Institutional Review Board Minutes
May 9, 2000
Members Present: Allen, Finney, Lamb, Moore, Preiss, Wadsworth, Weinman, Wells
The final regular IRB meeting of the 1999-2000 academic year was opened at 10:03 AM in the
McCormick room (312) of Collins Memorial Library.
1) Research Protocols Reviewed
#9900-015
The following issues were discussed:
The investigators must solicit a permission letter from any grocery store whose clerks will be participating in the study while at the worksite, agreeing to serve as the experimental treatment site.
The investigators should develop a screening questionnaire (or standardized interview) which will determine if the potential subjects meet any of the exclusion criteria stated in the protocol. Screening questions may group exclusion criteria together so that potential subjects need not disclose what specific exclusion factors or behaviors they may manifest. Given that if a potential subject is excluded from participation, there will be no reason for maintaining his/her responses, any such record made of subject responses to exclusion criteria will be immediately destroyed.
The consent form uses quite directive language. It is recommended that definitive phrases such as "you will" be changed to wording such as "you will be asked to."
It is recommended that upon completion of the study, subjects be permitted to keep both magnetic and nonmagnetic insoles, and that the consent form be modified to state this.
Approved by a voice vote 8-0-0 (8 in favor, 0 opposed, 0 abstention)
#9900-016
The following was recommended:
The investigators determine and inform the Board of the contents of the "nontoxic" substance" which will be applied to the subjects' feet to mark their footsteps.
Approved by a voice vote 8-0-0 (8 in favor, 0 opposed, 0 abstention)
#9900-017
The following areas of concern were discussed:
The incontinence screening questionnaire includes potentially quite sensitive medical information. This information is essential background for the treating therapist, but is not required to address the questions of the proposed research study. It is therefore recommended that the only information gleaned from the screening questionnaire, shared by the therapist with the researchers, is whether or not the patient/subject meets criteria for inclusion in the study.
It is recommended the exclusion of "non English speaking" be eliminated. The cooperating medical facility is required by law to treat non English speaking patients and provide interpreters. It is therefore feasible, within current medical practice, and reflective of the population as a whole to eliminate this exclusion.
The telephone number for the office of the associate dean should be corrected on the consent form.
Approved by a voice vote 8-0-0 (8 in favor, 0 opposed, 0 abstention)

#9900-018
The following areas of concern were discussed:
The consent forms need thorough revision. Specific recommendations include attenuating sensational claims of benefits, presenting the name of the investigator with greater prominence, and working with the project advisor to achieve greater accuracy of language and expression.
The Board requests the investigator solicit and submit to the Board a letter from Bridges, describing the nature, content, and limitations of the "32 hour" training program as well as a description of the psychological support systems in place in the event the researcher triggers acute psychological trauma in a child.
The Board also requests a letter from the daycare facility, agreeing to serve as the testing site.
IRB decision will be made upon receipt of the requested letters, modifications, and revisions.
#9900-019
The following was recommended:
Any outside institution providing research subjects (i.e. Green River Community College or Tacoma Community College) must supply a letter agreeing to allow the investigators to solicit potential research subjects from that institution.
Revise item #5 on the questionnaire, clarifying the term "aroused," to eliminate sexual innuendo.
Revise line 2 of the description on the consent form to simply "you will rate the people depicted in the video."
Approved by a voice vote 8-0-0 (8 in favor, 0 opposed, 0 abstention)
#9900-020
The following was recommended:
The telephone number for the office of the associate dean should be corrected on the consent form.
Approved by a voice vote 7-0-1 (7 in favor, 0 opposed, 1 abstention)
#9900-021
The following issues were discussed:
Will subjects be screened for knee injuries?
Who will be the massage therapist?
Will the therapist be trained in lymphatic drainage? If so, will he/she be employing these techniques in the study? If not, would he/she be open to receiving initial training in these techniques prior to treating the experimental subjects?
Minor corrections and modifications to the protocol were proposed and will be provided to the investigators.
Approved by a voice vote 7-0-1 (7 in favor, 0 opposed, 1 abstention)
Kathie Hummel-Berry's email was circulated regarding dissemination of teaching evaluation data collected by ASUPS. The specific issues raised will be discussed by the Board next Fall.

Additionally, the board will include ASUPS in next Fall's activities to educate the campus community regarding human subjects, survey, and research issues.
The Board will meet ad hoc during the Summer to review revisions related to protocol #9900-018.
The meeting was adjourned at 11:14.
Respectfully submitted,
Roger Allen