Streamlining protocol review with checklists
Lists can help focus on the small details
Four years ago, the research program at Connecticut Children’s Medical Center in Hartford looked at its process for proposal review of pediatric studies and decided to strengthen and streamline the process.
"The idea was to have a more standardized approach to review, especially with things that are repeated over and over again [in the process]," says Francis DiMario, MD, CIP, associate chair of academic affairs, Department of Pediatrics, medical director, Human Research Protection Program, and Division Head Emeritus, Pediatric Neurology, at CCMC. "We wanted to make sure reviewers did not overlook the simple things."
To accomplish this, the Connecticut Children’s IRB devised checklists to assist reviewers in completing the process. The New Protocol Reviewer Checklist was first developed four years ago, and the lists have been revised over time as needed. The IRB also has checklists for new submissions, full board reviews, submissions for expedited processes, amendments, continuations, and new proposals.
IRB members use the New Protocol Reviewer Checklist for new submissions, expedited submissions, and for full board reviews. It was developed by DiMario and the HRPP staff. "Quite a few people were involved and we shared our experiences using checklists," DiMario says. "I didn’t think I’d be a big fan of it, and I think most people felt the same way — Oh no, more things to fill out.’ I think it does help to improve efficiency and makes sure each review is done the same way. Everybody gets the same look."
DiMario says the review checklists have improved the depth and quality of protocol review. "I think the most important use of checklists was to assist people in a logical and thorough review process," he says. "Members felt that the checklists should be updated periodically and revised, that they have an educational value in and of themselves as well as guide the review process." As a result, the lists are revised as needed to make them more streamlined and user-friendly, DiMario says.
Sample questions
The New Protocol Reviewer Checklist is about seven pages long and includes sections on inclusion/exclusion criteria, scientific design, informed consent, risks and benefits, resources, privacy and confidentiality requirements, compensation, and other considerations. The end of each section includes space for reviewers to leave questions or comments for the principal investigator. There are also attachments for waivers or modification of informed consent.
Here are some sample questions from the New Protocol Reviewer Checklist:
Specific aims, background, and significance
Are the study aims/objectives clearly specified?
Are there adequate preliminary data to justify research?
Is there appropriate justification for this research protocol?
Inclusion/Exclusion Criteria:
Are the inclusion/exclusion criteria clearly stated and reasonable?
Is the selection of subjects appropriate and equitable?
Are minorities, women, children, or other vulnerable populations included in the study design?
Is the inclusion or exclusion of minorities, women, children, or other vulnerable populations justified?
For subjects vulnerable to coercion or undue influence, are additional safeguards included to protect the rights and welfare of these subjects? E.g., prisoners, mentally ill, economically/educationally disadvantaged, employees.
Subject recruitment & enrollment
Are recruitment methods for all groups well defined?
Are the location, setting, and timing of recruitment acceptable?
Are all recruitment materials submitted, if applicable? If YES, is the text and formatting deemed non-coercive and easily understandable?
Are there acceptable procedures for screening subjects prior to recruitment? Mailings, record reviews.
Scientific design
Is the scientific design adequate to answer the study’s question(s)?
Is the scientific design (e.g. randomization, placebo-control) adequately described and justified?
Are the study aims/objectives likely to be achievable within the given time period?
Research Procedures
Are the rationale and details of research procedures adequately described and acceptable?
Is there a clear differentiation between research procedures and standard of care and evaluation?
Are there adequate plans to inform subjects of specific research results?
If no, is this acceptable?
Data analysis
Is the rationale for the proposed number of subjects reasonable? NOTE: all studies, except pilot studies, require a formal sample size.
Are the plans for data and statistical analysis defined and justified? (stopping rules, endpoints)
Are there adequate provisions for monitoring data? (Data Safety Monitoring Plan) NOTE: required for all biomedical/behavioral intervention trials and GCRC research.
