Madam Chairman, I offer an amendment. Madam Chairman, today I offer an amendment cosponsored by Congressman Tom Cole, Congressman Bobby Scott, and Congresswoman Carol Shea-Porter that will prohibit funds from being used to carry out a…
Madam Chairman, I offer an amendment.
Madam Chairman, today I offer an amendment cosponsored by Congressman Tom Cole, Congressman Bobby Scott, and Congresswoman Carol Shea-Porter that will prohibit funds from being used to carry out a damaging, unethical Education Department proposed evaluation of a TRIO program, the Upward Bound program.
This amendment will put a halt to this unethical study that deceives students and their families, takes away critical opportunities for them, and sets the program up for failure. This same language is included in the higher education reconciliation bill.
I thank Members from both sides of the aisle for rebuffing the Education Department's repeated, relentless efforts to kill the TRIO Upward Bound program over the past 2 years. Because of the adamant congressional resistance, the Department has now decided that they can simply study the program to death. This is an unethical program.
Madam Chairman, I submit for the Record three letters from highly respected institutional review boards that indicate that this is an unethical program and also a letter from 15 highly respected educational associations deeming the study unethical. The FDA regulates these institutional review boards, and it's precisely to protect human beings who are subject to human experimentation.
memorandum
To: Dr. Beverly Simone, President, Southeastern Community
College
From: Rebecca S. Rump, Chair, SCC IRB
Date: June 8, 2007
Re U.S. Department of Education Upward Bound Research of
Higher-Risk Students
Following evaluation and consideration of the U.S.
Department of Education's project, ``Impact Evaluation of
Upward Bound's Increased Emphasis on Higher-Risk Students,''
Southeastern Community College's Institutional Review Board
would like to express its concerns with this research and our
involvement with the project.
Although we expect that our College's Upward Bound program
staff will continue to work with the U.S. Department of
Education and the evaluation project, our initial concern is
that potential participation in Upward Bound (UB) requires
students to participate in the evaluation study. For those
students and families who do not want to participate in the
study, they can complete forms indicating that decision. Yet,
they are still entered into a lottery in which they may not
be chosen for UB. The design of the study (with UB very
likely serving fewer students due to half of the students
being assigned to the control, group) inherently denies
services to students that they otherwise would likely receive
without the study being conducted. In essence, we question
the validity and ethical foundation of a study which induces
a negative impact on the program being studied.
Closely related to the fact that this study is not
ultimately voluntary is the fact that the control group will
only receive token monetary compensation as opposed to the
benefits of Upward Bound (UB) despite having participated in
the study to the same degree as the experimental group. In
essence, by participating in the study some students will not
have the opportunity to participate in UB. The project's
research design is similar to other experimental-control
group designs in which one group is denied a treatment in
order to determine the treatment's effect. Typically in such
research if the treatment is effective, the control group is
immediately given the treatment as an ethical consideration
for their being placed randomly in the control group. In the
current project, the treatment is the Upward Bound program
itself. Students in the control group will not be able to
participate in UB due to age considerations after the study,
and as the study stands, there is no plan to provide any
educational program equivalent to UB after the study to the
students in the control condition. Unfortunately,
participants who are randomly placed in the control condition
and not admitted to UB are not given equivalent compensation
to those who are selected to participate in UB. Participants
in the control condition wilt be given monetary compensation
that simply does no equal the educational and personal
benefits of participating in UB. Such inequity simply is not
within the realm of ethical treatment of research
participants.
Finally, our last concern relates to the language level
used in the materials that parents of participating UB
students must complete. We presume that many of those parents
read at levels below high school. Requiring completion of
these materials may discourage participation in the program,
a
most unfortunate result for the prospective UB participants.
The IRB appreciates the purpose of Upward Bound and
understands the institutional decision to participate in the
study, but we want you to know our concerns with respect to
this research. As always, we appreciate your consideration of
our position and your support of ensuring the integrity of
research at Southeastern Community College.
Central College
Pella, IA, May 14, 2007.
memorandum
To: Dr. Paul Naour, Provost
From: Dr. Keith Jones, Institutional Review Board Co-Chair
Re U.S. Department of Education Upward Bound Research of
Higher-Risk Students
Date: May 14, 2007
Following evaluation and consideration of the U.S.
