Protocol Guidance

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. 

 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:

• Scientific Review Requirement