|
> Research > Human Subjects Research > NYUCD Human Subjects Protocol >
III. Protocol Design
III. Protocol Design
Purpose
Any prospective or retrospective investigation requires a comprehensive
description of the protocol (see below). A scientific/biological
rationale for the study is indispensable and required by the
IRB. A comprehensive protocol will ultimately guide the investigators
in conducting a study that will yield potentially useful information
that can be published and that will impact scientific knowledge.
After approval from the NYUCD IRB and Research Proposal Oversight
Committee, the research protocol will be submitted to the appropriate
IRB. No study can be initiated at NYUCD before written approval
of the protocol from the NYUSM IRB or the OSP IRB.
Process
All consent forms must contain, at a minimum, the following:
- Introduction/Abstract
- Objectives/Rationale
- Methods and Procedures
- Inclusion and Exclusion Criteria
- Potential Benefits to Subjects
- Potential Risks to Subjects
- Subject Recruitment Strategies and Compensation
- Study Management and Personnel
- Confidentiality Statement
- Data Analysis Strategy
- Bibliography
- Appendices
OSP IRB Applications
Application for Review by the University Committee on Activities
Involving Human Subjects (Appendix 3). Retrieve form: www.nyu.edu/ucaihs/
NYUSM IRB Applications
NYU Langone IRB Forms & Templates Library: http://irb.med.nyu.edu/researchers/library/guidance
Application for New Protocol (Appendix 5). Retrieve from:
http://irb.med.nyu.edu/sites/default/files/irb2/app.new_.full_.or_.expedited.2012.03.07.docx
|
