This school-based diabetes screening program is designed to identify youth with to publish findings on the efficacy of school-based screenings for diabetes. …
Sample IRB Letter
Approval
Mock Tribal Institutional Review Board
August 20, 1005
John Smith, MSN
The University
PO Box 71
University, SD 55555
Re: Pre-Diabetes and Diabetes on the Reservation: A School-Based Youth
Screening Program
Dear Mr Smith:
On August 15, 2005, the Mock Tribal Institutional Review Board IRB
reviewed the research proposal entitled, Pre-Diabetes and Diabetes on the
Reservation: A School-Based Youth Screening Program This school-based
diabetes screening program is designed to identify youth with undiagnosed
and asymptomatic diabetes at the Tribe The contingencies have been
addressed and the IRB approves the protocol Work on this project may
begin This approval is for a period of one year from the date of this
letter and will require continuation approval if the research project
extends beyond August 15, 2006
If you make any changes to the protocol during the period of this approval,
you must submit a revised protocol to the Mock Tribal IRB for approval
before implementing the changes Furthermore, if the results of the
research are used to prepare papers for publication or oral presentations
at professional conferences,
manuscripts or abstracts must be submitted to
the Mock Tribal IRB for pre-publication approval Results should be
reported to the tribe and the Service Unit involved
We appreciate your interest in providing the benefits of health research to
Northwest American Indian and Alaska Native communities If you have any
questions regarding the IRBs decision, please contact me at 555-555-5555
Sincerely,
Kevin Corrigan, Chair
Mock Tribal IRB
cc: Paul Wilson, co-Chair, Mock Tribal Institutional Review Board
Cassie Quinta, Primary Reviewer, Mock Tribal Institutional Review
Board
file
Sample IRB Letter
Approval with Contingencies
Mock Tribal Institutional Review Board
July 12, 2005
John Smith, MSN
The University
PO Box 71
University, SD 55555
Re: Pre-Diabetes and Diabetes on the Reservation: A School-Based Youth
Screening Program
Dear Mr Smith:
On July 12, 2005, the Mock Tribal Institutional Review Board IRB reviewed
the research proposal entitled, Pre-Diabetes and Diabetes on the
Reservation: A School-Based Youth Screening Program This school-based
diabetes screening program is designed to identify youth with undiagnosed
and asymptomatic diabetes at
the Tribe The screening will be conducted
among six schools on the Reservation and involve grade 3-12 IHS will use
the data to update medical records The PI is looking to publish findings
on the efficacy of school-based screenings for diabetes
After review, the IRB approves the protocol with the following
contingencies:
1 Clarify the time commitment and resource requirements of the
schools Address issues such as class disruption, impact on
teachers, cooks, school nurse, and PE teachers
2 Address what will be done with non-Indian students Will they be able
to participate in the screening?
3 If non-Indian students can participate, what will be done with their
data?
4 Clarify procedures for those parents/students who do not provide
consent:
o For parents/students who have declined prior to screening day,
what happens to those sitting in the classroom
o For parents/students who to decline on screening day
5 Address procedures for addressing potential harms due to labeling
For example, how will the Investigator handle labeling by others,
including parents, and self? Suggestions:
o
Checking only the neck for acanthosis nigricans may lead
children to compare necks of other students and make assessments
regarding diabetes, thereby inadvertently stigmatizing
individuals who the other students think have changes
characteristic of acanthosis nigricans The IRB suggests
checking other exposed parts to make it difficult for students
to make assessments
o Recruit experts for example, child psychologists and community
experts to assist the Investigator in the identification of the
harms of labeling and how best to handle these harms, keeping in
mind that children of different ages will most likely be
affected differently
6 Results of the screening should not be given to the students Results
should only be mailed to parents This is to prevent students from
talking to each other during the school day about their results and
causing undue worry and stigmatization
7 The protocol states that a followup telephone call will be made to
families The protocol should allow for contacting families that do
not have
telephones
8 The protocol states that all students testing positive for insulin
resistance, impaired glucose tolerance, or impaired fasting glucose
will be offered participation in a bi-weekly lifestyle intervention
classes Can the classes be offered to all students, whether or not
they participated as an educational opportunity for the
school/community?
