UCRIHS Form

INSTRUCTIONS FOR UCRIHS APPLICATION SOFTWARE

1. AS YOU COMPLETE THE FIRST PAGE OF THE APPLICATION, please USE the TYPEOVER mode (hit the Insert key--Typeover should appear in the lower left corner). This will preserve the format of the application.
2. Refer to the lavender instruction sheets to fill out this application. If you do not have a copy of the lavender instructions, please call the UCRIHS office (355-2180).
3. Remember to submit the correct number of complete, collated copies of your application.

4. If possible, please print one copy of the application on yellow paper.

5. When you are ready, press Page Down, to continue.

DO NOT TURN IN THIS PAGE TO THE UCRIHS OFFICE.

APPLICATION FOR APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS - INITIAL REVIEW

UCRIHS - Michigan State University

David E. Wright, Ph.D., Chair

225 Administration Building

East Lansing, MI 48824-1046

(517) 355-2180 - Telephone . . . (517) 432-1171 - FAX

Office Hours: M-F (8:00 A.M.-Noon & 1:00-5:00 P.M.)

DIRECTIONS: Please complete questions on this application using the instructions and definitions found on the lavender sheets (revised July 1994).

1. RESPONSIBLE PROJECT INVESTIGATOR(S) ADDITIONAL INVESTIGATOR(S)

(Faculty or staff supervisor)

Faculty ID#: Fac./Stu. ID#:

(Social Security #)

I believe the research can be safely completed Fac./Stu. ID#:

without endangering human subjects. Further,

I have read the enclosed proposal and I am Fac./Stu. ID#:

willing to supervise any student investigators.

Fac./Stu. ID#:

(Signature)

2. ADDRESS ADDRESS

(for comments/approval letter) (for comments/approval letter)

Phone #: Phone #:

FAX #: FAX #:

3. TITLE OF PROPOSAL

4. PROPOSED FUNDING AGENCY (if any)

5. DOES THIS PROJECT UTILIZE AN INVESTIGATIONAL DRUG, DEVICE OR PROCEDURE?

Yes [ ] No [ ] If yes, is there an IND #? Yes [ ] No [ ]

6. DOES THIS PROJECT INVOLVE THE USE OF MATERIALS OF HUMAN ORIGIN (e.g., human BLOOD OR TISSUE)? Yes [ ] No [ ]

7. DOES THIS PROPOSAL HAVE AN MSU ORD NUMBER? Yes [ ] # No [ ]

8. WHEN WOULD YOU PREFER TO BEGIN DATA COLLECTION?

Please remember you may not begin data collection without prior UCRIHS approval.

9. CATEGORY (Circle A, B or C below. See instructions.)

a. This proposal requires review by a full sub-committee.

b. This proposal is eligible for expedited review. Specify category or categories

.

c. This proposal is exempted from full sub-committee review. Specify category or categories .

FOR OFFICE USE ONLY

Subcommittee Agenda

10. PROJECT DESCRIPTION (ABSTRACT)













11. PROCEDURES










12. SUBJECT POPULATION

a. The study population may include (check each category where subjects may be included by design or incidentally):

Minors [ ]

Pregnant Women [ ]

Women of Childbearing Age [ ]

Institutionalized Persons [ ]

Students [ ]

Low Income Persons [ ]

Minorities [ ]

Incompetent Persons (or those

with diminished capacity) [ ]

b. Number of subjects (including controls)

c. If you are associated with the subjects (e.g., they are your students, employees, patients), please explain the nature of the association.





d. How will the subjects be recruited?



e. If someone will receive payment for recruiting the subjects, please explain the amount of payment, who pays it and who receives it.



f. Will the research subjects be compensated? [ ] No [ ] Yes. If yes, details concerning payment, including the amount and schedule of payments, must be set forth in the informed consent.

g. Will the subjects incur additional financial costs, as a result of their participation in this study? [ ] No [ ] Yes. If yes, please include an explanation in the informed consent.




h. Will you be advertising for research participants? [ ] No [ ] Yes. If yes, attach a copy of the advertisement you will use.

i. Will this research be conducted with subjects who reside in another country or live in a cultural context different from mainstream US society? [ ] No [ ] Yes.

(1) If your answer is yes, will there be any corresponding complications in your ability to minimize risks to subjects, maintain their confidentiality and/or assure their right to voluntary informed consent as individuals? [ ] No [ ] Yes.

(2) If your answer to i-1 is yes, what are these complications and how will you resolve them?








13. ANONYMITY/CONFIDENTIALITY









14. RISK/BENEFIT RATIO









15. CONSENT PROCEDURES








Is your application COMPLETE? Please SEE the CHECKLIST on page four of the UCRIHS Instructions.