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About ETBU

IRB Application

Directions for Online Submission

Documents to include:

  1. Detailed literature review
  2. Research instrument, such as surveys/questionnaires or interview schedules
  3. Sample Informed Consent form
  4. Any other relevant documents
  5. PHRP Office of Extramural Research Certificate

Assurances

Read the assurances carefully before filling out the Online Application for Review of Human Subjects Research form.

1. I certify that all information provided in this application is complete and correct.

2. I understand that, as Principal Investigator, I have the ultimate responsibility for the conduct of this study, the ethical performance of this project, the protection of the rights and welfare of human subjects, and strict adherence to any l performance of this project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the ETBU IRB.

3. I agree to comply with all ETBU policies and procedures, as well as with all applicable federal, state, and local laws regarding the protection of human subjects, including, but not limited to the following:

     a. Conducting the project by qualified personnel according to the approved protocol.

     b. Implementing no changes in the approved protocol without prior modification approval from the IRB.

     c. Obtaining informed consent from each participant or their legally responsible representative prior to their participation in this project employing only the currently approved means of consent (e.g., form).

     d. Promptly reporting unanticipated problems and/or adverse events to the IRB in writing within 5 working days after learning of the occurrence.

     e. Conduct this study only during the time period approved by the ETBU IRB.

4. I will prepare and submit a continuation request and supply all supporting documents to the IRB office at least two weeks before the approval period has expired if it is necessary for me to continue the research project beyond the time period approved by the ETBU IRB. 

Address
One file only.
75 MB limit.
Allowed types: txt rtf pdf doc docx odt ppt pptx odp xls xlsx ods.
 How many subjects will be used and how will they be selected? (If consent will have to be given by proxy, be sure to include a statement of why this particular object merited with this population.)
Include sufficient detail so that the committee can independently evaluate risks to subjects. 
Describe explicitly the risks to research participants. If the project involves more than minimal risk to subjects (see definitions in the IRB Policies and Procedures document), include a statement of why the supposed benefits of the research outweigh the risks to the subjects.
Describe the procedures you will use to insure that information gathered from participants will remain confidential, or give reasons why confidentiality can not be maintained. In cases involving sensitive or potentially embarrassing information, where subject identities are to be retained, please include your security procedures.
Document how informed consent will be obtained (see IRB Policies and Procedures). Include the exact words you will use to fully inform participants of the nature of the study and the extent of their involvement before they agree to participate.
If you plan to use deception or to withhold information from participants, explain how you plan to do this and state your reasons for doing this.

File Uploads

Maximum 5 files.
75 MB limit.
Allowed types: gif jpg png bmp eps tif pict psd txt rtf html odf pdf doc docx ppt pptx xls xlsx xml avi mov mp3 ogg wav bz2 dmg gz jar rar sit svg tar zip.
Research instrument, such as surveys/questionnaires or interview schedules
One file only.
75 MB limit.
Allowed types: gif jpg png bmp eps tif pict psd txt rtf html odf pdf doc docx ppt pptx xls xlsx xml avi mov mp3 ogg wav bz2 dmg gz jar rar sit svg tar zip.
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