9 Although the investigators state in the proposal that no personal
identifiers will be kept, the data collection sheet has DOB
10 Although there is a statement on data ownership, there is no
information regarding what will be made of the aggregate data The
protocol should state that information resulting from this study will
not be published in any form without the written permission of the
Tribal IRB, IHS Service Unit Director, and the Area IHS IRB
11 Missing elements on the consent form:
o Stated that students from the six reservation schools are being
recruited
o Include labeling as a possible harm in the consent form
o State that PIs intent is to publish results
o State expected duration of the students
involvement
o State the condition under which a research may terminate a
volunteers participation
o Include the tribal IRB contact name and number, Paul Wilson,
Mock Tribal IRB Chair, 555-555-5555
Work on the project MAY NOT begin until the above concerns are addressed
and reviewed by the IRB When revisions have been completed, please send
an updated copy of the research protocol for our review Please send all
correspondence to the Attn: IRB Coordinator, Mock Tribal IRB, 555 Mock
Road, Mockville, SD 55555
If you have any questions about the IRBs decision, please contact me at
555 555-5555 Thank you for submitting this research proposal to the
Mock Tribal IRB We appreciate your interest in providing the benefits of
health research to the Mock Tribe
Sincerely,
Kevin Corrigan, Chair
Mock Tribal IRB
cc: Paul Wilson, co-Chair, Mock Tribal Institutional Review Board
Cassie Quinta, Primary Reviewer, Mock Tribal Institutional Review
Board
file
Sample IRB Letter
Deferral
Mock Tribal Institutional Review Board
July 12, 2005
Mr Liam Neeson
Program Director
Exercise and Nutrition Foundation
PO Box
3364
Seattle, WA 98114
Re: 03-P-19 Indian Youth Exercise and Health Project
Dear Mr Smith:
On July 12, 2005, the Mock Tribal Institutional Review Board IRB reviewed
the research protocol entitled Indian Youth Exercise and Health Project
The overall purpose of this project is to conduct an exercise and diet
intervention among tribal youth to assess changes in their health as
related to cardiovascular disease
During the discussion, the IRB determined that the protocol required
additional detail and support documents and defers a final decision at this
time The IRB recognizes the importance of research surrounding youth and
cardiovascular disease
However, the IRB has critical concerns with the methodology of this
research project as proposed and its scientific validity to test the stated
hypotheses These concerns may even present a challenge to the ethical
soundness of this project The IRB requests clarifications and additional
information on the following issues of concern:
1 It appears that the hypothesis to be evaluated is that culturally
relevant diet and exercise regimens are superior to no exercise or
dietary interventions As the benefits of exercise and
improved diet
are well-established even in the specific population of AI/AN teens,
the IRB has concerns about the ethics of enrolling control
participants to explicitly exclude them from exercise and diet
interventions If it is the cultural relevance of the intervention
that is being evaluated, perhaps a more appropriate design would be to
compare a culturally relevant program to a standard, non-culturally
based program Please address this concern
2 The IRB has strong reservations about the ability of investigators to
adequately assess for misclassification between the two groups A
short survey administered two times separated by twelve months does
not seem sufficient to assess whether the control subjects may have
also increased their exercise or changed their diets More generally,
there appear to be so many possible confounders not addressed by the
survey that drawing conclusions about the efficacy of the intervention
based on the information to be gathered could lead to incorrect
conclusions Some of these include parental involvement in dietary
choices, economic factors affecting
behavior, medical factors
affecting weight or activity, etc
3 The emphasis of the proposal is cultural-relevance, but the protocol
does not provide what this entails in terms of exercise and diet In
addition, our tribes is made up of many clans, so the mix of cultures
may be varied such as to make any intervention very difficult to make
culturally relevant to all participants Please provide details on
the interventions
4 A selection methodology that allows subjects to choose whether to be
in the intervention or control group is fundamentally flawed and makes
any conclusions drawn suspect It seems intuitive that more active
youth may choose to be in the intervention group, whereas sedentary
youth the controls, introducing a high degree of confounding factors
5 The IRB felt that the methodologies for measuring the outcomes of
interest seem insufficient One measure of Body Mass Index, blood
pressure, dietary recall and physical activity habits separated by
twelve months seems inadequate to evaluate the intervention, given the
high degree of variation in these measures over very short time
periods In particular the weight, fitness test and the 24-hour
dietary recall as this information may differ greatly from day-to-day,
and blood pressure from minute to minute Please address whether the
validity of these measures can be improved perhaps greater frequency
of measurement, etc Alternately, if data are truly lacking in the
area of cardiovascular risk factors in AI/AN youth, perhaps collecting
adequate baseline data should be the focus of this phase of the study
6 Please describe the characteristics of the control group, ie, are
they restricted from participating in the interventions? If not, when
are they eligible any time or six or twelve months? If a participant
in the comparison group begins to jog daily on their own, will they be
terminated from the comparison group? Will they also receive
compensation?
