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EDUCATION BULLETINS
Informed
Consent
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A clinic nurse tells you about a patient who may
be eligible for your study involving an investigational
drug for blood pressure. You and the nurse review
the patient’s medical history and determine that
this patient should be approached for the study.
Just before you go into the exam room, the nurse
mentions that the patient does not speak English
but his daughter who understands and speaks English
fairly well is with him in the exam room. You
grab the latest copy of the IRB approved consent
form and go into the room.
What more needs to be done?
The regulations require that subjects be provided
with information about the study in a language
that is understandable to them – this includes
providing a written consent form that is translated
into their own language whenever possible. The
PHRC provides a “short form” consent document
translated into many languages outlining basic
information about study participation but not
the details of a particular study. The PHRC strongly
recommends the use of hospital interpreters who
are familiar with medical terminology, especially
when a fully translated consent form is not available.
Other translators, such as family members, can
be used on a case-by-case basis. You should review
the PHRC
policy for obtaining consent from a non-English
speaking subject at our website before proceeding
further.
IRBs and Consultants
- You
have been informed that your new study is scheduled
for review in two weeks. You were told that this
delay in review is due to the IRB’s need to bring
in a consultant to assist in the review of your
new study. Can the IRB bring in outsiders to be
part of their review?
YES
The regulations allow an IRB at its discretion
to invite individuals with competence in special
areas to assist in the review of issues requiring
expertise beyond or in addition to that available
on the IRB. These individuals may not vote with
the IRB. The PHRC requires that consultants maintain
confidentiality about the studies they are asked
to review and document that they have no conflicts
of interest with any study they are asked to review.
Investigator
Responsibilities
- You
are a busy investigator. Over the past few years,
you have developed a really strong team of study
staff. This group really knows their stuff and
are capable of helping you set up a study, keeping
things on track, accurate data recording, you
name it. You want to take on a new study but are
really feeling stretched. You decide to delegate
many of your duties to your various study staff.
Is this okay?
Absolutely!
As the investigator you may delegate duties to
your study staff. However, you are responsible
for assuring that each member of the team understands
his or her responsibilities and is able to perform
them. Finally, you are responsible for the overall
conduct of the study, even if you are not doing
the day-to-day work. And don’t forget, Partners
QI team has developed a delegation
of duty log to assist with this process.
- You
just completed the close out visit with your sponsor.
You and your team did an excellent job and the
sponsor was very pleased. You are looking forward
to moving on to a new study. You’ve received a
notice that the study is due for continuing review
by the IRB but since the study is now complete
and you are no longer collecting data, you decide
that the recent notification for continuing review
can be tossed. You ball it up and sink it right
into the trashcan. Can you move on to your next
project?
NO!
PHRC policy requires that you submit a final report
on your study at the time of completion of the
study using the
continuing review form.
- You’ve
tried to get your continuing review paperwork
in on time but you were on service all month and
your patient load was exceptionally heavy. You
have just been notified that your study’s approval
has lapsed and you cannot do any research, not
even data analysis, until the IRB has re-approved
the study. Can they do this?
YES
If
an investigator has failed to provide continuing
review information to the IRB or the IRB has not
reviewed and approved a research study by the
continuing review date specified by the IRB, the
research must stop - unless the IRB finds that
it is in the best interests of individual subjects
to continue participating in the research interventions
or interactions. Enrollment of new subjects cannot
occur after the expiration of IRB approval. If
you have any subjects whose best interests will
be served by continuing to receive the study agent,
you should contact the IRB immediately. You’ll
need to submit a request to continue study procedures
on subjects already enrolled who have signed a
study consent form. Even when study activities
are limited to data analysis, you are required
to submit materials for continuing review and
approval by the IRB.
- You
are a very knowledgeable and highly experienced
investigator. You know the regulations. You have
noticed that lately the IRB is asking you to provide
a rationale statement for using pediatric patients
in your research projects. You know that ultimately
it is up to the IRB to determine whether or not
your pediatric patients are appropriately being
included in research. So, why are they asking
you?
IRBs
often rely on the investigator’s expertise to
obtain information and insight into particular
aspects of a study. Investigators often have
a degree of expertise that the IRB can draw
on during their review. You should feel flattered!
Recruitment
- You
are planning a study of a new decongestant. It’s
wintertime and you want to get the study done
at the height of cold and flu season. You have
IRB approval and have started the recruitment
process. Your recruitment efforts aren’t going
well so you decide to change your strategy. You
decide to recruit subjects from among the homeless
population in town and have designed an advertisement
for posting on telephone poles in an area where
a number of homeless men and women are known to
congregate. Because this is an intensive study
and requires 15 study visits in 5 weeks, you want
to appropriately compensate your study participants.
