required for all submissions and will indicate additional forms that may also be required.
New Research Primary Protocol Submission Form Word** RTF

 

Supplemental Forms That May Be Required
#1 Research Involving Minors (Children Under the Age of 18) Word RTF
#2 Biomedical Research (Involving Invasive Procedures) Word RTF
#3 Research Involving the Use of Focus Groups Word RTF
#4 Research Involving Human Tissue Samples Word RTF
#5 Research Involving Deception Word RTF
#6 Research Conducted on UAlbany Campus or in a UAlbany Classroom Word RTF
#7

Research Involving Off-Campus Research Sites (Non-UAlbany)

Word RTF
#8 International Research Word RTF
#9 Research Involving Sensitive Topics such as Sexual Behavior, Illegal Conduct, HIV/AIDS Status, Genetic Information, Alcohol Use or Other Sensitive Topics Word RTF
#10 Research Involving the Use of Secondary/Existing Data Word RTF
#11 Oral History or Ethnographic/Naturalistic Research Word RTF
#12 Research Involving the Use of Experimental Equipment with Subjects (not audio or video tapes) Word RTF
#13 Research Involving the Use of Psychology 101 Participants Word RTF
#14 Research Involving a Collaborating Organization/Group/Investigator Word RTF

 

Forms That May Be Required for Exempt Review

One of these forms should accompany the New Primary Protocol Form above.

Exempt Category 1

Research Involving Education Strategies, Curricula or Classroom Management Methods

Word RTF

Exempt Category 2

Research Involving the Use of Tests, Surveys, Interviews or Observations

Word RTF

Exempt Category 3

Research Involving Elected or Appointed Officials or Conducted under Federal Statute

Word RTF

Exempt Category 4

Research Involving the Use of Secondary Existing Data, Documents, Records Review and Pathological Specimens

Word RTF

 

Additional ORRC Forms
Form Title: Download Format
Request for Modification to Approved Research Word RTF

Use this form to submit a change to an approved IRB research protocol.

ALL changes to an approved IRB research protocol must be submitted to the IRB for review and approval before changes are implemented.

Request for Continuing Review Word RTF

Use this form to submit study information necessary to maintain IRB approval.

IRB approval must be maintained for the entire duration of your research project. Approval must be renewed on an annual basis. You may request 4 continuations before a new protocol must be submitted.

IRB Closure Request Form Word RTF
Individual Investigator's Agreement Word RTF

Use this form with unaffiliated collaborating non-UAlbany investigators.

This form is required when research is being conducted under the direction and supervision of a principal investigator from UAlbany in the following 2 scenarios:

(1) Collaborating independent investigators (i.e. not acting as an employee of any institution with respect to their involvement in the research being conducted by UAlbany)

(2) Collaborating institutional investigators (i.e. acting as an employee or agent of a institution with respect to their involvement in the research being conducted by UAlbany if the institution

a) does not hold a Federal Wide Assurance AND

b) does not routinely conduct human subjects research

Refer to the following link for additional information:

Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement

Adverse/Unanticipated Event Report

Use this form to report ANY study-related adverse/unanticipated event

Adverse/unanticipated events must be submitted within 10 days of their occurrence.

Word RTF

IRB Screening Form

Use this form when you are unsure if your research project requires IRB review.

This form will be evaluated to determine if your research project requires IRB review.

Word RTF

Addition/Deletion of Study Personnel

Use this form when study personnel changes occur to an approved research project with no other modifications.

IRB approval must be obtained before additional personnel may participate in the research.

Word RTF

Investigator Checklist

Use this form when submitting your new IRB research protocol to determine if application is complete.

Incomplete applications will not be reviewed and will be returned to you without processing.

Submission of this form is NOT required.

Word RTF

 

ORRC Templates

Informed Consent Template A

Use template when preparing a consent form FOR NON-EXEMPT RESEARCH

The researcher should prepare their consent form in language that is "user-friendly" for their research population

Word RTF

Informed Consent Template B

Use this template when conducting an EXEMPT RESEARCH PROJECT WITH ADULTS

The researcher should evaluate the applicability of the template to their research proposal. This form will not "fit" ALL exempt research studies

Word RTF

 

 

 

 

 

IACUC FORMS

New IACUC forms are now available. Old versions of forms will not be accepted after 9/30/09.

(For Reseach Involving Animal Subjects)
All forms are designed to be completed electronically. After completion, the form should be printed, signed and mailed or delivered to the Office of Regulatory Research Compliance, LCSB 28.

 

Form Title

Download Format

Please note: The Primary Protocol Review Form is required for all submissions and will indicate additional forms that may also be required.
Primary IACUC/IBC Form RTF

 

          Supplemental Forms That May Be Required
          #1 Collection or Receipt of Biological Samples Word RTF
          #2 Behavioral Testing Word RTF
          #3 Pain or Distress to Animals Word RTF
          #4 Drug Administration Word RTF
          #5 Biological Toxin Administration Word RTF
          #6 Surgery Word RTF
          #7 Alternative Housing Request Word RTF
          #8 Breeding Colony (Establishment and Maintenance) Word RTF

           

          Additional IACUC Forms
          Form Title: Download Format
          Request for Modification to Approved Research Word RTF

          Use this form to submit a change to an approved IACUC research protocol.

          ALL changes to an approved IACUC research protocol must be submitted to the IACUC for review and approval before changes are implemented.

          IACUC Annual Approval Continuation Request Word RTF

          Use this form to submit study information necessary to maintain IACUC approval.

          IACUC approval must be maintained for the entire duration of your research project. Approval must be renewed on an annual basis.

          Study Closure Form Word RTF

           

             

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IBC FORMS

(For Research Involving Biohazardous Materials)

All forms are designed to be completed electronically. After completion, the form should be printed, signed and mailed or delivered to the Office of Regulatory Research Compliance, LCSB 28.

 

Form Title

Download Format

Please note: The Primary Protocol Review Form is required for all submissions and will indicate additional forms that may also be required.
Primary IACUC/IBC Form RTF
Schedule B: Biohazards Form RTF
Schedule C: Human Tissues Form RTF
IRB Supplemental Form #4-Research Involving Human Tissue Samples (complete when submitting Schedule C above) Word RTF

 

 

 

 

 


University at Albany
Office for Regulatory Research Compliance
Lecture Center Sub-Basement, Room 28
1400 Washington Avenue
Albany, NY 12222

Email: orrc@uamail.albany.edu
Telephone: (518) 442-9050
Fax: (518) 442-9997

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