Ethical Informed Consent Considerations for Research in Severe Mental Illness

Study Objective: The objective of this integrative review is to update researchers on the clinical and ethical considerations that are shaping the current understanding of informed consent for research participants with a severe mental illness (SMI). METHOD: A literature search was performed within the last 5 years in the following databases: Legal Collection, MasterFile Premier, MEDLINE, and PsycInfo. Nineteen articles focusing specifically on the ethical issues surrounding conducting research involving individuals with SMI were included. RESULTS: Individuals with SMI have a greater likelihood to be at risk for incapacity in making informed consent. Informed consent should be based on the clinical features of SMI and on evolving legal understandings of informed consent as an individual’s right, regardless of societal or health status. To hold the preconception that individuals with a certain psychiatric disorder do not have decision making capabilities violates their autonomy, re-enforces stigmatization, and unreasonably neglects the potential research contributions of this population. Several instruments can serve as tools to aid in determining capacity in research. Instruments vary by administration length, administrator training, and measurement OBJECTIVE: Additional strategies to improve capacity include iterative approach, discussion, use of technology, and continuous monitoring of symptoms and severity of the psychiatric illness. CONCLUSIONS: These strategies enhance the capacity of the participant and reduce the risk for coercion. Based on the information presented, informed consent is highly achievable for SMI research participants. What is This Lump? Risk of Renal and Salivary Stone Formation with Topiramate (Topamax) Treatment Amber V.K. Buhler, PhD; Pearl Huynh, PharmD; Pauline A. Low, RPh, PharmD; and Mary E. Von, DHEd, MS, PA-C 1 School of Pharmacy, Pacific University, Oregon 2 School of Physician Assistant Studies, Pacific University, Oregon ABSTRACT: Topamax, originally approved as an antiepileptic, is being used increasingly for bipolar, migraine, and even weight-loss treatment. Topamax is best recognized for its neuronal inhibitory effect, however it is also a strong inhibitor of carbonic anhydrase. At therapeutic doses this action regularly causes acid/base imbalance and mild metabolic acidosis. It is established that Topamax treatment increases risk of renal lithiasis, however the closely associated sialolithiasis has not been documented. This case study describes a migraine patient on Topamax treatment who presented with a submandibular sialolith, likely a result of increased calcium deposition in the salivary gland due to increased serum and salivary carbonic acid levels with resulting decreased pH and solubility of calcium. This case highlights a poorly discussed adverse event profile of Topamax, an agent increasingly used in neurology and even general practice. This report suggests that patients receiving Topamax should be monitored for signs and symptoms of renal and salivary stone formation and other consequences of acid/base imbalance. doi:10.1017/S1092852914000765 Topamax, originally approved as an antiepileptic, is being used increasingly for bipolar, migraine, and even weight-loss treatment. Topamax is best recognized for its neuronal inhibitory effect, however it is also a strong inhibitor of carbonic anhydrase. At therapeutic doses this action regularly causes acid/base imbalance and mild metabolic acidosis. It is established that Topamax treatment increases risk of renal lithiasis, however the closely associated sialolithiasis has not been documented. This case study describes a migraine patient on Topamax treatment who presented with a submandibular sialolith, likely a result of increased calcium deposition in the salivary gland due to increased serum and salivary carbonic acid levels with resulting decreased pH and solubility of calcium. This case highlights a poorly discussed adverse event profile of Topamax, an agent increasingly used in neurology and even general practice. This report suggests that patients receiving Topamax should be monitored for signs and symptoms of renal and salivary stone formation and other consequences of acid/base imbalance. doi:10.1017/S1092852914000765