Research Review And Approval Form Page 3
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4Research Review and
Approval Form: Part B
Application for IRB Approval
DIRECTIONS
The following items must be supplied and submitted to the IRB member identified on the University web site. All information is to be included.
Questions can be directed to the IRB member or IRB Chair, contact information is identified on the web site.
1. Project title
2. Contact Information for Principal Investigator
a. Contact information for Additional Investigators/team members
b. Report of Human Participant Protection Education for PI and Research Team members
3. Funding Status
4. Project Time Line (Estimates are acceptable)
a. Start of data collection
b. End of data collection
c. Period of data analysis
d. End of study
5. Participants in the study: Provide a description of the participants in the study; include age, sex, ethnicity, race, and other identifying
characteristics. Provide rationale for the use of vulnerable populations. Describe any precautions that would be taken to minimize risk
to participants. Describe procedures for obtaining consent/assent. If consent is not to be obtained, provide a rationale.
a. Attach consent form if applicable
6. Location of the study:
a. Name, address, description
b. Attach letter of agreement from appropriate facility personnel
7. Research Proposal (attach): The proposal should include the following information, in the order indicated, from your research project.
a. Specific Aims of the Study
b. Sample characteristics:
i. Statement regarding the processes that you will use to recruit participants
ii. Describe sample demographics and sampling plan
c. Methods of Data Collection and Analysis
i. Be sure to include a description of any quantitative and/or qualitative techniques.
ii. Attach any questionnaires, surveys, tests, tools or research instruments
d. Statement of potential risks to participants that are inherent in this research protocol.
i. For example, identify possible sources of: breaches of confidentiality, treatment complications, psychological distress
e. Statement regarding precautions and safeguards that are incorporated into the design to minimize potential risks.
f. Statement of potential benefits to the participants.
g. Statement regarding precautions and safeguards that are incorporated into the design to maximize potential benefits.
h. A step-by-step description of the procedures that will be used in this project.
Signature of the Principal Investigator:
The
undersigned
accepts
responsibility
for
this
study,
including
adherence
to
DHHS,
FDA
( ) and Thomas Edison State University policies regarding the rights and welfare of
individuals who serve as participants in this study.
____________________________________________________ Date___________________________
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