Protocol modification

University of North Carolina at Asheville

INSTITUTIONAL REVIEW BOARD (IRB)

FOR THE PROTECTION OF HUMAN SUBJECTS

Protocol Modification, Continuing Review, or Final Report Form
(Form B)

Human subject protocols are generally approved by the IRB for a twelve-month period. The responsible Project Investigator (PI) is required to report all proposed modifications to the protocol and/or the informed consent form to the IRB during the approval period, and the IRB must approve these modifications prior to their implementation. Federal regulations also require a continuing review for ongoing projects no less than annually. Finally, if the project is concluded, the PI must file a final report with the IRB. Please complete this form for any of these actions, obtain appropriate signatures, and return the form to the current Chair of the UNCA IRB.

PLEASE CHECK ALL APPROPRIATE BOXES, FILL IN ALL BLANKS,
AND ANSWER ALL APPLICABLE QUESTIONS COMPLETELY.

THIS FORM IS BEING SUBMITTED FOR THE FOLLOWING PURPOSE(S):

__ Protocol Modification       AND/OR __ Continuing (Annual)Review     OR __ Final Report

(complete parts A, C, & F) (complete parts A, B, D, & F) (complete parts A, B, E, & F)

PART A (For ALL REPORTS)

Principal Investigator:     Department:    Telephone:

________________________________________ ____________________________ _____________________

Project Title:

___________________________________________________________________________________________

Initial Risk Determination:            __ Minimal                                         __ More than Minimal

Original Approval Date: __________________

PART B (For CONTINUING REVIEW and FINAL REPORT ONLY)

Number of subjects approved for inclusion in the study:
(Refer to your original application or most recent modification approval .) ________

Total number of subjects enrolled in the study to date: ________


Do you plan to enroll additional subjects in this study?     __ Yes      __ No        If "YES," how many? _______

PART C (For PROTOCOL MODIFICATION ONLY). Attach a statement (maximum 2 pages) that addresses the following, as needed:

1. Description of MINOR CHANGES proposed (includes changes in project title, principal investigator(s), co-investigator(s), location of the study, and data analysis and/or reporting procedures).

2. Description of MAJOR CHANGES proposed (includes changes in purpose of the study, duration of the study, subject population, subject recruitment procedures, number of subjects [including controls], costs and/or compensation to subjects, voluntary participation, experimental procedures, alternate procedures, procedures for maintaining confidentiality, and/or consent procedures [including changes to the consent form].

3. Discussion of unanticipated risks or new information that may affect the risk/benefit assessment, if applicable.

4. Brief discussion of the implications of the proposed changes on the likelihood of increased or decreased risks and/or benefits to the study participants.

5. If the consent form(s) will be modified, please attach a copy of the new consent form(s) for IRB approval.

PART D (For CONTINUING REVIEW ONLY)

1. Have the risks and/or benefits to the subjects changed from those originally anticipated? __ Yes __ No

2. Did any adverse events or unanticipated problems involving risks to the subjects or others occur? __ Yes __ No

3. Have any subjects withdrawn or have you excluded anyone from the study? __ Yes __ No

4. Have any subjects expressed discomfort or concerns or complained about the research? __ Yes __ No

5. Since the last IRB review, have there been any findings, publications, or other relevant information that relate to risks associated with the research? __ Yes __ No

6. Are any subjects participating in the study who have not signed a consent (and/or assent) form? __ Yes __ No

If you answered "YES" to any of the above questions, please attach a detailed explanation, including actions taken to reduce the risks or discomforts to subjects and/or to communicate new findings or knowledge to subjects. If you are still enrolling subjects in this study, please attach a copy of the current IRB-approved consent form.

PART E (For FINAL REPORT ONLY)

1. Was there any deviation from the originally anticipated risks and/or benefits of the study? __ Yes __ No

2. Did any adverse events or unanticipated problems involving risks to the subjects or others occur? __ Yes __ No

3. Did any subjects withdraw or did you exclude anyone from the study? __ Yes __ No

4. Did any subjects express discomfort or concerns or complain about the research? __ Yes __ No

5. Did any subjects participate in the study without signing a consent (and/or assent) form? __ Yes __ No

6. To the best of your knowledge, are there any long-term risks to the subjects that were not previously identified or anticipated? __ Yes __ No

If you answered "YES" to any of the above questions, please attach a detailed explanation, including actions taken to reduce the risks or discomforts to subjects and/or to communicate new findings or knowledge to subjects. (NOTE: Per Federal guidelines, future analysis of data from this study to address additional research questions will require a new IRB application.)

PART F (For ALL REPORTS)

CERTIFICATIONS: I certify that the approved protocol and the approved method for obtaining informed consent, if applicable, have been followed during the period covered by this report and/or will continue to be followed throughout the continuation period. If this request is for continuation, I will continue to observe the ethical guidelines and regulations regarding the protection of human subjects from research risks and will continue to adhere to the policies and procedures of the UNC-Asheville Institutional Review Board. I agree to obtain informed consent of subjects who are to participate in this project according to the procedures approved by the IRB; to report to the IRB any unanticipated effects on subjects which become apparent during the course or as a result of experimentation and the actions taken as a result; to cooperate with the IRB in the continuing review of this project; to obtain prior approval from the IRB before amending or altering the scope of the project or implementing changes in the approved consent form; and, for IRB purposes, to maintain documentation of consent forms and other research notes for at least three years after completion of the research.

SIGNATURES:

_____________________________________________ __________________

Responsible Investigator(s) Date

_____________________________________________ __________________

Faculty Advisor (for Student Projects) Date

FOR IRB USE ONLY:     Date Received:     Expedited: __ Yes    __ No

IRB Signature:   Date Approved:     New Expiration Date:

_________________________________________ ____________________ ____________________