<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Participant Rights As a Principal Investigator of a major longitudinal observational study of the biological changes anteceding menopause, you are assigned the task of determining what information from the multitude of tests run to tell the individual about and how to go about the process. You have two principles to consider: Will revealing information change behavior and thus alter the results of the study? Do the participants, deserving of respect, have a right to know about any information learned about them so they can use it to better their lives? The study will collect among other things: Study Clinical Relevance Body-mass index (BMI) Obesity Metabolic Syndrome TSH Hyper or hypothyroidism Fasting blood sugar Glucose intolerance or diabetes Depression rating scale Depression Blood pressure Hypertension MRI of brain Tumors Anomalies Atrophy Multiple sclerosis DEXA scan of spine and hip Osteoporosis Serum Lipids (APO E4 ) Hypercholesterolemia Risk for Alzheimer's Coeliad disease Carotid artery ultrasound Degree of atherosclerosis Genotype Many risks over time Many of these studies will be analyzed and reported long after the encounter with the participant. How should the study deal with abnormalities in these results and how should the issue be presented to the participants? A significant number of the participants have no personal physician. How should that situation be handled? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)