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Irene Mcclay
02-26-1993, 02:15 AM
Dear Networkers,
I am currently engaged in research which focuses on lower extremity mechanics
and injury. In searching for subjects with particular running mechanics, I
often have subjects who fit the criteria but are over age 40. Historically,
our human subjects review board requires a physician present for these
subjects. In checking with the ACSM recommended quidelines, they note that
if the exercise is considered moderate and subjects are apparently healthy,
no age restrictions nor physician superivision is necessary. I am having
subjects fill out a health history questionnaire (the PARQ - recommended by
ACSM). In addition, for inclusion, subjects must be engaged in a running
program for a period of 6 months and be running a minimum of 2-3 miles, 3 dpw.
The protocol requires them to run on a treadmill at their typical running
pace (8 min/mile) and to make a number of passes over a force plate along
a 75 ft runway. This level of exercise is below that which the subject
is currently engaged. The difficulty in having a physician present relates
both to cost and scheduling. The majority of these subjects must be tested
during evenings and weekends. Based upon the ACSM guidelines, these subjects
are not in a high risk group. Additionally, the Office of Protection from
Research Risks (OPRR - Health and Human Services) state clearly in their
guidelines that they allow expedited review for reseach involving minimal
risks to subjects and go on to list "moderate exercise by healthy volun-
teers. I have provided our review board this information and will be
meeting with them soon. I would like to know if there are other university-
based research programs in the US which have similar protocols in place
and are testing subjects over 40 without the presence of a physician. I
thank you in advance for your assistance.
Sincerely,

Irene McClay, PhD, PT
Motion Analysis Laboratory
Univerisity of Delaware
cwv03814@udelvm
(302)831-4263