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Writing an IRB Protocol

Writing an IRB Protocol. Presented by: Shannon Potter, MLIS, CIM and Jan Zolkower, MSHL, CIP, CCRP April 10, 2009. Financial Disclosure. Neither speaker has a financial interest or relationship. Agenda . Part I: Literature Search. Literature Searches: the when, why and how of it

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Writing an IRB Protocol

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  1. Writing an IRB Protocol Presented by: Shannon Potter, MLIS, CIM and Jan Zolkower, MSHL, CIP, CCRP April 10, 2009

  2. Financial Disclosure Neither speaker has a financial interest or relationship.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. Types of Literature Meta- Analysis Systematic Review Randomized Controlled Trial Cohort studies Case Control studies Case Series & Case Reports Animal research & Laboratory studies

  10. 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

  11. Literature Search: Tracking Investigators • Web of Science • Searching of the references cited in paper • Search for citations to key papers to locate similar research

  12. 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

  13. How to Access PubMed

  14. Full Text Access via PubMed

  15. 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.

  16. 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

  17. Example Search Strategies • Complications:("Mesh heading/complications"[MAJR] OR "Mesh heading/adverse Effects"[MAJR]) OR (“Mesh heading”[MeSH] AND ("Postoperative Complications"[MeSH] OR "Intraoperative Complications"[MeSH] OR “Treatment Outcome”[MeSH]))The subheading adverse effects includes the following subheadings: /toxicity and poisoning • Therapy: (“Mesh term” [MeSH] AND “Therapeutics” [MeSH]) OR (“MeSH term/therapy”[MeSH])Consider including additional facets for specifics types of therapy (e.g. drug, diet, surgery subheadings)

  18. 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

  19. 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/librarianprovides 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.

  20. Drug Information Portal http://druginfo.nlm.nih.gov

  21. 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.

  22. 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?rid=citmed.TOC&depth=2 • For additional assistance, contact the EBL’s Information Research Advisory Group (IRAG) at eblprotocolhelp@vanderbilt.edu

  23. Why is this important information?

  24. 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/jul01a.pdf

  25. QUESTIONS?

  26. Contact information for future questions: shannon.potter@vanderbilt.edu (615) 322-2919 jan.zolkower@vanderbilt.edu (615) 343-8395

  27. THANK YOU!!

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