Approaching
Prospective Subjects
Prescreening Records
Pre-screening is any activity by which the researcher obtains and uses information about potential subjects without direct contact with the potential subjects, for the purposes of:
- Developing research questions
- Determining study feasibility (in terms of the available number and eligibility of potential study participants)
- Developing of eligibility (inclusion and exclusion) criteria
- Determining of eligibility for study participation of individual potential subjects
- Identifying potential subjects to contact and obtaining their contact information
M-300.500 Diagram on Prescreening Records (doc)
Advertisements
This information
is to assist investigators
in devising advertisements
to recruit subjects for
research. Advertisements
include posted or distributed
flyers, newspaper or
magazine ads, announcements
placed on the Web or
sent by e-mail, and
information sheets sent
to providers or targeted
groups of prospective
subjects.
The Human Subjects Review
Committees will review
the advertisement and
how it will be used,
to determine that it
is not coercive and doers
not promise unreasonable
benefits. The Committee
will review the final
copy of advertisements
for readability and visual
impact.
Advertisements
should provide the information
that prospective subjects
need to determine their
eligibility and interest.
Include the following
information, worded appropriately,
in advertisements:
"University of
Washington" and
the department/division
name of the investigator
and/or research facility;
the purpose of the research
and/or the condition
under study;
in summary form, the
inclusion/exclusion criteria
that will be used to
determine eligibility
for the study;
a brief list of participation
benefits, if any (e.g.,
a no-cost health examination,
free parking, monetary
compensation);
the time or other commitment
required of the subjects;
and
the person or office
to contact for further
information. When a telephone
number is given, if it
is not dedicated exclusively
to the use of the advertised
study, a contact name
should also be given.
Advertisements should
not promise "free
treatment," when
the intent is only to
say subjects will not
be charged for taking
part. Advertisements
may state that subjects
will be paid, but should
not emphasize the payment
or the amount to be paid.
If payments will vary
(and not be the same
sum to each subject),
the statement about payment
should be of the form, "Subjects
may earn up to $___".
For biomedical studies:
Do not include claims
that the drug, biologic
or device is safe or
effective for the purposes
under investigation,
or that the test article
is known to be equivalent
or superior to any other
drug, biologic or device.
Such representation would
not only be misleading
to subjects but would
also be a violation of
the FDA's regulations
concerning the promotion
of investigational drugs
[21 CFR 312.7(a)] and
of investigational devices
[21 CFR 812.7(d)].
Advertising for recruitment
into investigational
drug, biologic or device
studies should not use
terms such as "new
treatment," "new
medication" or "new
drug" without explaining
that the test article
is investigational.
Investigators are welcome
to address queries
about specific proposed
advertisements to the
appropriate administrator.
Queries related to
existing studies should
be addressed to the administrator
of the Committee that
reviewed the study.
Telephone
If you plan
to approach prospective
subjects by telephone,
you should submit with
your Human Subjects Application
for Committee review
a script or protocol
for the initial call.
This should, in general,
include
- a check to make
sure that the right
person is on the line;
especially important
when announcing the study
name or other information
could breach subjects'
confidentiality or otherwise
put them at risk
- if a message will
be left for subjects
or prospective subjects
who are not available
to take the call, provide
the text of the message,
indicating how breach
of confidentiality
will be avoided when
leaving it (this may
require ensuring that
if some curious person
calls back, they do
not hear a greeting
that itself breaches
the confidentiality
of the subject or
prospective subject)
- an introduction identifying the caller
and the study, and their departmental
and University of Washington affiliation,
- a statement about, or reminder of,
how the prospective subject's name was
obtained
- a question that allows the prospective
subject to opt out of the telephone interview,
or set a more convenient time ("Are
you interested in hearing more about this
study? Is this a good time to talk?")
- a general description of the study
- if any screening questions will be asked,
a description of the questions, especially
of the most personal and sensitive a subject
can expect to be asked, accompanied by
the statement,
"You are free not to answer any
questions you do not wish to answer"
- a request for verbal consent before
proceeding with the questions, and a statement
about what will be done with the screening
data if prospective subjects are screened
out;
- the screening questions that will be
asked, and what will be said to subjects
if they are screened out;
- the arrangement of an appointment or
next step for those eligible prospective
subjects who wish to, continue;
- and a closing that includes a contact
name and telephone number if the person
should have any further questions about
the study.
Recruitment
through Intermediaries
The following information
is provided to investigators
to assist in the use
of intermediaries in
the recruitment of subjects
to participate in research
activities.
When an investigator
has not had prior contact
with subjects, it may
be necessary to enlist
the cooperation of other
professionals and organizations
as intermediaries in
order to avoid an invasion
of potential subjects'
privacy. The role of
the intermediary is to
explain the study in
neutral terms and to
obtain permission from
the prospective subject
to release his or her
name to the investigator.
An intermediary is someone
who has had prior contact
with the subject and
who can provide a linkage
between the subject and
investigator.
The intermediary who is
willing to assist the investigator
in this way should not take
a strong advocacy position
in favor of a particular
research activity (Human
Subjects Manual, Part D,
page 14).
Special care must be taken
if the person doing the
recruiting...is in a relationship
of authority or service
provision with respect
to potential participants.
Such a situation can arise
if a teacher recruits his
or her students, or if
a health practitioner recruits
patients as research subjects.
If possible, it is best
to avoid such situations,
but there can be cases
where this is not possible
(Human
Subjects Manual, Part B,
page 11).
