Writing an IRB Protocol

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Writing an IRB Protocol

• Presented by
• Shannon Potter, MLIS, CIM and
• Jan Zolkower, MSHL, CIP, CCRP
• April 10, 2009

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Financial Disclosure

• Neither speaker has a financial interest
• or relationship.

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Agenda
Part I Literature Search

• Literature Searches the when, why and how of it
• Why is it important to conduct a literature
  search for a study protocol
• How to construct an effect literature search
• Consulting resources Databases and Information
  Sources
• How to access them and use them effectively

Part II Writing the Protocol

• Why is a protocol necessary
• What components need to be included in the
  protocol
• Examples of protocol sections

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When is a literature search useful?

• Provide background information on a study
  protocol
• Cite the incidence or prevalence of a condition
  or a disease
• Summarize the information or lack of information
  to support the purpose and relevance of the
  research question
• Provide existing data to support the number of
  participants needed to demonstrate a difference
  in a comparative study
• Identify the distribution, frequency and types of
  possible adverse events or effects

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Why do a literature search? (i.e. why not just
grab the papers lying around or do a
search?)

• Avoid missing important information
• Evidence-based medicine implies the need to base
  clinical decisions on the results of prior
  scientific study
• Find out that work you are planning has already
  been done
• Stay abreast of new research and stimulate the
  discovery of novel investigations
• Google The secrets of a former librarian
  revealed

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Sources of Information

• Digital Library vs. databases
• Digital Library is a portal to electronic
  resources (books, journals, databases)
• Databases contain article citations (e.g. PubMed,
  Web of Science)
• Getting started background information
• UpToDate is a database of synthesized clinical
  evidence and practice expertise. Content is based
  on journal literature to offer current practice
  recommendations supported by high-quality
  evidence.
• MDConsult is a virtual medical library that
  includes the full-text of well-known journals and
  textbooks, clinical guidelines, drug information,
  and patient education handouts in English and
  Spanish.

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Effectively search the literature

• Abundance of information can make it difficult to
  find useful information
• Searching can be time consuming and frustrating
• Missing information can lead to major problems in
  the approval the protocol or even compromise the
  safety of participants
• Poorly constructed protocol lacking the
  scientific background information may not yield
  useful or replicable results

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Prepare to ask a useful question and generate an
effective query

• Identify the context and key concepts
• Establish limits such as date of publication or
  specific journal titles
• Decide whether the search must be exhaustive or
  specific
• Select appropriate databases and resources
• List the all the terms and keywords

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Types of Literature

• Meta-
• Analysis
• Systematic
• Review
• Randomized
• Controlled Trial
• Cohort studies
• Case Control studies
• Case Series Case Reports
• Animal research Laboratory studies

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Literature Search Locating Primary Data

• PubMed (Medline)
• Key resource for biomedical literature
• Multiple searching functions
• Search using subject headings (MeSH)
• Combine searches use keyword searching
• (vitamin C OR vitamin e) AND myocardial
  infarction
• Print articles
• Check abstract link and Digital Library

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Literature Search Tracking Investigators

• Web of Science
• Searching of the references cited in paper
• Search for citations to key papers to locate
  similar research

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PubMed

• Strengths
• Provides access to the biomedical journal
  literature, including over 18 million citations
  from the mid-1960's to the present
• Controlled vocabulary (MeSH) helps to focus your
  search
• Provides links to full-text electronic articles
• Updated daily
• "Related Articles" feature uses a word-weighted
  algorithm to link from a particular citation to
  additional relevant material
• Weaknesses
• Can be time-consuming to search because of its
  size
• Quick searches may omit relevant citations, with
  the danger that you may miss important viewpoints
  in the literature
• Controlled vocabulary terms (MeSH) are updated
  annually, so may not accommodate new concepts
  well
• Includes literature from over 70 countries, but
  has a North American bias and may omit relevant
  European literature

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How to Access PubMed
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Full Text Access via PubMed
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Accessing Full Text Articles

• What is the difference between PubMed and PubMed
  Central (PMC)?
• PubMed is a database that contains over 18
  million
• citations and abstracts of articles from life
  science,
• medicine, veterinary medicine, and biotechnology
  journals.
• It includes some links to full text articles in
  PubMed Central
• and other locations.
• PubMed Central (PMC) is the U.S. National
  Institutes of Health (NIH)
• free digital archive of biomedical and life
  sciences journal literature.
• It includes more than 1 million full-text
  articles archive that are
• provided for free to the public. Most articles
  have a corresponding
• citation in PubMed. PMC contains additional
  material, such as book
• reviews, that are considered out of scope for
  PubMed.

