Version Date: July 24, 2008
Elements of a Protocol guidance
The
Health Sciences IRBs now require the submission of a formal protocol for
research studies submitted using an Application for Initial Review for Research
Involving Human Subjects. Formal
protocols are being required in order to facilitate scientific review of the
research study. For some studies, the
protocol may be brief. Below is guidance
regarding the elements that should be included in protocols for most research
studies. These guidelines are based on
the National Institutes of Health and National Science Foundation grant
applications. For further assistance in drafting a protocol, please see ICTR's Protocol Templates.
Protocols
are not required for Applications for Initial Review for Research Involving Human
Subjects that are limited to seeking approval for the purposes of a grant
(e.g., core or training). In the case
where the UW is serving as a reading center, a data analysis center, or sample
analysis center, the protocol for the study for which UW is acting in a
supportive role should be provided. If a
formal protocol already has been developed for a research study, please ensure
that the elements identified below are addressed.
- Title
Page: Serves to provide identifying information about the project
- Title
- PI
Name and Institutional Affiliation
- Protocol
Version Date
- Coordinating
Center Identification (if applicable)
- Co-Investigators
(if applicable)
- Study
Coordinator (if applicable)
- Funding
Sponsor (if applicable)
- Project
Summary: Orients the reviewer to the project
- Similar
to NIH and NSF guidance, provide a summary of the proposed activity that should
be informative to other persons working in the same or related fields and
insofar as possible understandable to a scientifically or technically literate lay
reader
- Background
and Significance: Helps to establish the intellectual merit of and rationale
for the project
- Describe
the proposed research in the context of existing knowledge and available
literature and specifically identify the gaps that the research is intended to
fill either in terms of scientific knowledge or clinical practice
- Provide
an account of the preliminary studies pertinent to this application or note if
such studies have not been conducted
- For
research involving the testing of drugs, biologics, or devices:
- Identify
any investigational agents, drugs, devices, or biologics that will be
administered or implanted into subjects
- Summarize
relevant preclinical data
- Summarize
relevant clinical data to date
- Provide
a rationale for the dosing or use of the device, risks to subjects, and
potential benefits to subjects
- Specific
Aims/Study Objectives: Helps clarify the questions the researcher expects to
answer
- Identify
hypotheses being tested/primary endpoints/primary purpose of the protocol
- Describe
secondary endpoints (if applicable)
- Substudy
endpoints (if applicable)
- Study
duration
- Research
Design and Methods: Provides specifics as to how the research will be conducted
and the means used to achieve the project’s specific aims/study objectives
- Describe
the study population, including number, age range, health status
- Inclusion
Criteria
- Exclusion
Criteria
- Subject
identification and recruitment
- List
any collaborating sites where human subjects research will be performed, and
describe the role of those sites and collaborating investigators in performing
the proposed research (if applicable)
- Identify information
extracted from medical records
- Identify any specimen/data collection, handling, storage
- Include a description of the source of the data/biospecimens;
the role(s) of providers of the data/biospecimens in the proposed research; and
the manner by which the privacy of research participants and confidentiality of
data will be ensured
- Provide information about confidentiality protections,
sharing of data, and disposition of data
- Identify any substudies
- Indicate what study activities happen when, including,
when applicable, a study schedule that notes number and length of study visits
for subjects, such as any of the following
- Screening for eligibility
- Enrollment/baseline
- Treatment/intervention period
- Follow-up
- Final study visit
- Early termination visit
- Unscheduled visits
- For research involving the testing of drugs/biologics
describe:
- Drug formulation, packaging, labeling and source
- Drug storage and stability
- Preparation, dosage, and administration of drug(s)
- Drug accountability procedures (if applicable; usually
not required for drugs obtained through commercial venues and charged as
standard of care)
- Concomitant medications allowed/disallowed, washout periods
required
- Use of placebo and source of placebo
- Precautionary, prohibited medications and procedures
- Prophylactic medications and procedures
- Rescue medications
- Clinical or laboratory evaluations required
- For research involving testing of devices describe:
- Device specifications, packaging, labeling
- Device storage
- Device implantation/application
- Device accountability procedures
- Concomitant medications allowed/disallowed, washout
periods required
- Use of sham procedures
- Precautionary, prohibited medications and procedures
- Prophylactic medications and procedures
- Device removal
- Clinical or laboratory evaluations required
- Data and Safety Monitoring Plan: Addresses how
problems/side effects will be identified and handled
- For
studies that are minimal risk, describe how potential problems will be
monitored and handled (e.g., breaches of confidentiality, emotional upset)
- For
clinical studies or research involving more than minimal risk to subjects, describe:
- Who
will monitor adverse events (AEs) and unanticipated problems (UPs) involving
risks to subjects or others and when events will be assessed
- How
AEs or UPs will be recorded and communicated amongst research team members and
who is responsible for making the reports
- The
composition and how frequently the Data and Safety Monitoring Board (DSMB)
exists, if one has been formed for the study
- Identify
how often AEs and UPs will be monitored and what events will be reported to the
sponsor and/or the IRB
- Describe
stopping rules for the study
- Describe
what occurs if a subject withdraws prematurely
- Statistical
Considerations: Provides an explanation as to why the number of subjects was
chosen and the means for analyzing data will meet the specific aims/study
objectives
- Describe
analyses that will be performed or why no statistical analysis will be
performed
- Describe
sample size considerations, which may include a formal justification for sample
size calculations
- Describe
planned interim analyses
- Describe
safety reviews
- Describe
final analysis plan
- Data
and Record Keeping: Addresses how data will be captured, protected, and shared
with others
- Describe
who will manage the study data
- Describe
how data confidentiality will be assured and when data will be destroyed or
anonymized
- Describe
data collection methods
- Describe
how long study records will be kept
- Bibliography
& References Cited: Allows the reviewers to better understand the context
of the study in light of other research available
See Also: