Application To The Institutional Review Board For The Protection Of Human Subjects Page 3
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8Human subjects are involved in a project if it utilizes data derived from human
responses, observations of human beings or human materials, whether such
data is obtained directly from the human source or utilizes secondary data.
Are human subjects involved in this project? Yes ________
No ________
If the answer to the above is yes, complete the following:
Section B
An individual is considered to be at risk if he/she may be exposed to the
possibility of harm-physical, psychological, sociological or other—as a
consequence of any activity which goes beyond the application of those
established and accepted methods necessary to meet his/her needs.
The most obvious examples of placing subjects at risk include the experimental
use of medical procedures. There is however a wide range of social and
behavioral projects in which, although there may be no immediate physical risk,
procedures are introduced which involve discomfort, anxiety, harassment,
invasion of privacy, or constitute a threat to the subject’s dignity though the
imposition of demeaning of dehumanizing procedures. Finally, the risk element
will be examined for those studies dependent upon stored data, or information,
which have been obtained for a different purpose.
If an activity will expose an individual to risk, then the committee will wish to
assure itself that
•
the rights and welfare of the individual are adequately protected
•
the methods used to obtain informed consent are adequate and
appropriate, and
•
the risks to the individual are out-weighed by the importance of the
knowledge gained
One
1. With respect to the above criteria the human
Yes
No
subjects are at risk
2. Students will be used as subjects
Yes
No
3. Experimental drugs will be used
Yes
No
4. Experimental devices will be used
Yes
No
5. Non-English speaking subjects will be used
Yes
No
6. Minors will be used (less than 18 years)
Yes
No
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