Department of Education's project, ``Impact Evaluation of
Upward Bound's Increased Emphasis on Higher-Risk Students,''
the Institutional Review Board would like to express its
concerns with this research and our involvement with the
project.
Our initial concern is that potential participation in
Upward Bound (UB) for all intents and purposes requires
students to participate in the study. For those students and
families who do not want to participate in the study, they
can complete forms indicating that decision. Yet, they are
still entered into a lottery in which they may not be chosen
for UB. The design of the study (with UB very likely serving
fewer students due to half of the students being assigned to
the control group) inherently denies services to students
that they otherwise would likely receive without the study
being conducted. In essence, we question the validity and
ethical foundation of a study which induces a negative impact
on the program being studied.
Closely related to the fact that this study is not
ultimately voluntary is the fact that the control group will
only receive token monetary compensation as opposed to the
benefits of Upward Bound (UB) despite having participated in
the study to the same degree as the experimental group. In
essence, by participating in the study some students will not
have the opportunity to participate in UB. The project's
research design is similar to other experimental-control
group designs in which one group is denied a treatment in
order to determine the treatment's effect. Typically in such
research if the treatment is effective, the control group is
immediately given the treatment as an ethical consideration
for their being placed randomly in the control group. In the
current project, the treatment is the Upward Bound program
itself. Students in the control group will not be able to
participate in UB due to age considerations after the study,
and as the study stands there is no plan to provide any
educational program equivalent to UB after the study to the
students in the control condition. Unfortunately,
participants who are randomly placed in the control condition
and not admitted to UB are not given equivalent compensation
to those who are selected to participate in UB. Participants
in the control condition will be given monetary compensation
that simply does not equal the educational and personal
benefits of participating in UB. Such inequity simply is not
within the realm of ethical treatment of research
participants.
The IRB understands the institutional decision to
participate in the study, but we want you to know our
concerns with respect to this research. As always, we
appreciate your consideration of our position and your
support of ensuring the integrity of research at Central
College.
The University of Utah
Salt Lake City, UT, June 13, 2007.
Kathryn S. Felker,
Director, Educational Opportunity Programs, University of
Utah, Salt Lake City, UT.
Dear Ms. Felker: I am the Associate Vice President for
Research Integrity at the University of Utah. The University
of Utah Institutional Review Board (IRB) provided me with
information regarding the U.S. Department of Education's plan
to evaluate the Upward Bound program. My understanding is
that the study has been deemed exempt from local IRB review.
Normally our IRB would make that determination and would not
defer that responsibility to external agencies. Nevertheless,
the study would appear to be exempt under Category 5 of the
federal regulations 45 CFR 46. While the IRB will not exert
oversight authority for this research, IRB staff have raised
a number of concerns about the conduct of this study.
After reviewing this information, I also will express my
concerns over the study design. Recruitment of twice as many
eligible students than can be served and randomly assigning
applicants to intervention and control groups raises serious
ethical issues. Assuming this well-established program has
shown some evidence of benefit in past assessments,
assignment to the control group would deny those benefits,
but only after an extensive application process and the
development of a relationship with program staff. Then to
deny even the possibility of obtaining services from the
Upward Bound program in the future may compound the harm and
preclude services for which they would otherwise be eligible.
Surely there is a better way to conduct an assessment of the
program.
The DOE will continue to collect data on the educational
outcomes of the children in the control group, although they
will not be receiving any services from the program. Further,
the consent forms do not indicate an ability to withdraw from
the study.
Studies with non-intervention control arms always receive
close scrutiny by the IRB because of their ethical
complexities. It is incumbent on the investigators to
demonstrate that this study design minimizes risks of harm
and that other research designs are not feasible. Of course,
I was not involved in the discussion over this research
design, but it seems highly probable that other approaches
could be used to assess the value of the Upward Bound
program. I strongly encourage a reassessment of the conduct
of this research.
By way of credentials, I will note that I currently serve
of the DHHS Secretary's Advisory Committee on Human Research
Protections (SACHRP) and so have extensive experience with
research ethics and federal regulations governing the
protection of human subjects.
Please relay our concerns to the DOE and other federal
officials who are involved in governing this project.
Best regards,
Jeffrey R. Botkin, M.D., M.P.H.,
Professor of Pediatrics and Biomedical Ethics, Associate
Vice President for Research Integrity.