Common
Human
Subjects Application
Problems
Completeness
of Information
Sometimes investigators
neglect to include
important information
without which the
Committees cannot
make an adequate
risk-benefit analysis.
Thus, it is extremely
important to include:
- A full
description of
approach and recruitment
procedures. If you
will contact prospective
subjects by telephone;
include a script or
protocol for the approach
call.
- A full account of
screening procedures,
and provide screening
materials (scripts,
protocols, data abstraction
forms, etc.).
- All available information
about investigational
and non-investigational
drugs, devices,
substances, and procedures.
- Examples
of health histories,
questionnaires,
activity diaries, standardized
tests, or instruments
to be administered
to subjects.
- Enough
information that
Committee members are
informed about what
will happen to subjects
and why the procedures
are necessary.
- Because
no procedures,
instruments or forms
are approved in general
or at large (they are
approved only in the
context of a specific
human subjects application),
those which you
intend to use must
be submitted for review
and approval. Only
materials that have
actually (a) been submitted
for review in connection
with a specific
application, (b) been
reviewed in connection
with that application
and (c) approved
in connection with
that application,
are actually approved
for use in connection
with the study covered
by that application
- and only in connection
with that application.
Materials that are
not provided cannot
be reviewed, and
cannot be considered
approved. Use of
such unapproved
materials or procedures
can constitute a breach
of the terms of
approval of a human
subjects application.
- Some researchers,
especially behavioral
researchers, use
audio or video
recordings as stimuli
(for example, audio
recordings of narratives,
or video from films).
These should be
submitted for review,
and for the application
record. Usually only
one copy is necessary.
At this time, one
of the most convenient
ways to submit
such material is to
burn a CD or DVD.
- If Grant Proposals
are connected with
the application, one
full copy of each must
be submitted with the
application. Without
the relevant grant
proposals, an application
cannot be sent for
review. Part of the
Committee's responsibility
is to certify that
what has been reviewed
and approved is
what is in the grant
proposal(s), and this
cannot be done if the
information is not
provided to the Committee
at review.
- If the application
is connected with
a Master's or
Doctoral thesis or
dissertation, one copy
of the thesis or dissertation
proposal must be submitted
with the application.
Without the proposal,
the application
can not be sent for
review.
Consent
Forms
Often consent forms omit
required elements of
informed consent and
are written in technical
language that subjects
do not understand.
Use everyday language;
avoiding technical
terms and professional
jargon as much as possible.
Use short words and
short sentences. Avoid
the passive voice.
Include consent forms
for all groups of adult
subjects, and assent
forms for minor subjects.
Include all required
elements of consent.
Copying
[Note:
this applies to paper
applications only.]
Sometimes investigators
try to save paper by
photocopying the application
and materials in double-sided
format. This makes
it is harder to review
documents, since one
cannot see both sides
of a page at the same
time. Second, if documents
are carelessly copied
in double-sided format,
one document often begins
on the back of another,
thus making it much more
difficult to process.
Thus, the Committees
do not accept double-sided
materials for review.
Formatting
Unusual fonts
should not be used in
human subjects applications.
Putting text in very
small type, into all
upper-case, or all underlined,
also makes it hard to
read, and is an unnecessary
burden on reviewers.
Similarly, putting the
responses to application
questions into a font
identical to that used
in the application form
can make it harder to
see where the question
stops and the answer
begins, especially if
the response text is
made to begin on the
same line as the end
of the question.
Privacy and Confidentiality
Problems in these areas
most commonly arise in
connection with how subjects
are approached to participate
in the research and how
the confidentiality of
data is protected.
- Approach
Subjects should be
approached to take
part in the research
by someone with whom
they have had prior
contact. This person
explains the study
briefly and requests
permission to release
the potential subject's
name to the investigator.
These so-called "intermediaries" may
include the subject's
health care provider,
teacher, friend, leader
of an organization,
etc. In many situations
in which prospective
subjects can reasonably
expect privacy, the
initial approach should
be made by someone
whom prospective subjects
will recognize as having
ordinary access to
their names and other
(confidential or otherwise
private) information.
- Confidentiality
of data should be protected
by removing direct
identifiers (e.g.,
names, addresses, telephone
numbers, social security
numbers, hospital numbers)
as quickly as possible
and by using secure
storage procedures.
The data storage procedures
one proposes to use
should be described
in the application.
In many studies, it
is important for investigators
to reflect on possible
limits to confidentiality,
and to address any
such limits both in
the application and
in the consent material.
Responsiveness
The purpose
of the human subjects
application is
to elicit relevant information,
in a specific order
and structure, that
allows reviewers to
read and comprehend
efficiently. Thus,
it is important to
fill out the form with
responses to the questions
that are asked. Two
examples include:
- Often,
putting "see
attached" under
questions or referring
to attached sheets,
undermines the purpose
of the form.
- Cutting and pasting
material from another
document that does
not specifically answer
the question after
which it has been inserted
can also confuse
rather than clarify.
Another important
aspect of responsiveness
is the timeliness
with which the
researcher responds
to communication
from the Committee
and staff. Some of
the most substantial
delays in application
processing are actually
found to be during
times when the Committee
is waiting for a
response from the
researcher before
it can proceed
with review or
approval. Translations
When any materials
(whether approach,
recruitment or consent
forms or procedures,
or questionnaires,
surveys or other
study procedures
or materials) are
to be administered
in a language other
than English, the
materials should
be submitted in the
target language(s),
accompanied by English
translation(s) that
accurately represent
the materials one actually
intends to use. The
following points
should be considered.
- Approach, recruitment
and consent materials
are often revised
as a result of review.
It is often better
to submit English
versions for initial
review, and explain
that translations will
be submitted after
English versions have
been approved. However,
because translation
sometimes requires
re-thinking and revision,
it may be that the
approved English
versions no longer
correspond to the actual
materials. If this
occurs, it is important
to submit new English
versions for review
and approval.
- Similarly, questionnaires
and interview material
to be used in several
languages may require
adaptations that
make each translation
a separate version.
In such cases, it may
be necessary to
submit an English translation
of each version.
Issues arising from
use of materials in
several languages
can become complex,
and must often
be handled on a
case-by-case basis.
When submitting an
application involving
use of translated
materials, it is
generally helpful
to address those
issues preemptively,
without waiting
to be asked about
them, in the application
itself. Addressing
the issues at the
time of application
can help reduce delays
in screening and
review.
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