7 Parental consent for these minors is not optional It must be
obtained prior to enrolling their child in the study In addition, the
consent form needs to make clear the possibility that the child may be
randomized to a control group and explain exactly what this entails
Though the interventions proposed are generally low risk, there is
risk of sedentary children starting to exercise, and any intervention
in children needs parental consent
8 Provide details on the parents involvement in their childs
participation throughout the research project The IRB feels that
this may represent a major source of confounding, as well as a major
opportunity for education of families on the dietary and exercise
interventions
9 Is the medical follow-up of subject participants adequate? Again,
sedentary children starting to exercise face a not insignificant
injury risk Please address this
10 Provide the calculations undertaken to reach a sample size of 60
youths Is this sample size based on estimated prevalence of any of
the risk factors?
11 Provide a copy of an assent form Youth under the age of 18 must sign
an assent form prior to participation
12 Provide information on the economic burden to participants, including
transportation to and from the twice-a-week sessions Provide this
information, as applicable, in the consent form
13 Provide references on the validity
of the fitness test proposed
14 Clarify where and to whom results of the research project will be
reported All reports should be submitted to the IRB for review prior
to dissemination
15 Essential elements from the consent form are missing Please include
the following in the consent form:
a Clearly state that this project is research
b State how and why prospective volunteers were selected
c Clearly state the expected duration of the volunteers
involvement
d Provide details on the times and dates that participants will
have to be available for the sessions
e State that the participant may quit at anytime
f State the consequences for a participants early withdrawal from
the project
g State under what circumstances a researcher may terminate a
volunteers participation
h Provide information in the case of injury to a participant
i State compensation for injury to a participant
j Include a toll-free 1-800 IRB contact for inquiries regarding
human subjects protections The Portland Area IHS IRB Chair,
Francine Romero,
telephone number 1-877-664-0604, may be listed
as a resource for participants
k Include a non-coercion disclaimer, for example, Taking part is
voluntary You may refuse to take part without any penalty or
loss of care or services by the Seattle Indian Health Board or
others You may quit at any time, without penalty or loss of
care or services for which you are qualified
l Provide a copy of the signed consent form to the parent
16 Make sure that all information included in the consent form is
included as procedure in the text of the protocol and vice versa
17 Provide background information for the Principal Investigator,
including a curriculum vita
18 Provide background information for the cultural advisor, including a
curriculum vita
19 Provide background information for the nutritionist, including a
curriculum vita
20 If this is a grant-funded project, provide a copy of the grant
announcement
21 Provide additional information on the youth group from which
participants will be recruited Include information on the
demographics of youth currently involved,
when they meet, and types of
activities conducted as a group
Despite the significant concerns expressed above, the IRB encourages your
work in the area of AI/AN youth and cardiovascular disease Dr Kim
Morgan, MD IHS Service Unit Clinical Director, who acted as Primary
Reviewer for your proposal, has indicated that she would be willing to
discuss the IRB concerns with you and provide feedback or assistance on
modifying this project, if desired She can be reached at 555-555-5555
In addition, Ms Cassie Quinta of the Mock Tribal IRB and member of Clan A
has also volunteered her time in identifying culturally relevant
intervention programs and can be reached at 555-555-5555
Work on the project MAY NOT begin until the above concerns are addressed
and reviewed by the IRB When revisions to your protocol have been made,
please send an updated research protocol for our review Please send all
correspondence to Mock Tribal IRB
We appreciate your interest in providing the benefits of health research to
northwest American Indian and Alaska Native communities If you have any
questions regarding the IRBs decision, please contact me at 555-555-5555
Sincerely,
Kevin Corrigan,
Chair
Mock Tribal IRB
cc: Paul Wilson, co-Chair, Mock Tribal Institutional Review Board
Kim Morgan, MD, Primary Reviewer, Mock Tribal Institutional Review
Board
file
Sample IRB Letter
Disapproval
Mock Tribal Institutional Review Board
July 12, 2005
Mr Liam Neeson
Anthropology Dept
The University
PO Box 3364
Seattle, WA 98114
Re: Food and Obesity Study
Dear Mr Smith:
On July 12, 2005, the Mock Tribal Institutional Review Board IRB reviewed
the research protocol entitled Food and Obesity Study The overall
purpose of this project is to assess whether there is a relationship
between obesity and tribal members beliefs regarding traditional foods and
contemporary foods
During the discussion, the IRB determined that the research does not fit
within our tribal priorities at this time and disapproves this research
Traditional foods for our tribe is considered to be a part of our private
tribal knowledge Your intentions to interview tribal members, including
elders, to document our traditional foods is against our tribal policies
We recognize your intentions to improve the health of our tribal members
However, work on the project is prohibited on our
tribe and tribal members
If you have any questions regarding the IRBs decision, please contact me
at 555-555-5555
Sincerely,
Kevin Corrigan, Chair
Mock Tribal IRB
cc: Paul Wilson, co-Chair, Mock Tribal Institutional Review Board
Kim Morgan, MD, Primary Reviewer, Mock Tribal Institutional Review
Board
file
Source:cap.org
