Institutional Review Board Minutes
October 11, 1999
Members Present: Allen, Finney, Holland, Lamb, Moore, Preiss, Wadsworth, Weinman, & Wells
The meeting was opened at 9:02 AM in the McCormick room (312) of Collins Memorial Library.
1) Minutes of the 9/16/99 meeting were approved by voice vote.
2) Research Protocols Reviewed
#9900-002
Baker, Williams, Brown, Dunbar, Gaskin, Hirsch, Poucel, & Wait
The following areas of concern were discussed:
a. Concern was raised over patient selection and risk protection for a metabolically
compromised patient. It was mentioned that this is a single case design, the patient in
question has been specifically referred to physical therapy by a physician, activities with
the patient are part of standard physical therapy practice for the condition, the patient has
previously been treated by on-site physical therapists in a similar manner and for similar
duration, and the patient and family are interested and enthusiastic about study
participation.
b. Numerous grammatical errors were present in the proposal.
c. Plan for erasing videotapes of patient. It was brought up that patients, or their
parent/guardians, sign a photographic consent document which authorizes any clinical
photography to be used in the future, at UPS, strictly in the context of clinical education.
Approved by a vote of 7-0-1 (7 in favor, 0 opposed, 1 abstention)
#9899-008
Pendley, Tiernan, & McGruder
The following areas of concern were discussed:
a. Clarify the two blanks present in line 6 of the "Description" paragraph of the consent
form.
b. Clarify whether there will be 16 or 32 sessions for each subject (with and/or without
cuff weights).
c. The issue of the potential risk of increased tremors secondary to cuff weight use was
discussed. It was pointed out that this concern is speculative, without experimental or
observational findings to support the concern, and that this treatment technique is
frequently utilized in routine therapeutic settings.
Approved by a vote of 8-0-0
#9900-003
Kendrick & Sanhow
The following areas of concern were discussed:
a. No advisor letter. The board determined, by consensus, that all student research
project IRB proposals must include a letter of support from the instructor/advisor, in
addition to the instructor/advisors signature on the IRB cover sheet.
b. Clarify in paragraph A of pg. 2 whether investigators are assessing "self-esteem" or
"self-competence".
c. Consent form should delete the term "however" from line 1 of the sections "Risks and
Benefits".
d. Replace the word "farce" with another choice, from paragraph 2 of the debriefing form.
Approved with modifications by a vote of 9-0-0
#9900-004
Staffield, Gula, & McKenna
The following areas of concern were discussed:
a. Clarify the actual number of subjects, or modify cover page to state n = 48-60.
b. Several grammatical corrections to the proposal are warranted.
Approved by a vote of 9-0-0
#9900-005
McNeley, Dobney, & Harris
The following areas of concern were discussed:
a. Significant concern was raised over subject recruitment protocol, which specifically
requires subjects to self identify as "heterosexual" on a sign-up board posted in a public
setting. The board expressed a desire to review the sign-up form prior to final approval.
b. "Benefits" section of the consent form needs to be modified to clarify that the study will
attempt to seek further understanding of heterosexual female attitudes toward
homosexuality.
c. The debriefing form must define "confederate" and indicate that there was, in fact, no
such campus incident as what was described.
d. The first line of the debriefing form must state that the study was actually investigating
conformity.
e. There was significant concern among board members that the study potentially placed
a vulnerable population group at risk by presenting fabricated information without
adequate or full disclosure in the debriefing. To the debriefing page, the phrase, "this is
not factual material" must be added.
Approved with modifications by a vote of 9-0-0
3) Due to time constraints, it was determined that the issue of animal research oversight would
be deferred to a future meeting.
The meeting was adjourned at 9:50.
Respectfully submitted,
Roger Allen