6. Selection & Recruitment of Subjects
Selection of
Subjects
Distributive justice, the third principle of The Belmont
Report (See Chapter 1,
"Introduction: The Foundation of 45 CFR 46: The Belmont
Report") requires the fair selection of subjects and
the equitable distribution of the risks and benefits of research.
The systematic selection of subjects because of easy
availability, their compromised position, or because of social, racial,
sexual,
economic or cultural biases institutionalized in society results
in an uneven distribution of the benefits and the burdens of
research. The HSPC will closely examine research that requests
the recruitment of subjects solely due to their easy
availability, compromised position, or susceptibility to
manipulation. For example, students, patients, or laboratory
employees are compromised to the extent that their grades, access
to health care, or jobs are dependent on those investigators
recruiting them for research. The protocol should clearly
articulate how the recruitment will avoid the appearance of
coercion when selecting subjects who are in a dependent
relationship to the investigator. (Please see Chapter 8, "Special Classes of
Research Subjects: Students and Employees," for more
information.)
In order to allow for the fair and equitable distribution of
the burden of research and to ensure that certain populations,
such as prisoners or patients in mental institutions, were not
recruited solely because of their easy availability, the National
Commission for the Protection of Human Subjects recommended a
hierarchy of preference in the selection of subjects for
research: adults before children; competent individuals before
incompetent individuals; and non-institutionalized persons before
institutionalized persons. To adequately assess the risks and
benefits of participation in research, the HSPC requires accurate
information regarding the number of subjects to be recruited and
tested. In addition, the HSPC will closely examine the
characteristics of the subject population, such as age, gender,
and population diversity outlined in the protocol and the
procedures for identifying and recruiting subjects.
The mandate for the equitable distribution of the risks and
benefits of participation in research to include women and
minorities was addressed by the NIH, in the Outreach
Notebook for the NIH Guidelines on Inclusion of Women and
Minorities as Subjects in Clinical Research, published
in 1994 (Please see Appendix
8, for more information). The guidelines indicate that
researchers should include minorities and women in study
populations, "so that the research findings can be of
benefit to all persons at risk of the disease, disorder, or
condition under study." The HSPC will ask for a clear and
compelling justification if women and/or minorities are not
appropriately represented or are excluded from the research.
(Please see Chapter 8, "Special
Classes of Research Subjects: Women; Minorities,"
for more information.)
In order to ensure that the burdens of research are evenly
distributed, the HSPC is required to consider more than the risks
associated with the research procedures. The HSPC will also
consider the impact participation in research poses on the daily
life of the potential subject. For example, the Committee will
consider reimbursement of subjects for inconvenience posed by the
research, such as: the time required to participate; travel
involved and/or parking costs; restrictions on diet or other
activities; etc. Investigators should include provisions in the
protocol for addressing these concerns, especially for research
that poses little or no direct benefit for the subjects.
Recruitment
of Subjects
Recruitment is the dialogue that takes place between an
investigator and a potential subject prior to the initiation of
the consent process. In some ways, recruitment is the
introduction to the consent process. Recruitment may take the
form of a flyer, a newspaper advertisement etc., or a verbal
exchange between an investigator and a potential subject.
Investigators that are responsible for both the primary care of a
patient/client and wish to consider enrolling the patient/client
into a research project should carefully differentiate for the
patient/client the alternatives and options of participation in
the research without undue prejudice or pressure.
Respect for potential subjects begins with recruitment
procedures that ensure the voluntary participation of the
subject. Potential subjects should not feel coerced into
participating in research, nor must they fear the loss of some
benefit to which they are otherwise entitled if they choose not
to participate. A person in authority, such as a teacher
recruiting students or a physician recruiting patients, should
take special precautions to ensure that a potential
subject’s decision to participate in research is not based
on subtle pressures such as grades or a fear of loss of benefits,
like medical treatment.
Investigators proposing to recruit their students or patients
as research subjects should justify in the protocol the necessity
for the inclusion of the dependent subject. In addition, the HSPC
will closely scrutinize the precautions in place to prevent the
appearance of coercion in the recruitment of the subjects.
Investigators build a strong foundation for ethical research
by ensuring and preserving the privacy and confidentiality of
potential research subjects. In order to avoid a breach of the
potential subject’s privacy, investigators should not ask
institutions, or their employees such as physicians or case
workers to directly identify potential subjects for a research
study. Instead, an investigator should ask the physician, case
worker, etc., to first approach potential subjects (or their
parent/guardian, as appropriate) and inform them of the research.
A potential subject’s privacy and confidentiality may be
compromised simply by being identified as a potential participant
in a study (for example, of cancer, AIDS, schizophrenia, or
sexual deviance) or by identifying a patient/client’s
disorder to an investigator for the purposes of recruitment into
research without the patient’s consent.
