Protocol for Human Subjects Research

AN-NAJAH UNIVERSITY

PROTOCOL FOR HUMAN SUBJECTS RESEARCH

CONTINUING PROJECTS ONLY

Investigator’s Assurance

By submitting this protocol, I attest that I am aware of the applicable principles, policies, regulations, and laws governing the protection of human subjects in research and that I will be guided by them in the conduct of this research.

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To apply for human subjects continuing review:

1.Download the continuing projects protocol and save it on a floppy disk or on your hard drive. You may then open it, type in all requested information, save the file (Please use your last name and Continuing Protocol as the title: e.g., Musmar Continuing Protocol), and send the file as an e-mail attachment, along with your informed consent letter(s), to the Institutional Review Board at “”.

It is essential that you answer all questions on this form since this is the primary source of information used by Board members to make their decisions. Also, only include information necessary to answer the questions. Please keep your responses as free of jargon as possible.

Please send, by campus mail or regular mail, all supportingthat cannot be e-mailed (e.g., measures, permission letters from off-campus sites) to the IRB Office, An-Najah University, Nablus, Palestine . If you are proposing changes to your approved project, please send any necessary supporting materials. If you are continuing to enroll human subjects, be sure to send your Informed Consent, printed on An-Najah letterhead, for stamping with the new IRB approval inclusion dates.

PLEASE DO NOT INCLUDE THIS PAGE IN YOUR SUBMISSION

PLEASE BE SURE TO COMPLETE ALL SECTIONS:

Principal Investigator: ______

Department/School______

Room # where mail can be sent ______

Phone ______E-mail ______

Date of Current Submission: ______

Issue date of most recent Report of Action (ROA): ______

Expiration date of most recent ROA: ______

Title of Research: ______

PURPOSE OF RESEARCH

Briefly describe the objective(s) of the research (please keep description jargon free and use 100 words or less). You may paste the paragraph from your original IRB New Project Protocol.

Dates Human Subjects Portion of Research Scheduled: from: ______to ______.

STATUS OF RESEARCH

Number of subjects anticipated for the entire project: ______
Number of subjects from or about whom data has been gathered to date: ______
Number of subjects for whom you have signed consent forms: ______
Number of subjects who refused to participate: ______
Please describe reasons, if known:
Number of subjects who withdrew from participation: ______
Please describe reasons, if known:
Please describe any complications or deviations from the approved research:
Please describe any adverse events or unanticipated problems involving risks to subjects or others: