Polaris

SOP# IRB-009.0CompanyEffective Date: DD/MMM/YY1. Minor changes in previously approved research during the period covered by theoriginal approval:a. Where the research is permanently closed to the enrollment of new subjects;all subjects have completed all research-related interventions; and the researchremains active only for long-term follow-up of subjects; orb. Where no subjects have been enrolled and no additional risks have beenidentified; orc. Where the remaining research activities are limited to data analysis.2. Collection of blood samples by finger stick, heel stick, ear stick, or venipunctureas follows:a. From healthy, non-pregnant adults who weigh at least 110 pounds. For thesesubjects, the amounts drawn may not exceed 550 ml in an 8-week period andcollection may not occur more frequently than 2 times per week; orb. From other adults and children, considering the age, weight, and health of thesubjects, the collection procedure, the amount of blood to be collected, thefrequency with which it will be collected. For these subjects, the amountdrawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week periodand collection may not occur more frequently than 2 times per week.3. Collection of hair, nail clippings, teeth, etc. in a non-disfiguring manner4. Collection of excreta and external secretions5. Collection of uncannulated saliva collected either in an unstimulated fashion orstimulated by chewing gumbase or wax or by applying a dilute citric solution tothe tongue6. Placenta removed at delivery7. Amniotic fluid obtained at the time of rupture of the membrane prior to or duringlabor8. Recording of data from subjects age 18 or older by non-invasive procedures9. Collection of gingival plaques provided the collection procedure is not moreinvasive than routine prophylactic scaling of teeth and the process isaccomplished in accordance with accepted prophylactic techniques10. Collection of data from voice, video, digital, or image recordings made forresearch purposes11. Moderate exercise by healthy volunteers12. Research involving materials (data, documents, records, or specimens) that havebeen collected or will be collected solely for non-research purposes (such asmedical treatment or diagnosis)13. Collection of data through noninvasive procedures (not involving generalanesthesia or sedation) routinely employed in clinical practice, excludingprocedures involving x-rays or microwavesIRB-009.0.doc© 2004 by CRC Press LLC