Fillable Research Review And Approval Form printable pdf download

Research Review and

Approval Form: Parts A and B

This form serves as both a decision making tool and application for IRB approval of

research projects involving human subjects.

PROJECT INFORMATION

Principal Investigator Name: ___________________________________________________________________________________

Street: ____________________________________________________________________________________________________

City: _______________________________________________________________ State: ______ Zip/Postal Code: ___________

Phone Number: ___________________________

Email Address: ____________________________________________________

Project Title: ______________________________________________________________________________________________

Project Duration: from ______________________________________ to __________________________________________

Research is a systematic investigation designed to develop or contribute to generalizable knowledge, through dissemination by publication or

presentation. Human subjects are living people about or from whom an investigator conducting research obtains data through interaction or

identifiable private information. The Principal Investigator is the person conducting the research who is responsible for assuring that all research

procedures are followed correctly. The Principal investigator is under the auspices of the University, such as a staff member at the University or

State Library. When systematic data about human subjects are collected, especially for the purpose of dissemination, an IRB review and approval

process must be followed according to federal regulation 45 CFR ( ).

TYPES OF IRB REVIEW

1) Types of IRB Review: Depending on the level of risk of the research protocol and the participant population, IRBs may conduct either full board

review or expedited review.

a) Expedited Review

i) For certain kinds of research involving no more than minimal risk and for minor changes in previously approved research,

the IRB Chair and a designated voting member or group of voting members review the proposed research rather than the

entire IRB.

ii) It cannot be assumed that research poses minimal risk because it involves only interview or survey data collection. Sensitive

questions may lead to distress that exposes participants to greater than minimal risk. Loss of confidentiality can cause

harm to participants, their relatives, and others. The IRB determines the designation of Expedited Review.

iii) See the following web site for a list of procedures which may be approved through expedited review:

b) Full Board Review

i) When full board review is necessary, the research proposal is presented and discussed at a meeting at which a quorum of

IRB members is present.

ii) For the research to be approved, it must receive the approval of a majority of those voting members present.

iii) IRB members may participate by means of electronic and/or telephonic communication and need not be present physically.

c) Research Exemptions from IRB Review

i) Under Federal regulations [45 CFR 46.101 (b)], certain categories of activity are considered research but may be declared

exempt from review by the IRB. This determination must be made by the IRB prior to the research being conducted.

ii) Certain low-risk research is exempt from the requirements in the Federal regulations concerning IRB review and approval.

If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants' rights.

The researcher should not make the final determination of exemption from the applicable Federal regulations or the provisions of the institution.

Research Review And Approval Form