*Forms are subject to change. Check for the latest forms on IRBNet.Reporting Form for Research Concerns/Complaints

Tulane University Human Research Protection Program
Reporting Form for Research Concerns/Complaints

Date:

Instructions for Submitting this Form:

You may choose to use this form to report a concern or complaint. You may send us this form in one of three ways:

By email:

By fax: (504) 988-4766

By mail:TulaneUniversity HRPO
1440 Canal St., Suite 1705, TW-36
New Orleans, LA70122

There are two additional ways you can choose to report a concern or complaint:

  • You may choose to report your concern or complaint by phone by calling (504) 988-2665. If you wish to make a report by phone, please ask for the person who handles concerns or complaints.
  • You can also send a letter to the address above to report your concern or complaint. If you send us a letter, you may find it helpful to use the questions in this form as a guide for the content of your letter.

Note: All research concerns and complaints are taken very seriously. The information you provide on this form will be kept as confidential as possible. However, we may need to share this information with others in order to follow-up with your concern or complaint.

  1. Your Name (Optional or Initials Only):
  2. May we reveal that you are the source of this concern or complaint to the study’s Principal Investigator and other study staff? Yes No
  3. Personal Contact Information (REQUIRED if you wish to hear back from us regarding this complaint):
  4. Phone:
  5. Email Address:
  6. Other Contact Info:

Note: Unless you authorize us to do so, your personal contact information will not be released to anyone outside the Tulane HRPO.

  1. Are you making this report for someone else: Yes No

If yes, please explain:

Study Information – Please tell us about the study for which you have a concern or complaint:

  1. Study Name or Description:
  2. Name of Study Investigator:
  3. Study Phone Number:
  4. Please tell us about the research concern or complaint you are reporting:
  5. Please tell us how you would like to see your concern or complaint resolved:
  6. Have you discussed this concern or complaint with the Principal Investigator or other study staff?
    Yes No
  1. If yes, please let us know who you contacted:
  1. Are you or were you a participant in this study? Yes No
  1. If yes, please answer the following 4 questions:
  1. When did you start participating in the study? (Estimate if you cannot remember exactly)

Date:

  1. Are you still participating in this study? Yes No
  1. Do you have a Consent Form for this study? Yes No
  1. Do you have any other written information about this study? Yes No

Note: If yes, please attach a copy of the Consent Form or other written information that you have.

If you have additional comments or need additional space, please attach additional sheets.

FOR HRPO USE ONLY / Date Received:
Received By:
Referred To:
Study Information:
Study Title:
IRB #:
PI:
PI Contact Info:
HRPO Action Taken:

1

Issued: 9/24/09 Last Reviewed: 11/1/12
Effective: 9/24/09 Last Revised: 9/24/09
Form #: 604