Participation of Human Subjects Approval

1.

Principal Investigator:*

Phone:*

Email:*

Mailing Address:*

Co-Investigators:

2. If you are a student, provide the following:

Faculty Sponsor:

Campus Phone:

Department:

3.

Project Title:*

4.

Date research with human participants will begin:

Date research with human participants will end:

5.

Has this project been previously considered by the Loyola Institutional Review Board?

Yes

No

Log number (if yes):

Approval date (if yes):

6.

a) Name of grant program:

Is a proposal for external support being submitted?

Yes

No

b) Name of grant agency:

c) Is notification of human subjects approval required?

Yes

No

7. Description of Human Participants

Quantity:

Age:

Male:

Female:

8a.

In your judgement, does your research fall under one of the six exempt categories?

Yes

No

Category:

A

B

C

D

E

F

8b. If you are claiming exemption, skips questions 8b and 15-16

Does your project fall under one of the categories eligible for expedited review? A listing of expedited categories is included as an attachment to Loyola's Policies and Procedures for Research Human Participants, found on ORSP's website.

Yes

No

9. Student Projects Only

Is this project an independent research project, thesis, or dissertation?

Yes

No

If no, is your project a supervised student project that was assigned as a part of the requirements for a course?

Yes

No

Course name and number:

10.

Describe the source(s) of participants and the selection criteria. Specifically, where did you obtain the names of potential participants (i.e. agency files, hospital records, local organizations, etc.)? Where and how will you contact them?

11a.

Is any of the information being gathered Protected Health Information covered by the Health Insurance Portability and Accountability Act (HIPAA)?

Yes

No

11b.

If yes, are you using an informed consent document that is consistent with HIPAA regulations?

Yes

No

If the response is no, you must attach an Addendum to Application for Approval of Investigation Involving Human Participants, Request for Waiver or Alteration of Patient Authorization Requirements to this application.

12. Procedures

Provide a step-by-step description of each procedures

13. Description

Briefly describe the proposed research: Include major hypothesis and research design.

14. Consent

Describe the informed consent process and attach all consent documents. For projects involving minors: describe the process through which assent will be obtained and attach copies of assent forms. If you have not indicated that the project is exempt and consent and/or assent will not be obtained, explain why a waiver is requested.

Consent document:

Assent document:

15. Benefits

Describe the anticipated benefits to participants and the importance of the knowledge that may reasonably be expected to result.

16. Risks

Describe the risk involved with these procedures (physical, psychological, and/or social) and the precautions you have taken to minimize these risks.

17.

Certificate number:

Certificate date:

Upload a copy of your certificate:

Or, provide a link to the web page where your certificate can be viewed:

18.

Principal Investigators must submit a Request for Amendment form when seeking to make a change to a study that has already been approved. Committee approvals for expedited and full review applications are for one-year periods. If the research activity extends past one year, applicants must submit a Request for Renewal form at least three weeks prior to the expiration of the initial approval period. Any problems connected with the use of human participants once the project has begun must be reported to the office of research and sponsored programs and/or the Institutional Review Board immediately.*

I agree to provide whatever surveillance is necessary to ensure that the rights and welfare of the human participants are properly protected. I understand that I cannot initiate any contact with human participants before I have received approval and/or complied with all contingencies made in connection with that approval

19. Upload any other supporting documents

Document 1:

Document 2:

Document 3:

Document 4:

Explore Greyhound Nation

Participation of Human Subjects Approval

Announcements