INSTRUCTIONS FOR USE OF HUMAN PARTICIPANTS RESEARCH REVIEW

Introduction

Investigators and others will recognize that conducting research with human participants is not a right but a privilege. This privilege is granted to investigators who after thorough scrutiny by the IRB can demonstrate that they intend to conduct important high quality research that provides appropriate protection to human participants (National Institute of Health, 2002).

In filling out the attached forms, please keep in mind that participants must be treated with respect for their right to be well-informed prior to the study about what will happen to them and what behaviors are requested of them. They should be aware of any risks involved in the study and must then freely give their consent to participate. The option not to participate or to terminate participation at any time must be explained clearly. Participants must also be guaranteed confidentiality for any information they provide and for any information about themselves. It is also important, in terms of maintaining the good will of our participant population, to make provisions to inform participants of the purpose of the study and the importance of their role in it.

Please use the following forms to complete your application for research:

Checklist for Initial Review (Word Format)

IRB Application Form (PDF)

IRB Application Form (Word Format)

Completed applications should be sent to Dr. Bowen in Francis Hall 136.

The Review Procedure

Complete and securely attach the following:

*Please note that it is the responsibility of the researcher to submit the application and supporting documentation in its entirety to the IRB. Submissions will only be accepted in hard copy with an original signature indicating the advisor's approval.

1. Submit your completed proposal with all attachments to the IRB by the appropriate date (see IRB meeting and deadline schedule). Failure to submit proposals in a timely manner may delay academic progress.

2. Upon determination that proposal is complete, the research assistant for the IRB will inform the researcher and advisor of the proposal’s anticipated review path: either expedited or full review. Incomplete proposals will be returned to the researcher.

3. IRB committee will review all full review proposals and will make one of three decisions regarding the project: Fully Approved, Conditionally Approved, Disapproved, or Incomplete. Expedited proposals will be reviewed by the research assistant for the IRB.

4. After the IRB has made a project decision, the researcher and advisor will receive notification via email or mail-within three working days concerning the status of the proposal. (Please consult with your advisor.)

5. Those individuals with approved proposals may begin research upon receipt of approval.

6. Those individuals granted conditional approval MUST meet the terms of conditions as denoted in the written notification and receive notification of full approval by the IRB PRIOR to beginning research.

7. Proposals that are not approved may NOT be initiated.

8. If your proposal is approved, you will be required to submit a Progress Report to the IRB on your activity at the conclusion of your study, or at the 1 year anniversary of the granting of approved by the IRB Committee. Failure to complete the Progress Report may result in sanctions (for example, an incomplete for the course or inability to obtain an academic transcript).

9. The IRB will conduct audits of randomly selected research projects.

Researchers may wish to consult the following websites for information about national guidelines on human participant research.

National Institute of Health, Office of Human Participant Research
Office of Human Research Protection

Members of Alvernia University’s IRB Committee are available for consultation.

 

Updated: November 25, 2008
Your comments are welcome.