Loyola University Maryland

Office of Research and Sponsored Programs

Participation of Human Subjects Approval

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1.
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2. If you are a student, provide the following:
3.
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4.

Dates during which research with human participants will take place (including all contact with human participants and until analysis of subject identifiable data and records are complete or access to identifiable data and records is no longer necessary):

5.
Has this project been previously considered by the Loyola Institutional Review Board?

6.
Is a proposal for external support being submitted?

If yes, you must submit one complete copy of that proposal as soon as it becomes available and complete the following:
c) Is notification of human subjects approval required?

7. Description of Human Participants
8a.
In your judgement, does your research fall under one of the six exempt categories?

If you believe it does, indicate the category under which you are claiming exemption. A listing of exempt categories is included in Loyola University Maryland's Policies and Procedures for Research Involving Human Participants, found on the ORSP website.
Category:





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.

9. Student Projects Only
Is this project an independent research project, thesis, or dissertation?

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

10.
11a.
Is any of the information being gathered Protected Health Information covered by the Health Insurance Portability and Accountability Act (HIPAA)?

11b.
If yes, are you using an informed consent document that is consistent with HIPAA regulations?

12. Procedures
13. Description
14. Consent
15. Benefits
16. Risks
17.

Starting June 1, 2009, any faculty member or other Loyola employee conducting independent research or overseeing student-conducted research and any student working on independent research, a dissertation, or thesis that involves research with human subjects,is required to complete a free online education program prior to the review of his or her Application for Approval of Investigation Involving Human Participants. If the application is for a classroom project, the faculty member who assigned the project is responsible for completing the online program, acquainting students with the human subjects education, and ensuring that classroom-based projects are conducted in accordance with Loyola University Maryland's Policies and Procedures for Research Involving Human Participants. The online education course can be accessed at http://phrp.nihtraining.com/users/login.php. An initial copy of the program certificate of completion must be submitted to the office of research and sponsored programs, either directly or with an application. Further submission of the certificate is not required unless updated information is released through the online program.

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.
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20. Upload any other supporting documents