Date: __________________

To: IRB

From: ____________________________________________________________

Office Location _______ Tel. No. _______ FAX No. ________ E-mail:_________

Title of Research Activity: _________________________________________

Nature of Research Activity:_________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Associate or Collaborating Investigator(s):

Name:  ______________________________________________________

Institution: ____________________________________________________

Address:  ____________________________________________________

Tel. #_____________________   E-mail: __________________________

FAX #_______________________________________________________

Proposed Starting Date of Research Activity: ________________________

Expected Duration of Research Activity: _____________________________

Please Answer All the Following Questions Regarding this Research Activity:

1. Please describe your role in this research activity: ____________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

2. Where are the participants of this research activity located?

_________________________________________________________________

_________________________________________________________________

        a.    If the research activity is taking place elsewhere will you have direct contact or intervention with the human participants? (Examples: in obtaining samples directly from the participant, by interviewing the participant?).

        b.    Has the activity been reviewed and approved by an Institutional Review Board (IRB) elsewhere? Yes ____ No ____

            If "Yes", specify which IRB and when reviewed ___________________

3.    What kind of human samples (e.g., tissue, saliva, blood) or data (e.g., private information, responses to questionnaires) will be involved?
______________________________________________________

_________________________________________________________________

_________________________________________________________________

Will you be:

collecting Yes___ No___

receiving Yes___ No___

sending Yes___ No___

these samples or data?

4.    Do the samples or data:

(a) Already exist? Yes___ No___

(b) Are they being collected for the purpose of this study? Yes___ No___

(c) Or a combination of (a) and (b)? Yes___ No___

If "Yes" to (c), please describe: ______________________________________

_________________________________________________________________

5.    Do the samples or data come from individuals who may need special safeguards (e.g., children, pregnant women, or prisoners)? Yes___ No___

        If "Yes", please specify ________________________________________

6.    An IRB must review and approve the use of existing samples or data that are coded and may be linked in any way to an individual, or that contain personal identifiers. The use of samples or data that are anonymous (i.e., are not coded or linked in any way to an individual) may be considered for exemption from IRB review and approval. Are the samples or data you expect to collect, receive or send anonymous? Yes___ No___
 

Please attach separate sheet if there is anything else you wish to add or any answer you wish to amplify.