Institutional Review Board Minutes
May 10, 2001
Members Present: Allen, Coogan, Ferrari-Comeau, Kay, Lamb, Preiss, Stewart, Wadsworth, &
Woodward.
This IRB meeting was opened at 2:06 PM in room 326 of Wyatt Hall.
1) Approval of the minutes from the April 25 meeting will be deferred until the next Board
meeting. Board members are encouraged to access the April 25 minutes, via the University
website, and review them for accuracy.
2) Ray Preiss reports that he will present the annual IRB report to the Faculty Senate on May 14,
2001.
New Business:
3) Review of Protocol #0001-016.
The following issues were raised:
• Board members voiced considerable confusion as to the number and composition of
experimental groups. For example, pertaining to the "activity questions" of Appendix
B, is there a distinction to be made between a "swimmer" and a physically "active"
individual? Are not swimmers active? The Board wishes to alert the investigator to
the possibility of confusion on the part of potential subjects as they attempt to
complete this form.
• Concern was expressed regarding the level of risk inherent to the VO2 max test when
assessing physically inactive subjects. Is there information in the literature which
assesses the safety and specific risks of the particular V02 max protocol proposed
here, when applied to sedentary individuals? The protocol is somewhat inconsistent
in specifying the level of risk associated with this test.
• Should subjects be exposed to the V02 max test and LBNP protocol on separate days
to avoid confounding the results of one assessment due to the physiological
demands of the other?
• If a subject responds to item 5 or 8 of the Physical Testing Readiness Questionnaire in
a manner requiring follow-up inquiry by the investigator, what specific criteria will be
applied at that time to determine subject suitability and safety?
• More specificity regarding contraindicated medications is warranted on the Physical
Testing Readiness Questionnaire.
• The is not the first time the Board has reviewed a protocol employing the use of the
Physical Testing Readiness Questionnaire as a medical screening tool to determine if
subjects are medically safe to participate in a research study. Questions arose
regarding whether or not this is a standard instrument and what literature exists
which speaks to its validity as a medical screen for safe subject participation in the
type of research proposed. The Board requests that the investigator provide
information regarding the origin of this scale and cite relevant literature addressing its
validity for use in this context.
• What are the qualifications and training of research personnel for handling potential
medical emergencies and operating the on-site defibrillator?
• The purpose statement, as worded on the consent form, requires clarification.
Action on this protocol is deferred until the above issues are addressed. These concerns
will be communicated to the investigator, who will be asked to submit a revised
protocol for reconsideration.
4) Review of Protocol #0001-017.
The following issues were raised:
• Why are subjects being asked to stand on a 4" platform? Might some subjects have
difficulty with this? Is the platform necessary?
• The protocol contained no discussion of the home testing set-up. Is it identical to the
clinic set-up?
• What is the upper age limit for potential subjects?
• The protocol lacks sufficient specificity in describing details of the kicking task.
• There appear to be feasibility issues regarding set-up of the assessment tasks in a
home setting. The Board recommends piloting the procedure to determine if the
assessment tasks can actually be set-up in the home in a manner consistent with the
clinic set-up.
• Regarding the consent form, please clarify as to whether home/clinic sessions will be
held on the same day(s) and indicate what will be the extent of time commitment and
transportation requirements of full participation. The consent form must also include
a sentence stating that refusal to participate, or discontinuation of participation, will
not impact the therapy provided to the child.
This protocol was approved, pending revisions addressing the above issues, by a vote of
9-0-0.
5) The meeting was adjourned at 2:50 PM.
Respectfully submitted,
Roger Allen, IRB secretary