August 2024 SOCRA Source Journal - Journal - Page 30
other logistical considerations.
TABLE 4
Key Elements of the
Protocol
•
•
•
•
•
•
Background
Methods and
procedures
Risks and safety
Bene昀椀ts
Consent
Data acquisition
and analysis
Table 4 highlights key elements
of the protocol. While the
Background section does not
need to be long, it does need
to be robust. Background
information must explain
why the research will be
conducted and how the study
will contribute to generalizable
knowledge.
Methods and procedures must
be covered in the protocol.
This is especially important for
studies that are regulated by the
FDA. Methods must be explicit
but not so speci昀椀c that they
make following the protocol
dif昀椀cult. For example, if you
intend to recruit participants
for prospective enrollment, do
not limit your search to just
seeking out participants in a
clinic setting. Consider also
reviewing charts and sending
out recruitment letters.
Procedures must also be
explicitly described in the
protocol. Often, procedures
only cover what the investigator
does. It is important to discuss
the procedures section with a
clinical research coordinator or
a nurse to determine if there are
30
The Risks and Bene昀椀ts and
Safety section must de昀椀ne
these precisely and include
the reporting process. The
reporting process includes the
timeline of reporting, who will
handle reporting, and to whom
to report. Depending on the
trial, severity or seriousness also
may need to be de昀椀ned.
In pediatric research, who needs
to provide informed consent
must be clari昀椀ed. If the study
is minimal risk, generally only
one parent needs to provide
informed consent. Two parents
may be necessary for a greater
than minimal risk study.
Information on the informed
consent process must include
who is being consented,
how this will be done, and
the intervals for consenting.
Regardless of the age of the
participant, the informed
consent section must describe
the process, including whether
consent will be done in person
or remotely and whether the
study will use e-consent, paper
consent in person, or e-consent
in person.
Once the child has reached the
age of assent, assent from the
child is necessary in addition
to informed consent from the
parent(s) or guardian(s). The age
of assent is determined by the
Institutional Review Board at an
institution. It should be noted
that the regulations do not
specify an age, so this varies by
institution.
Each institution also determines
its assent procedure. Some
institutions only require the
parents attest to their child’s
SOCRA SOURCE © May 2024
assent. Other institutions
require the child to sign an IRBapproved assent document.
It may be warranted to assent
children separately from their
parents to reduce the risk of
parental in昀氀uence on the child’s
willingness to participate.
A statistician should write the
Data Acquisition and Analysis
section of the protocol. If a
statistician is not available at
the clinical research site and the
investigator does not have the
expertise to write this section,
it should be contracted out to
a statistician. A power analysis
to determine sample size is
necessary for certain studies
such as hypothesis-driven
research. However, pilot studies
or Phase I studies do not require
a power analysis as the aim is to
determine feasibility or safety,
respectively.
The Research Electronic Capture
Consortium, or REDCap, enables
direct data entry from source
documents such as parent
interviews, electronic medical
records, and electronic case
report forms to an electronic
repository. It is free for academic
medical centers and non-pro昀椀t
organizations. This is important
for IIR studies since these studies
are typically either unfunded or
federally funded where there
is little money to pay for an
electronic data capture system.
REDCap is relatively intuitive as
well. Customizing REDCap for
the clinical research site is easy
and the platform offers many
tutorials. It is necessary, however,
to have some information
technology support at the
clinical research site for REDCap
maintenance.