Elements of a Research Project - Hartford HealthCare



Elements of a Research Proposal / ManuscriptThe Research Program has set the following guidelines as standards for protocol submission. These are similar to requirements for manuscript publication by most journals. The proposal must clearly outline the 11 areas/sections below.Area/SectionWhat is required?Why?If I am new to all this, how/where can I get help?1Literature reviewProvide relevant background with appropriate citations that match references Discuss advances, improvements, or discordant findings related to study topic The “inverted triangle” format is helpful, beginning with general statement of problem and narrowing to the specific question or hypothesisGives reader a sense of timeliness and relevance of study in the context of previous literatureDiscussion should logically lead to why current study is needed; why this is the “next step”Read other articles for sense of appropriate scope and format of literature review sectionElectronic searches, such as Ovid, Medline make searching easierMedical library can assist2Purpose/Aims/ScopeExplain the purpose of the studyList specific aimsGives reader an explanation of why the study is being undertaken and what will be investigated3Hypotheses or Research QuestionsFor clinical trials and other explanatory research primary, and other, if applicable, hypotheses need to be clearly statedFor descriptive or exploratory studies, research questions appropriately substitute for hypothesesScientific reviewers will check to ensure that tests being used are appropriate for evaluation(s) being conductedPrepare your hypotheses as question or expectation of what you are trying to show – Mentors or Research Program’s Senior Scientists can help with more scientific formatting4Research Design Explain study design: Retrospective or prospective?Randomized? Placebo/Control group?Repeated measures?Based on this information, IRB will monitor proper conduct of the experiment/research, including human studies issues and consenting issuesThis is foundation on which entire scientific value restsCan replicate and/or extend similar study in lit reviewOnce concepts are clear, talk with Mentors and/or Research Program’s Senior Scientists5Sampling - Enrollment CriteriaList inclusion and exclusion criteria, e.g.: demographic characteristics (age, gender, language, etc.); Why? Are there medical or other contraindications?For retrospective, what time period? Why?IRB needs this information to ensure safety of research subjectsScientific reviewers need this information to ensure that the appropriate population is being included as appropriate to research goals Clinical reasons should be primary guidance to inclusion and exclusion criteriatalk with Mentor(s), Senior Scientists6Methods of Data CollectionProvide study timeline and procedures Describe method of data collection (e.g., chart review, patient interview, etc.)Describe variables and outcomes to be collected and how each will be measuredRationale and contents for any new measuresSample size determination – power calculation (often part of statistics section)Allows reviewers to check that time frames, data (variables), and personnel are appropriateAllows IRB to check that safeguards for PHI are in placeValidated measures always preferredReviewers will discuss validity/reliability of measuresScientific reviewers will check to ensure that there is an appropriate number of participants – sufficient to obtain a definitive answer or support conclusions but not more than neededReview similar studies for how measurements taken – replicate or improveWith IRB approval, preview charts or administrative database for availability of clinical infoWeb sites and books exist for validated measuresSample size -- web sites can help, or talk with Senior Scientists, who have specialized software and can do this for you7Use of BiospecimensDescribe any biospecimen tissue collection proceduresWill the study involve the use of previously banked tissue? If so, identify source Allows IRB to ensure specimen collection is in compliance with regulations Discussion with Research Councils or IRB/HRPP8Data Storage, Use and SecurityWhere will data be stored, for how long, who will have access to it, what will be done to protect PHI (if applicable)?Maintaining confidentiality is tantamount to performing proper researchHRPP and/or your assigned senior scientist9Data analyses and statistics Describe statistical test(s) to be used, explain how these will be applied to the dataInclude alpha level and other parameters (e.g., sidedness, ITT, PP)Provide sample size needed based on power analysis (if not done above)Provide info on software to be usedAllows reviewers to determine whether appropriate statistical processes/tests are used for design of studyRelates sample size and statistics to be usedReviewers can determine if validated software will be used rather than questionable algorithmsSimilar studies in literatureDiscussion with Mentors or Senior ScientistsAvoid boilerplate language from other protocols10Benefit/Significance to HH and its patients Explain significance of study to the hospital mission and its patientsDescribe clinical benefit / utility Assures the Research Program that HHC’s mission is supported and that through treatment and/or knowledge, patient care is improvedYour Mentor and colleagues11ReferencesUnless absolutely new area – there should be sufficient literature to include a minimum of 3 prior studiesAny standard format (AMA, APA) is acceptable but please be consistentAssures the Research Program that the time spent and effort undertaken will add to knowledge base; will be required for eventual manuscript submissionAMA guidelines are posted on the Web.Journals often include guidance in Authors’ InstructionsOther things to consider:(a) Page numbers (usually inserted in the document footer) are required.(b) Headers should include PI last name, HHC-20yy-0xxx number (if known), and the revision date, which should be changed each time the protocol is revised/amended after initial IRB approval. (c) Abbreviations and acronyms should be written out/defined upon first use, with the abbreviation/acronym as a parenthetical. If the protocol contains many of these, consider including a glossary ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download