The Human Subjects Review
Committees permit the use
of health practitioners
or other service providers
as intermediaries only
when no alternatives exist
for the recruitment of
subjects. When the use
of these intermediaries
is permitted, the investigator
should take appropriate
safeguards to protect the
welfare of subjects who
may be vulnerable to coercion
or undue influence in such
a situation.
It is the opinion of the
Committees that paying
a per capita recruiting
fee or subject completion
fee to an intermediary
is not in accord with ethical
principles guiding the
use of human subjects in
research. It contradicts
the presumed neutrality
of the intermediary and
may increase the vulnerability
of subjects to coercion
and undue influence. This
practice, therefore, is
not in the best interests
of potential subjects and
should not be permitted.
Screening
Screening is something that can occur at
one or more points in the
process of approach, recruitment
and consent. It can also
occur as a stage of study
activities after consent
has been given and subjects
have enrolled.
From the point of view of human subjects review, screening procedures are
connected not only with the issue of informed consent, but also with the
issue of risk or burden. The following list describes matters typically
addressed in review of screening procedures.
- It is useful to make it possible for subjects to screen themselves
out whenever possible, by being clear about study requirements in
flyers, advertisements, or other preliminary approach and recruitment
material. Doing this means that prospective subjects do not have to
go through (and researchers do not have to conduct) unnecessary
screening interviews.
For example, if one wants only male or only female subjects,
or subjects over or under a certain age, it makes sense to say so in
the recruitment flyer.
- To avoid obtaining sensitive,
identifiable information about people
in the course of screening them out,
it can be useful to "chunk" exclusion
criteria. In this way one can know
that a particular prospective subject
is ineligible for the study, without
knowing specific, potentially sensitive,
things about that person.
For example, if having had any one
of several herpes infections would disqualify
subjects from a study, one could ask, "Have you ever
had one or more of the following illnesses?" A "yes" answer
would be enough to screen the prospective
subject out, without having to collect
any more specific information. When
using such a procedure, it can be useful
to explain it beforehand, when describing
the kinds of questions one is proposing
to ask.
- All things being equal, it
is better not to give prospective subjects
who have been screened out the impression
that they have been screened out because
of some defect on their part, but rather
to put the burden on the study (by
saying, e.g., "whether the
study is a good fit for you"). Another benefit of avoiding talk of
"eligibility" is that one also avoids
encouraging prospective subjects to stretch
a point to try to qualify for interesting
or desirable studies or study conditions.
Recruitment and screening materials should indicate that exclusion
from the study is a matter of study design and not of a defect, or a
failure to perform, on the part of the prospective subject.
- If prospective subjects will be screened before giving consent to be
in the study, they should know what they are being asked to do,
and be given a chance to decide whether or not to do it. This
would includes the following elements.
- a statement that, before it is possible to tell whether the
study is right for the prospective subject, it is necessary to
ask some questions;
- a description or examples of the range, as well as of the
most personal and sensitive kinds, of questions a
prospective subject can expect to be asked, followed
by a statement that they are free not to answer any
questions they do not wish to answer;
- a statement about how long data obtained in screening will be
retained in identifiable form, for those who do not go on
to participate in the study, and
- a request for permission to proceed with the screening
- If it is possible that some subjects
will be screened out after they have signed
the consent form, the Procedures section
of the consent form should describe the
screening procedures clearly, to let subjects
know the point by which they can be sure
whether or not they have been accepted
into the study. The consent form should
also state how long screening data from
those who do not go on to the rest of the study will be retained in
identifiable form.
- If screening involves access to confidential
information (such as educational records,
or protected health information prior
to obtaining consent, the application
should explain (and document) how access
to this information is to be obtained.
For example, to use protected health
information, a Confidentiality
Agreement and
waiver of authorization may be necessary
(available under Forms).
Web-based
Approach and Recruitment
Approach to prospective
subjects, and recruitment
of subjects, are governed
by the same considerations,
no matter what the medium.
Approach and recruitment
are early phases of the
informed consent process.
As a result, all approach
and recruitment materials
and procedures must receive
the appropriate level of
human subjects review or
approval.
To be approvable, a web
site intended to be used
in approaching prospective
subjects, or recruiting
subjects, must meet all
relevant requirements.
In addition to the specific
features laid out in the
University of Washington
Human Subjects Manual,
the material must be written
in clear, direct lay terms,
at a level likely to be
readily understood by prospective
subjects, and must be clearly
presented as approach and
recruitment material. To
refer prospective subjects
to a highly technical,
academically oriented web
site is like mailing prospective
subjects reprints of professional
publications. Except in
specific (and unusual)
cases, it is unlikely to
be an effective form of
communication.
In other words, if you
wish to use web-based recruitment
material, or provide web-based
information for prospective
subjects, you should publish
it on a separate, study-specific
site (rather than merged
with an academic site).
The material on the site
must fit all the usual
requirements for approach
and recruitment material.
Such sites may not be published
until they have received
appropriate Human Subjects
review and approval.
Finally, invitations to
subjects, or prospective
subjects, to contact the
study by e-mail should
contain proper notification
of the confidentiality
issues associated with
e-mail communication.
Use of materials or procedures
that have not received
the appropriate level of
review and approval is
either a protocol violation
(when done in connection
with an otherwise approved
application) or non-compliance
with University of Washington
human subjects requirements
(when done without any
approved application). |
