1. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC CHAPTER 8 Steps to Implementation

2. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Steps to Implementation Important first step in research Helps minimize problems during study Detailed planning starts before study begins 2

3. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Writing Study Protocol Helps clarify goals and method of investigation Need plan before IRB approval is granted Provides an operational guide for the entire research team Creating a general plan-consider the following - What is the primary goal of the study? - What makes this particular study important? -What has previous research shown in this area? - How is the study to be carried out? 3

4. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Creating a General Plan Addresses List the study’s specific aims- include a statement of what goals are to be accomplished and the hypothesis to be tested. State clearly the primary significance of the study-show how your study will fill in knowledge gaps. Cite any preliminary studies you may have undertaken. show that preliminary experiments have demonstrated the feasibility of methods you intend to use for the current study. Specifically state the experimental design- lay out procedures, advantages and disadvantages of methods used, limitations of the methods or study design 4

5. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC IRB Study Protocol Outline Human subjects require protocol Some key items in protocol: -Name of investigator/co-investigator(s)-leaders of research project -Title of project -all projects must have a title without abbreviations. -Introduction. describe the significance of the study -Purpose, specific aims, and hypotheses- state clearly what you hope to learn from the research. -Study design- provide information that will allow the IRB to confirm the claim that methods employed will enable the investigator to evaluate the hypothesis posed and to collect valid data. 5

6. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC IRB Study Protocol Specific Procedures-explain all procedures in detail and uncommon medical procedures Population: indicate the source and means of identifying patients/subjects and control subjects as well as the number of subjects to be studied. Unconscious Patients-may not be used in research studies unless there is no alternative method of approved or generally accepted therapy that provides an equal or greater benefit: -The study offers potential benefit to the patient. -The patient’s condition is life threatening. -There is inability to communicate with the patient. -There is insufficient time to obtain consent from a legal representative or there is no legal -The next of kin are informed and agree to the study and sign the consent. 6

7. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC IRB Study Protocol Financial Considerations-reimbursement acceptable for time, expenses, and the degree of discomfort during an investigation (should be reasonable) Risks and Benefits- disccuss the risks and potential benefits of the proposed study to the patient/subject, his or her family, and/or society, as well as risk/benefit ratio 7

8. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC IRB Study Protocol Consent Form: should express to the patient/subject the realistic expectations of participation in the research study -Purpose of the Study and Individual Participation –clear statement of purpose - Study and procedures- clear statements of study and procedures to be performed - Risks and benefits- clear assessment of the possible risks and discomforts of each procedure and benefits -Alternatives and Withdrawal –inform participant of alternatives and withdrawal allowed at any time -Financial Considerations (Cost Responsibility Statement)- must indicate compensation to subjects -Confidentiality Statement -Identification of Persons Obtaining Consent –show actual participant obtaining consent 8

9. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Funding Should not prevent research Research usually funded by government and private organizations Credentialing important in securing funding 9

10. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Data Collection Important- clearly describe how and by whom the data will be recorded Usually time consuming and expensive step in research Project can be jeopardize- if data cannot be understood or lost Laboratory Notebook, specialized data collection forms, and computers- multiple methods to collect data 10

11. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Laboratory Notebook Keep detailed records of the concepts, test results, and other information related to the experiment. You can start from the very first moment you think of an idea. Enter ideas, calculations. and experimental results into the notebook as soon as possible, preferably the same date they occur. Make all entries in the notebook in permanent black ink and be sure to make them as legible and complete as possible. Do not use abbreviations, code names, or product codes without defining them clearly. Draw a line through all errors. Do not erase. 11

12. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Laboratory Notebook Do not skip pages or leave empty spaces at the bottom of a page. If you wish to start an entry on a new page, draw a line through any unused portion of the previous page. Never tear out or remove a page from the notebook. You can buy a specially printed laboratory notebook or make one yourself. Use a bound notebook, because the pages cannot be added or subtracted without that being evident. Number all your pages consecutively. Draw a line across any blank pages or portion of a page left. Start a new notebook when yours is full. Assign each notebook a consecutive number. Keep your notebooks in a secure location and make records of when you take or return your notebooks from that spot. Use a header for each entry with the following information–date, project number, subject, participant(s).

13. Handbook for Health Care Research, Second Edition Chapter 8 © 2010 Jones and Bartlett Publishers, LLC Laboratory Notebook The more details, the better. Make sure that you have all the information you will need when writing up the results later. Make records of everything. Include all your tests, not just the successful ones. Add all your sketches, measurements, and computations. All loose material, such as drawings, data collection forms, printouts, photographs, etc., should be signed, dated, and cross-referenced to a particular notebook entry. If you can, tape or staple the loose material into the body of the appropriate notebook entry. Anything else, such as samples, models, and prototypes, should be carefully labeled with a date and cross-referenced to notebook entries. Keep all of it.