You decide to offer $1000 to each subject who
completes the study and make this the first line
in your ad. Can you post these ads immediately?
NO
There are several issues to consider here. First,
the IRB is required to review all recruitment
methods. In this case, the IRB needs to be informed
that you plan to recruit from the homeless population.
The homeless, as a group, could be considered
a “vulnerable population” and thus the IRB must
consider their involvement in the study as a special
issue. Secondly, the IRB must review all forms
of advertising. Also, current PHRC policy requires
that you NOT feature compensation before the description
of the study. Finally, the IRB will need to determine
whether or not $1000 could unduly influence these
potential participants and cause them to participate
in the study. Stop in at the IRB office before
proceeding.
- Your
new study will require advertising in the community.
You’ve prepared your advertisements for review
by the IRB. You are also drafting a telephone
screening script for your study coordinator to
use. What sorts of issues should you consider
regarding this screening script?
One
of the things you’ll want to do is to assure
that the script and your screening procedures
adequately protect the rights and welfare of
the prospective subjects. In some of these screening
situations, personal and sensitive information
is gathered about prospective subjects. You’ll
need to assure the IRB that any information
recorded during the screening will be appropriately
handled. A simple statement such as "confidentiality
will be maintained" does not adequately
inform the IRB of the procedures that will be
used. You might even consider issues such as:
- What
you do with personal information if the caller
ends the interview or simply hangs up;
- Whether
or not to ask the IRB (and individual callers)
if names of those found to be ineligible may
be maintained in case they would qualify for
another study. (The acceptability of your
study’s procedures will depend on the sensitivity
of the data gathered.)
Record Keeping
- You’re
the PI for a very busy study. While the pace has
been hectic, you’ve had good luck with enrollment
and are right on target. But - you haven’t been
able to keep up with some of the paperwork related
to the study. Some consent documents are missing;
you’re a little behind on collecting laboratory
results. Since these are mostly paperwork issues,
you’re not worried and know that eventually you’ll
find all the paper and get it organized. Should
you be worried?
YES!
Investigators are responsible for maintaining
study records, ensuring their accuracy and maintaining
their confidentiality. Even though you believe
you could pull all the information together, confidentiality
and accuracy are in question. This is not responsible
conduct of this research. The lack of documentation
would be a huge strike and could include ramifications
such as a report on the FDA Form 483, or monitor's
report.
- After
four years, you and your study team just completed
the close out visit with the study monitor for
your FDA regulated study. You are pleased with
the close out visit as it allowed you and your
team to demonstrate your great record keeping
practices. Now that the study’s completed and
the sponsor has completed the close out visit,
you’re ready to send all these records to the
shredder, right?
Not
quite
The
FDA requires that investigators maintain study
records “for a period of 2 years following the
date a marketing application is approved for
the drug; or, if no application is to be filed
or if the application is not approved for such
indication, until 2 years after the investigation
is discontinued and FDA is notified”. In addition,
Partners requires that study records be kept
for six years. Better hang onto these documents
for a few more years.
Remuneration
-
Your new study requires numerous blood draws,
as well as completion of 3 questionnaires. You
believe that these burdensome tasks require that
subjects receive some compensation for their time
on the study. You have limited study funds but
want to do something. You know a number of people
in the community and several businesses have offered
to donate gift certificates to you for use in
your study. Is this an acceptable practice?
YES
Whether
you purchase them from the company or receive
them as a donation, gift certificates are considered
an acceptable form of compensation for study
subjects. However, the IRB must first review
and approve the amount of the gift certificates
and your plans for distributing them.
Tracking
Disclosures of PHI for Research
- You
are collaborating with a colleague at an academic
medical center in Sacramento, CA. Your IRB approved
protocol allows you to collect data from medical
records and send it to your colleague. Your IRB
waived consent and authorization for this study.
You seem to recall that there are some special
additional procedures you need to follow for HIPAA.
Are you on the right track?
YES
The HIPAA Privacy Rule gives individuals the right
to ask for and receive an accounting of disclosures
(when shared outside Partners) of their protected
health information (PHI) made under a waiver of
authorization in the last six years. In order
to provide for such an accounting, all such disclosures
must be formally tracked. For research, tracking
must be completed if there is a waiver of authorization
for any disclosures of PHI to colleagues and collaborators
outside of Partners.
This
accounting should include: the date of the disclosure,
the name of the entity or person (and address
if known) who received the protected health information,
a brief description of the information disclosed,
and a brief statement of the purpose of the disclosure.
A sample of the tracking tool can be found here:
http://healthcare.partners.org/phsirb/hipaa/1_PH128_2.xls.
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