Institutional Review Board Minutes
April 25, 2001
Members Present: Allen, Coogan, Ferrari-Comeau, Kay, Lamb, Preiss, Stewart, Wadsworth, &
Woodward
This IRB meeting was opened at 3:02 PM in room 326 of Wyatt Hall.
1) Minutes from the 3/29/01 meeting were approved by a voice vote of 8-0-0 (8 in favor, 0
opposed, 0 abstained), with one modification.
New Business:
2) Review of Protocol #0001-013.
The following issues were raised:
• The cover page of the protocol must include the title of the investigation.
• What are the potential risks associated with subjects breathing sea-level pressure air
with increased nitrogen content? Is this a standard protocol for altitude simulation
appearing in the literature, whose risks have been established?
• The investigators must clarify how nitrogen introduction is to be administered and
nitrogen content monitored.
• The consent form must inform subjects that "simulated altitude air" is accomplished via
nitrogen introduction to replace a percentage of the oxygen content.
• Given that the rationale for the investigation is to investigate factors associated with
sudden cardiac death at high altitudes, the consent form must clearly articulate that
"death risk" may be specifically associated with the altitude simulation via nitrogen
introduction condition.
• Related to the health history form, there is a question as to whether subjects in the
specified age range will actually have had an examination by a physician to establish
whether or not they have a "heart condition."
• Has the health history form been used previously and what validity evidence exists to
support that the sum of its questions adequately screen for potential medical
contraindications to participation in an altitude simulation protocol of this type?
• If a subject does not currently have a local physician will they still be allowed to
participate in the study?
• The investigators must provide a protocol for handling a medical emergency should
one arise during the procedure. What medical emergencies is the testing facility
equipped and staffed to handle? Is immediate physician access necessary?
• The investigator must establish, via the literature, that the warning signs used in the
protocol to stop the procedure fully include the specific early warning signs of sudden
cardiac death.
• If altitude simulation clouds consciousness and judgement, how are subjects expected
to accurately self-report the early warning signs which would warrant termination of
the procedure? What level of reliance do the investigators place on self-reported
symptoms, versus objective signs?
• The protocol must specify the lower range of VO2 max used to categorize "moderately
trained" subjects.
Action on this protocol is deferred until the above issues are addressed. These concerns
will be communicated to the investigators. They will be asked to submit a revised
protocol for reconsideration.
3) Review of Protocol #0001-014.
The following issues were raised:
• The consent form must be presented on University letterhead paper.
• Confusion exists as to the nature and purpose of the last signature line of the consent
form, "Permission to contact corroborator." Is its inclusion an error? Should it simply
be deleted? Investigators "Certifiction" should be corrected to Certification.
• Although a screening tool is provided, the protocol does not clearly specify subject
exclusion criteria.
• During each epoch of pressure reduction, how frequently will arterial blood pressure be
taken? Who will be assessing blood pressure? What objective assurances can the
investigator provide that the individual taking blood pressure has sufficient training,
skill, and competence to perform this task?
• What is meant by "personal solicitation" of subjects? Significant concern arises that by
recruiting personal acquaintances as subjects (e.g. friends, family, etc.) there exists a
possibility of coercion, or it may be implied to the subject that the study presents less
risk than actually exists. Subjects should not be participating out of a sense of
obligation or loyalty to the experimenter which would in any way override his or her
otherwise strictly voluntary disinclination to participate. It is recommended that
"personal solicitation" not be used to recruit subjects. It is also recommended that
the experimenter emphasize to each subject (both verbally and written on the
Physical Activity Readiness Questionnaire) the importance to safety of thoughtful and
honest responses on health history questions.
• For subjects not associated with the University of Puget Sound, will the "free training"
take place at the UPS fitness center? If so, how will they gain access to the center?
Does this raise any special liability issues for the facility or staff of the fitness center?
• The inclusion of a VO2 max test raises the level of risk for this study above "minimal".
Upon resubmission, the cover page of the protocol must indicate that risk level is
"moderate."
Action on this protocol is deferred until the above issues are addressed. These concerns
will be communicated to the investigators. They will be asked to submit a revised
protocol for reconsideration.
4) Review of Protocol #0001-015.
The following issues were raised:
• The protocol dedicates a great deal of discussion to the measurement procedure using
the GaitRITE system. The Board feels this measurement procedure presents little
subject risk. However, the greatest potential subject risk inherent to the investigation
is via hippotherapy training, whose details are not presented in the protocol.
• The protocol and consent form must include a statement that the investigation will
follow the established standard safety and treatment protocols of the Little Bit
Therapeutic Riding Center.
• The investigators must identify the "licensed physical therapist" who will be conducting
the training, along with his or her experience and qualifications to conduct
hippotherapy with pediatric patients.
• What provisions are there if the child wants to stop riding the horse? These provisions
must be clearly communicated verbally and in the consent form.
• The investigators must specify how subjects are to be transported to the Woodinville
therapy site.
• The instructions of "Informed Assent" may be adjusted to the intellectual level of the
child. Investigators may use appropriate adult language with subjects of older
intellectual age.
• A letter of agreement to participate from the Little Bit Therapeutic Riding Center is
required and must be forwarded to the Board, prior to beginning the investigation,
along with copies of any consent forms, printed patient information, or printed
protocols that the Little Bit Therapeutic Riding Center either requires of, or provides
to participants and their parents or guardians.
• How will the investigators establish that the "child has a specific medical problem that
contraindicates horseback riding?" Does Little Bit Therapeutic Riding Center have a
standard screening form? The screening protocol, and/or forms, must be provided to
the Board.
Approved by voice vote of 9-0-0 (9 approved, 0 disapproved, 0 abstentions), pending
above corrections.
5) Ray Preiss reports that the Institutional Committee on Animal Care and Use is now in place.
6) Board Chair Ray Preiss will soon be preparing his annual report to the Faculty Senate on IRB
activity during the 2000-2001 academic year. He will be sending a request to all departmental
designates to provide a tally of protocols reviewed and approved at the departmental level over
the past year.
7) Given that protocols # 0001-013 and 0001-014 will require reconsideration following requested
modifications and that at least one additional protocol requiring full Board review is expected, the
Board will hold a final annual meeting in mid-May. The date and time will be arranged.
8) The meeting was adjourned at 4:07 PM.
Respectfully submitted,
Roger Allen, IRB secretary