Drug Lit

• review articles
• text books
• facts and comparisons
• micromedex
• lexicomp and epocrates

can have author bias/book lag time

• medline
• pubMed
• IPA

• New England Journal of Medicine
• Pharmacotherapy
• AJHP
• JAMA
• Disease specific journals 

most direct source!

• submissiong and approval by editorial board
• forwarded on to experts for clinical significance
• recommendations to editor
• publication

all primary lit are peer reviewed!!!

• anyone with internet access can make
• edited by anyone 
• editors are always working to advise obvious errors 

• are these results believable
• are the results applicable to my practice
• will the pt respond in the same way as those in the clinical trials
• dose the article support its claim

• abstract= summary
• introduction= why
• methods= how
• results= what
• discussion= means

• summart of literature review and background of drug or disease state currently 
• motivation for the study
• objective of study is last sentence of this section 

• type data and using right study
• critical in evaluating the validity of the study
• should be able to reproduce the study

• study design
• patient population
• mehods for recruitment
• inclusion and exclusion
• data collection and measurement methods
• primary and secondary outcome measures
• stats 

• need to be consistent with the methods section
• provides data (charts, tables)
• analysis of research findings and you can draw your own conclusions

• Authors comments on the results
• compare data to other published work
• strengths and limitations to the study
• further options of studies

• who the author is and what their cridentials/affiliations 
• funding interaction in study 
• journal type (want a peer reviewed)
• references and completeness 

• scan the article to gain a quick overview 
• concentrate on the methods section and design and analysis of the study
• keep the final judgement for yourself 
• consider limitations!! 

syphilis study at Tuskegee

legislation mandated regulations to protect human subjects from treatment options (ethical issues with using human subjects)

created the Belmont report 

ethical principles and guidelines for the protection of human subjects of research

• Respect
• Beneficience
• Justice

• informed consent to protect those that cannot make decisions 
• pregnane women, elderly

free chhoice to participate

assessment of benefits and risks

• do best to ensure no harm and minimize risks 
• intramanalysis- protect the pt and stop if they have SE 

• equitable distribution of burdens and benefits
• stidy includes all groups that may benefit and not select one out 
• equal selection and fairly distributed in population 

committee charged with reviewing the human participants research that humans are are adequately protected 

data through internevtion or interaction with the individual 

• 5 or more members with varying backgrounds 
• must be qualified
• at least 1 member not affiliated with the organization and non scientist 

• protect human subjects
• minimize risks and mak benefits
• procedures for obtaining informed consent are adequate
• subject selection is equitable
• safequard for vulnerable subjects

violations jepardize funding

• those under 18 years
• pregnant
• frail and elderly
• incarcerated or those under correctional sentences
• mentally impaired 

• Minimal risk and all study procedures fall into:
• educational test
• survey or interviews 
• observation of public behavior
• existing documents (retrospective study)
• federal benefit
• taste and food quality and conusmer acceptance study

• inclusion of vulnerable pop cannot be exempt
• review coordinated by IRB director

• minimal risk and all study procedures fall into:
• device but will not come in contact with living body
• non invasive tissue collection 
• non invasive prospective collection of biological specimens
• research involving materials that have been collected for non research purposes
• collection of voice, video or digital image 
• research individual or group behavior 
• continuing review

• non vulnerable populations
• reviewed by only 1 member

• administer anything to anyone
• does not meet exemption or expedited

• vulnerable populations 
• all members review and decision based on majority 
• no member with conflict of interest can participate

• approval
• modifications required for approval
• disapproval
• withdrawal or suspension of an earlier approved 

• written at a 6th grade reading level and medical terms explained
• allows subjects to consider to participate or not
• does not waive legal rights
• details on termination 

• 1- statement that the study involves research
• 2- reasonable forseeable risks and discomforts from animal studies
• 3- reasonable forseeable benefits
• 4- appropiate alternative procedures and treatments
• 5- statement describing extent of confidentiality
• 6- compensation for research related injury
• 7- whom to contact to answer questions and subject rights
• 8- statement that participation is voluntary