CARNEGIE MELLON UNIVERSITY
HUMAN SUBJECTS CLEARANCE REQUEST
DATE:
CMU Protocol No.
(for office use only)
New Request
Renewal
Principal Investigator(s):
P.I. Title/Degree:
Department
Phone:
E-mail:
Project Dates:
From
To
Project Title:
Name of Experimenter(s):
Source of Funding (Sponsor): Internal:
External:
Brief Description of Research:
1.
How many subjects will be used in this experiment?
2.
From what source do you plan to obtain subjects?
3.
Is there any benefit gained by the subject for participating?
4.
Will the subjects include any of the following:
NO
YES (please check below)
Fetuses
Hospitalized Patients
Institutionalized Patients
Mentally Disabled
Mentally Retarded
Minors
Pregnant Women
Prisoners
5.
Degree of Physical Risk:
____Negligible
____Mild
____Moderate
____High
6.
Degree of Psychological Risk:
____Negligible
____Mild
____Moderate
____High
7.
Do you or any individual who is associated with/responsible for the design, the conduct, or the reporting of
this research have an economic interest in or act as an officer or a director for any outside entity whose financial
interests would reasonably appear to be affected by this research project?
__________Yes*
__________No
(*if yes, please provide detailed information to permit the IRB to determine if such involvement should be disclosed
to potential research subjects.)
Please submit each of the following with this Clearance Request form:
1.
A draft of the proposal or abstract
2.
A clear definition of how the subjects will be utilized or how the experimental treatment will be administered
3.
A copy of the "informed" consent form(s) that the subjects will be required to sign
4.
An indication of how confidentiality/anonymity will be protected
5.
The name(s) and address(es) of official(s) authorizing access to any subjects in cooperating institutions not under the
direct control of Carnegie Mellon
6.
Risk/Benefit analysis
7.
A statement describing how participants will be recruited (include advertisement flyers/invitation letters/invitation emails)
8.
A copy of your on-line training certificate (http://cme.nci.nih.gov/)
10/02sms