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CRITIERIA FOR APPROVAL OF RESEARCH – 45 CFR 46.111
1. Risks to subjects are minimized: (i) By using procedures which are consistent with
sound research design and which do not unnecessarily expose subjects to risk, and (ii)
whenever appropriate, by using procedures already being performed on the subjects
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
and the importance of the knowledge that may reasonably be expected to result. In
evaluating risks and benefits, the IRB should consider only those risks and benefits that
may result from the research (as distinguished from risks and benefits of therapies
subjects would receive even if not participating in the research). The IRB should not
consider possible long-range effects of applying knowledge gained in the research (for
example, the possible effects of the research on public policy) as among those research
risks that fall within the purview of its responsibility
3. Selection of subjects is equitable. In making this assessment the IRB should take into
account the purposes of the research and the setting in which the research will be
conducted and should be particularly cognizant of the special problems of research
involving vulnerable populations, such as children, prisoners, pregnant women,
mentally disabled persons, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally
5. Informed consent will be appropriately documented, 6. When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and
to maintain the confidentiality of data.
8. When some or all of the subjects are likely to be vulnerable to coercion or undue
influence, such as children, prisoners, pregnant women, mentally disabled persons, or
economically or educationally disadvantaged persons, additional safeguards have been
included in the study to protect the rights and welfare of these subjects.
Two business professors, Milkman and Akinola wished to see if "students from underrepresented groups" (presumably racial and ethnic minorities, and perhaps women) would be less likely to gain the interest of doctoral faculty than "other students" (i.e., white guys). Emails were sent to 6300 professors in PhD-granting departments at American universities. The messages, purportedly from a student planning to apply to PhD programs and wishing for a brief meeting, varied by the name of the student and by the time of the proposed meeting. When a professor answered, they replied to cancel the meeting. The idea was to see if students with white-guy names received more or fewer invitations to meet than others. Names of students sending the email were very clearly white, African-American, Chinese, Indian, etc. A few days after receiving the initial email, a debriefing e-mail was sent to all 6,300 professors explaining the sham. Questions:
1. Is this study approvable per 45 CFR 46.111? 2. Is it appropriate to waive consent for this study?
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
An FDA approved drug (approved in both adult and pediatric populations) is proposed by an
investigator to be studied for a new indication. The indication is for an orphan disease, and will
involve only pediatric subjects (the population this disease most commonly occurs within). The
eligibility criteria for the study includes both boys and girls, however the investigator has
decided to exclude girls 12-20. Boys age 2-20, and girls age 2-11, are included.
The justification for the exclusion provided by the PI is that the indication under study is more
frequent in boys than girls (approximate ratio of 3 boys for every 2 girls), that the risks to a
potential fetus are unknown, and thus girls of child-bearing potential should be ineligible.
However the drug is FDA approved (for other indications) for pediatric subjects down to age 2,
and is Pregnancy Category B. The impression of several IRB reviewers is that the PI simply does
not want to deal with a pregnancy test or counseling in the 12-20 year old female population to
1. Would you consider this to be in violation of “equitable selection of subjects” and
2. Is the exclusion of girls older than 11 justifiable?
3. Is this study approvable per 45 CFR 46.111?
ASU researchers collected blood samples from members of the Havasupai Indian Tribe, in the
1990s, for research on diabetes. All the research subjects who provided blood also provided
documented informed consent. The consent form stated that the blood would be used for
research on the causes on “behavioral and medical disorders.” However, discussions about the
project, with tribal leaders, focused on diabetes.
Scientists would now like to use the blood samples for research on mental illness and theories of
1. Does this require an additional consent?
2. Can the samples be used for these research studies under the current consent as
1. Harmon, Amy. “Indian Tribe Wins Fight to Limit Research of Its DNA.” New York
2. Mello, Michelle M, J.D., and Wolf, Leslie E, JD, MPH. “The Havasupai Indian Tribe
Case – Lessons for Research Involving Stored Biologic Samples.” The New England Journal of Medicine, 363 (2010); 204-207.
In 2010, an oncologist at NS-LIJ submitted a new study for IRB approval. The study is sponsored by the National Cancer Institute and is titled:
NSABP P-5: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer
The purpose of this study is to determine the effectiveness of an FDA approved statin drug (Crestor) for reducing recurrence of colon cancer in patients with a history of early stage colon cancer. Reports of people who take statins to lower cholesterol suggest that statins may also lower the risk of certain cancers developing, including cancers of the colon or rectum. So this study will investigate if Crestor can be effective in lowering the risk of colorectal cancer recurrence.
Patients are randomized to receive either placebo or Crestor for 5 years (50% chance of receiving statin). The study is double-blinded, meaning neither the patient, nor their physician will know which drug (Crestor or placebo) the patient is receiving.
During the initial IRB review, members noted that the study eligibility criteria does not allow enrollment of anyone who has used a statin within 30 days of randomization. Reviewers questioned if the study will be able to enroll enough subjects, given that presumably the vast majority of these patients would already be on statins for cholesterol. Nonetheless, the study was IRB approved.
It’s now 2 years later. You are sitting on the IRB and the study team has submitted its
continuing review application.
As expected, accrual to the study is very slow. Locally, only
one patient has been enrolled. Nationwide, 158 subjects (out of a study wide goal of 1740) have
been accrued. The study opened to enrollment nationally in 2010, and the protocol estimated
that 40 subjects would be enrolled each month, completing enrollment in under 2 years. At the
current rate, it will take 22 years to complete enrollment.
1. Would you re-approve this study? 2. How does low enrollment affect the risks to subjects, if at all? 3. Is it the IRB’s business to look at enrollment numbers? 4. If it takes 22 years to achieve results, is that too long?
A B S T R A C T Objective To find out efficacy of laparoscopy in evaluation and treatment of chronic pelvic pain (CPP) ingynecologic patients in terms of arriving at diagnosis. Study design Place & Department of Obstetrics and Gynaecology Baqai Medical University Karachi, from July 2006 Duration of study Patients and A total of 30 patients were selected
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