Institutional Review Board (IRB) Office of Regulatory & Research Compliance (ORRC) University at Albany, MSC 309 (Phone) 518-437-3850 (Fax) 518-437-3855 (E-mail) irb@albany.edu Date Received ORRC Assigned : JG ___ TR ___ AB___ Date: _______________ Submission # Date of determination: ________________ Version 11.01.13.01 Submit, via mail or hand delivery, one complete, signed protocol package with all attachments. Annual Continuing Review Request Form Principal Investigator(s): Protocol Number: Protocol Title: Protocol Expiration Date: Campus Address : E-mail (must be UAlbany domain email address) : DO NOT LEAVE ANY QUESTIONS BLANK, INDICATE N/A WHEN NECESSARY 1. Protocol Status (Check One): Research Not Started No participants have been enrolled. Check one: Participant recruitment, enrollment and inteactions are on-going Protocol is Active – Work in Progress Recruitment through Psychology 101 Research Pool? Yes No Enrollment closed, but subjects are still undergoing study procedures Data analysis of IDENTIFIABLE data only STOP! Complete “IRB Closure Request Form” instead of this form Work Completed (LINK) IRB Closure Request Form. Work on Protocol Will Not Be Done STOP! Complete “IRB Closure Request Form” instead of this form (LINK) IRB Closure Request Form 1. For all active protocols in which participant enrollment is on-going, please include one copy of your current consent form(s). Consent Form(s) attached (CLEAN ORIGINAL) Not Applicable PLEASE NOTE: If you are required to submit a “clean” copy of your current consent form, please replace your existing human rights statement with the following: IRB contact about your rights in the study or to report a complaint: Research at the University Albany involving human participants is carried out under the oversight of the Institutional Review Board (IRB). This research has been reviewed and approved by the IRB. If you have any questions concerning your rights as a research subject or if you wish to report any concerns about the study, you may contact University at Albany Office of Regulatory & Research Compliance at 1-866-857-5459 or hsconcerns@albany.edu. OR (if applicable) For Parental/LAR consent forms: IRB contact about your rights in the study or to report a complaint: Research at the University Albany involving human participants is carried out under the oversight of the Institutional Review Board (IRB). This research has been reviewed and approved by the IRB. If you have any 1 questions concerning your (child’s, parent’s, etc.) rights as a research subject or if you wish to report any concerns about the study, you may contact University at Albany Office of Regulatory & Research Compliance at 1-866-8575459 or hsconcerns@albany.edu. 2. For sponsored research (e.g., grant funded) report all changes that have been made or will be made to the sponsor application or award related to the use of human subjects. Submit 1 copy of the revised grant information with the relevant human subject sections highlighted. Not Applicable Application/Grant has NOT been revised Grant revision is attached 3. If your research has not yet started, provide reason for the delay and skip down to item # 11. 4. Provide the following information for research involving human subjects for the current approval period. A. The number of participants approved for this research study: B. The number of participants enrolled to date (completed informed consent process): C. The number of participants who withdrew or discontinued participation in the research to date: D. The number of participants who completed the study: E. Have any participants become incarcerated? Yes No If yes, include number 5. Provide a brief summary of the work completed so far. 6. A brief summary of any amendments or modifications to the research since your last IRB approval: None 7. A summary of any adverse events or unanticipated problems that were possibly related to participation in this research. None 8. A summary of the reasons for participant withdrawal and any complaints about the research since the last IRB review. None 9. A summary of any relevant literature, interim findings, etc. affecting the risk/benefit ratio of this study: 10. Are you aware of any new findings that may relate to the participant’s willingness to continue in this research project? If so, describe: 11. Were any unexpected benefits to the subjects discovered during this review period? PRINCIPAL INVESTIGATOR ASSURANCE: By signing this form you are acknowledging the following: 2 You certify that all submitted statements about this research study are true and accurate. You will conduct this study in strict accordance with all submitted statements except where a change is necessary to eliminate an immediate hazard to a research participant. You will report all intended changes in previously approved research prior to implementation. You will maintain accurate and complete records of research data. You will conduct the research in compliance with University at Albany Policies, federal, state and local laws, Declaration of Helsinki and the Belmont Report. You will report all adverse events within 10 calendar days of the occurrence to the Office of Research Compliance. If you have obtained funding for this research, you will submit all changes in research that have been made to the sponsor’s funding application which relate to human subjects within 30 calendar day to the Office of Regulatory & Research Compliance. If you are a student principal investigator, you are responsible for obtaining review and approval for this continuing review from your faculty advisor. If you are a student principal investigator, you are responsible for obtaining review and approval for this continuing review from your faculty advisor. Principal Investigator Certification: As PRINCIPAL INVESTIGATOR, I certify that the information provided above is accurate and complete to the best of my knowledge. As principal investigator, I have ultimate responsibility for the conduct of this study, the ethical performance of the project, the protection of the rights and welfare of human subjects and strict adherence to any stipulations designated by the IRB. I agree to comply with all UAlbany policies and procedures, as well as with all applicable Federal, State and local laws regarding the protection of human subjects in research. _____________________________________________ Principal Investigator Signature Printed Name: _________________ Date 12. FACULTY ADVISOR ASSURANCE (if applicable; required when PI is a student) - By signing this form you are acknowledging the following: You have reviewed and approved the information reported on this form. You will oversee the conduct of the research for compliance with University at Albany Policies, federal, state and local laws, Declaration of Helsinki and the Belmont Report and will promptly report any deviations to the Office of Regulatory & Research Compliance. Faculty Advisor Certification: As FACULTY ADVISOR of the student investigator, I certify that I understand that it is my responsibility to: Review and determine that the student’s research project has scientific merit and that the student has the necessary resources to complete the project and achieve its goals; ensure that the student researcher is properly training in the protection of research participants and the ethical conduct of research; ensure that the student researcher obtains IRB approval for the research study and for any subsequent modifications; ensure that the research is performed according to ethical principles and in compliance with all applicable regulations and in accordance with University at Albany policies and procedures. _____________________________________________ _________________ Faculty Advisor Signature Printed Name: Date 3