An investigator should not ask institutions or individuals to
release records or anecdotal information either for the purposes
of identifying potential subjects or for examination by the
investigator, unless the information is in the public domain. For
example:
Ms. Smith is diagnosed with emphysema by Dr. Jones. Dr.
Jones has not yet informed Ms. Smith about her disease. Dr.
Brown is conducting research on emphysema. Dr. Brown asks Dr.
Jones for the names and telephone numbers of all patients
with emphysema. Dr. Brown contacts Ms. Smith to recruit her
for his emphysema study. Ms Smith is shocked not only that
Dr. Brown has her name and personal medical information but
that she has learned of her emphysema from someone she does
not know. Dr. Jones has breached Ms. Smith’s
confidentiality by giving her name without permission to Dr.
Brown. Dr. Brown has breached Ms. Smith’s privacy by
contacting Ms. Smith without her permission.
Oftentimes, in order to protect the privacy of the potential
subject and decrease any appearance of coercion, the Committee
will request the use of a flyer or a contact letter posted in the
waiting room or the lobby of the facility to inform potential
subjects about the research. The flyers or post-cards, etc.,
would include a description of the study and a telephone number
for potential subjects to call if they are interested. Through
this process, investigators avoid the appearance of coercion in
the initial recruitment stage, while potential subjects maintain
their privacy by initiating contact with the investigator.
Recruitment
tools:
A recruitment tool informs potential subjects of a research
activity and provides them with an opportunity to contact the
researcher. A recruitment tool may include but is not limited to
post-cards, flyers, advertisements, press releases, brochures,
and postings on the internet. Investigators are encouraged to use
the following guidelines when developing recruitment tools:
- Information should not be misleading to subjects,
especially when a study involves vulnerable populations;
- Include the name, affiliation, and address of the
investigator;
- the purpose of the research;
- the eligibility criteria for participation;
- an honest and direct description of the risks and
benefits of the study;
- whom to contact for further information;
- no claim should be made as to the superiority, safety, or
effectiveness of drugs or devices used in research.
| NOTE: All recruitment materials are required
to have HSPC review and approval prior to implementation. |
| NOTE: When recruiting subjects from another
institution, investigators are required to gain approval
from that institution’s, Institutional Review Board
(IRB). If the institution does not have an IRB,
investigators are required to obtain a letter of
compliance on the facility’s letterhead with a
statement that the agency/institution will, "review,
abide by, and comply with the procedures approved by the
UCLA HSPC." |
Payment for
Participation in Research
The nature, amount and method of payment or other remuneration
should not constitute undue inducement to participate (i.e.,
the payment alone should not serve as sufficient inducement for
the subject to volunteer). Investigators should consider
reimbursement for the inconvenience posed to subjects or other
costs to subjects resulting from participation in the research,
such as: parking fees, travel, lost time from work, baby-sitters,
etc.
Since subjects reserve the right to withdraw their
participation from the research without prejudice, payment to
subjects should be prorated, i.e., partial participation in a
research activity would obligate partial payment. The HSPC will
review both the amount of the payment and the proposed method of
disbursement to ensure that neither includes problems of coercion
or undue influence.
Recruitment
of Children
The ethical requirement of respect for persons, as outlined in
The
Belmont Report, applies to children as well as adults.
Children, however, are in a dependent relationship to adults and
easily manipulated in an academic or clinical setting. A
child’s dependent relationship entitles them to extra
protections and are thus considered a "vulnerable subject
population" (Please see Chapter 8,
"Special Classes of Subject Populations: Children"
for more information) Investigators should take every precaution
to insure that a child’s decision to participate in research
is both voluntary and free from coercion. A child’s refusal
to participate should not be met with a negative response or
punishment.
The HSPC strongly recommends that investigators address the
following when submitting applications that include the
recruitment of children:
- investigators should acknowledge and create a mechanism
for addressing and minimizing the coercion implicit in
requests to participate from parents, teachers, or other
adult authorities, such as the investigator or the
research staff;
- investigators should make provisions to minimize the fear
of ridicule, social pressure, or peer pressure to
participate;
- incentives or rewards for participation may be used but
should not be so valuable, within the value system of the
child, as to sway their legitimate reluctance to
participate.
Permission
of the School:
School officials and/or teachers do not have the authority to
give consent for the participation of children in research. Only
a parent or guardian may allow a child, with the child’s
assent, to participate in research. The HSPC requires submission
of proof of approval of the school district prior to allowing
investigators to contact, recruit, or enroll children into a
study. Investigators should contact school district officials
regarding the appropriate procedures for obtaining permission to
conduct research in individual schools.
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October 29, 2004
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