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PubMed Features

• My NCBIsave searches, save collections, receives
  email alerts
• Single Citation Matcherconveniently find and
  access an article
• Limitslimit the set of results by language, date
  or journal subsets
• Extensive help and user documentationincludes
  tutorials and handouts

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Example Search Strategies

• Complications("Mesh heading/complications"MAJR
  OR "Mesh heading/adverse Effects"MAJR) OR
  (Mesh headingMeSH AND ("Postoperative
  Complications"MeSH OR "Intraoperative
  Complications"MeSH OR Treatment
  OutcomeMeSH))The subheading adverse effects
  includes the following subheadings /toxicity and
  poisoning
• Therapy (Mesh term MeSH AND Therapeutics
  MeSH) OR (MeSH term/therapyMeSH)Consider
  including additional facets for specifics types
  of therapy (e.g. drug, diet, surgery subheadings)

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Example Literature Requests

• Relative rate of infection for subcutaneous
  access ports, tunneled catheters, Hickman
  catheters and PICC lines for long-term venous
  access
• Pharmacokinetics of intravenous lidocaine in
  normal and pregnant subjects
• Databases PubMed, MICROMEDEX

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Searching for Drug Information

• NLM/NIH Drug Resource http//druginfo.nlm.nih.gov/
  Access drug information from the National
  Library of Medicine and other government
  agencies search by trade or generic name.
  Includes a link to resources for researchers.
• Micromedex http//www.thomsonhc.com/hcs/librarian
  provides searchable databases for drug
  information toxicology, drug interaction,
  contraindications, clinical effects, dosing, and
  other details.
• FDA MedWatch http//www.fda.gov/medwatch/
  provides timely safety information on
  prescription and OTC medications, as well as
  nutritional products and medical devices.

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Drug Information Portal http//druginfo.nlm.nih.g
ov
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Vanderbilt University PubMed Policy Certification

The NIH Public Access Policy, effective April 7,
2008, mandates that peer reviewed journal
articles arising in whole or part from NIH funded
research be deposited within 12 months of
publication in the freely accessible PubMed
Central (PMC) repository.
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Literature Search Additional Resources

• Other useful resources
• Pharmacology/drug studies EMBASE (European
  literature)
• Biosciences-related or animal studies BIOSIS,
  Web of Science
• Behavioral/psychology PsycInfo, Social Sciences
  Index
• Nursing CINAHL
• Authoritative volume on citing print and
  electronic medical information NLM "Citing
  Medicine" at the NCBI Bookshelf
  http//www.ncbi.nlm.nih.gov/books/bv.fcgi?ridcitm
  ed.TOCdepth2
• For additional assistance, contact the EBLs
  Information Research Advisory Group (IRAG) at
  eblprotocolhelp_at_vanderbilt.edu

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• Why is this
• important
• information?

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OHRP Determination Letter

• Ellen Roche, a healthy volunteer, died as a
  result of her participation in a research study
  at John Hopkins.
• OHRP noted the investigators and the IRB failed
  to obtain published literature about the known
  association between hexamethonium and lung
  toxicity.
• OHRP Determination Letter to John Hopkins is
  located at http//www.hhs.gov/ohrp/detrm_letrs/ju
  l01a.pdf

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QUESTIONS?
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• Contact information for future questions
• shannon.potter_at_vanderbilt.edu
• [phone]
• jan.zolkower_at_vanderbilt.edu
• [phone]

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THANK YOU!!