Institutional Review Board Minutes
December 4, 2000
Members Present: Allen, Finney, Ferrari-Comeau, Kay, Lamb, Preiss, Stewart, Wadsworth,
Woodward.
This IRB meeting was opened at 2:00 PM in room 326 of Wyatt Hall.
1) Minutes from the 11/6/00 meeting were approved, with one typographical correction, by a voice
vote of 9-0-0 (9 in favor, 0 opposed, 0 abstained).
2) New business - Protocols reviewed
#0001-006
The following issues were discussed:
• Is there a potential risk to participants of losing child custody if videotaped results of the
study were to be subpoenaed? The suggestion was offered that videotapes of
mother/child interactions be erased or destroyed immediately following their use in
the study and after providing the subject the opportunity to view it at the second
research session. The option was also suggested to give the videotape to the
subject, if she wished it, and if it would not violate institutional protocols.
• Concern was expressed that "generalized" results reported back to supervisors may
actually be identifiable to a particular subject, given that only three subjects are
proposed to participate in the study.
• A number of issues related to the consent form were raised. The form should clearly
specify that there will be no loss of rights or privileges if the subject discontinues or
does not choose to participate in the study. The right to refuse to participate must be
clearly articulated. The "risks" section must include the potential risk of study findings
being subpoenaed.
• Contact information for the UPS Associate Dean's office should be provided in the form
of a mailing address.
• Investigators should discuss with institutional supervisors that there are to be no
institutional risks or benefits associated with participation, lack of participation, or
discontinuation.
• If the experimental protocol is significantly altered, a revised protocol must be submitted
to the IRB for further review.
Project approved by voice vote 9-0-0 (9 in favor, 0 opposed, 0 abstaining)
#0001-007 & 0001-008
It appears these two protocols represent two separate student investigators working
together on the same study. However, it is unclear as to whether each protocol
represents a separate component of that study. They were reviewed by the board
simultaneously.
The following issues were discussed:
• The protocols refer to the establishment of a "behavioral contract" with the subject. No
document of this type was provided in the protocols submitted to the Board. Does
this behavioral contract negate the subject's right to discontinue participation at any
time?
• Will post CVA subjects be able to comprehend the language of the consent form. Are
there provisions for informed consent with subjects manifesting receptive aphasia?
Is this an exclusion criterion?
• Much more specific information is needed regarding screening criteria on issues such
as medical stability and cognitive or proprioceptive impairments.
• Protocols are unclear as to whether a "sling" will be used in addition to the resting hand
splint.
• The investigators must provide recruitment letters to the IRB for review.
• The investigators must compose, and provide for participants, a page of early warning
signs regarding potential problems caused by the resting hand splint.
• The consent forms for the two protocols are not the same. If this is the same study,
using the same participants, the investigators must provide the single, actual consent
form that will be used.
The Board will take no action on either of these two protocols, at this time, pending
clarification of the above issues.
#0001-009
The following issues were discussed:
• Investigators should articulate what specific "health concerns" could interfere with
implementation of the protocol.
• The protocol, as written, is unclear as to what the age range of the participants is
intended to be. Specifically will sampled participants be 2-12, or 6-12 years of age.
• The consent form must provide a more complete description of the touching
intervention.
• Language modifications to the consent form were discussed and will be communicated
to the investigator via letter from the IRB chair.
Project approved by voice vote 7-0-0
#0001-010
The following issues were discussed:
• The protocol, as written, is unclear as to what the age range of participants is intended
to be.
• How does the investigator define "sound mental and physical condition" for fathers and
why is this an issue? Is there a proposed screening instrument to make this
determination, or should this inclusion criterion be eliminated?
• More specificity is warranted on sources accessed to nominate participants.
• Language adjustments to consent form, in the interest of clarity to the potential subject,
were suggested and will be communicated to investigators in their letter from the IRB
chair.
Project approved by voice vote 7-0-0
#0001-011
The following issues were discussed:
• Are there actually "no risks" to subjects associated with the interview questions?
• Is the investigator making potentially erroneous assumptions regarding Catholicism,
which might color interpretation of findings, or potentially offend participants?
• Could there exist personally sensitive issues that will be raised by the interview?
• Is it necessary, or what purpose is served, by videotaping subject responses to
interview questions?
The Board has elected to take no action on this protocol, at this time, pending receipt of
additional information.
3) Ray Preiss circulated to board members the draft of an informative letter to department chairs,
articulating IRB practices. He invited comments on this draft to be presented at the first meeting
of the Spring 2001 semester.
4) The meeting was adjourned at 3:23 PM.
Respectfully submitted,
Roger Allen, IRB secretary