Adams P, Wongwit W, Pengsaa K, Khusmith S, Fungladda W, Chaiyaphan W, Limphattharacharoen C, Prakobtham S, Kaewkungwal J (2013). Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand. BMC Medical Ethics
Appelbaum PS (2006). Decisional capacity of patients with schizophrenia to consent to research: taking stock. Schizophrenia Bulletin
Appelbaum PS (2007). Assessment of patients’ competence to consent to treatment. New England Journal of Medicine
Appelbaum P, Grisso P, Hill-Fotouhi C (1997). The MacCAT-T: a clinical tool to assess patients’ capacities to make treatment decisions. Psychiatric Services
Beauchamp TL, Jennings B, Kinney ED, Levine RJ (2002). Pharmaceutical research involving the homeless. The Journal of Medicine and Philosophy
Bernabe RD, Van Thiel GJ, Van Delden JJ (2016). What do international ethics guidelines say in terms of the scope of medical research ethics?
BMC Medical Ethics
Buxton M, Hanney S, Jones T (2004). Estimating the economic value to societies of the impact of health research: a critical review. Bulletin of the World Health Organization
Chambers M, Gallagher A, Borschmann R, Gillard S, Turner K, Kantaris X (2014). The experiences of detained mental health service users: issues of dignity in care. BMC Medical Ethics
Charles A, Rid A, Davies H, Draper H (2016). Prisoners as research participants: current practice and attitudes in the UK. Journal of Medical Ethics
Conus P, Berk M, Cotton S, Kader L, Macneil C, Hasty M, Hallam K, Lambert M, Murphy B, McGorry P (2015). Olanzapine or chlorpromazine plus lithium in first episode psychotic mania: an 8-week randomised controlled trial. European Psychiatry
Council for International Organizations of Medical Sciences (2007). International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS: Geneva2002. In External Resources Pubmed/Medline (NLM).
Cummings JL, Lyketsos CG, Peskind ER, Porsteinsson AP, Mintzer JE, Scharre DW, Jose E, Agronin M, Davis CS, Nguyen U (2015). Effect of dextromethorphan-quinidine on agitation in patients with Alzheimer disease dementia: a randomized clinical trial. JAMA
da Conceicao PO, Nascimento PP, Mazetto L, Alonso NB, Yacubian EMT, de Araujo Filho GM (2013). Are psychiatric disorders exclusion criteria for video-EEG monitoring and epilepsy surgery in patients with mesial temporal sclerosis?
Epilepsy & Behavior
de Jonghe A, van de Glind EM, van Munster BC, de Rooij SE (2014). Underrepresentation of patients with pre-existing cognitive impairment in pharmaceutical trials on prophylactic or therapeutic treatments for delirium: a systematic review. Journal of Psychosomatic Research
European Commission (2009). Challenging futures of science in society: emerging trends and cutting-edge issues. Monitoring Activities of Science in Society Expert Group European Commission, Brussels.
European Council (2001). Directive 2001/20/EC Additional protocol to the convention on human rights and biomedicine, concerning biomedical research Regulation (EU), No 536/2014. European Council.
European Parliament, Council of the European Union (2014). Clinical trials on medicinal products for human use. No. 536/2014 OJ L158. European Council.
Eynan R, Bergmans Y, Antony J, Cutcliffe JR, Harder HG, Ambreen M, Balderson K, Links PS (2014). The effects of suicide ideation assessments on urges to self-harm and suicide. Crisis
Fertig E, Fureman BE, Bergey GK, Brodie MA, Hesdorffer DC, Hirtz D, Kossoff EH, LaFrance WC, Versavel M, French J (2014). Inclusion and exclusion criteria for epilepsy clinical trials – recommendations from the April 30, 2011 NINDS workshop. Epilepsy Research
Førde R, Norvoll R, Hem MH, Pedersen R (2016). Next of kin’s experiences of involvement during involuntary hospitalisation and coercion. BMC Medical Ethics
Freedman B, Fuks A, Weijer C (1992). Demarcating research and treatment. Clinical Research
Frew PM, Saint-Victor DS, Isaacs MB, Kim S, Swamy GK, Sheffield JS, Edwards KM, Villafana T, Kamagate O, Ault K (2014). Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices. Clinical Infectious Diseases
Fry C, Dwyer R (2001). For love or money? An exploratory study of why injecting drug users participate in research. Addiction
Gurrera RJ, Karel MJ, Azar AR, Moye J (2007). Agreement between instruments for rating treatment decisional capacity. The American Journal of Geriatric Psychiatry
Gysels M, Shipman C, Higginson IJ (2008). Is the qualitative research interview an acceptable medium for research with palliative care patients and carers?
BMC Medical Ethics
Hall S, Longhurst S, Higginson IJ (2009). Challenges to conducting research with older people living in nursing homes. BMC Geriatrics
Head MG, Walker SL, Nalabanda A, Bostock J, Cassell JA (2015). Researching scabies outbreaks among people in residential care and lacking capacity to consent: a case study. Public Health Ethics, Published online 16 April 2015. doi:10.1093/phe/phv011.
Hietanen P, Aro AR, Holli K, Absetz P (2000). Information and communication in the context of a clinical trial. European Journal of Cancer
Humphreys K (2014). A review of the impact of exclusion criteria on the generalizability of schizophrenia treatment research. Clinical Schizophrenia & Related Psychoses
Humphreys K, Weisner C (2000). Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies. American Journal of Psychiatry
Kirino S, Suzuki T, Takeuchi H, Mimura M, Uchida H (2017). Representativeness of clinical PET study participants with schizophrenia: a systematic review. Journal of Psychiatric Research
Kleiderman E, Avard D, Black L, Diaz Z, Rousseau C, Knoppers BM (2012). Recruiting terminally ill patients into non-therapeutic oncology studies: views of health professionals. BMC Medical Ethics
Kost RG, Lee LM, Yessis J, Wesley RA, Henderson DK, Coller BS (2013). Assessing participant-centered outcomes to improve clinical research. The New England Journal of Medicine
Lecouturier J, Rodgers H, Ford GA, Rapley T, Stobbart L, Louw SJ, Murtagh MJ (2008). Clinical research without consent in adults in the emergency setting: a review of patient and public views. BMC Medical Ethics
Li RH, Wacholtz MC, Barnes M, Boggs L, Callery-D’Amico S, Davis A, Digilova A, Forster D, Heffernan K, Luthin M (2016). Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. Journal of Medical Ethics
Locock L, Smith L (2011). Personal experiences of taking part in clinical trials – a qualitative study. Patient Education and Counseling
Maas AI, Steyerberg EW, Marmarou A, McHugh GS, Lingsma HF, Butcher I, Lu J, Weir J, Roozenbeek B, Murray GD (2010). IMPACT recommendations for improving the design and analysis of clinical trials in moderate to severe traumatic brain injury. Neurotherapeutics
Marson DC, Ingram KK, Cody HA, Harrell LE (1995). Assessing the competency of patients with Alzheimer’s disease under different legal standards: a prototype instrument. Archives of Neurology
McDonald K, Kidney C, Patka M (2013). ‘You need to let your voice be heard’: research participants’ views on research. Journal of Intellectual Disability Research
Misra S, Socherman R, Hauser P, Ganzini L (2008). Appreciation of research information in patients with bipolar disorder. Bipolar Disorders
Moore A, Donnelly A (2015). The job of ‘ethics committees’. Journal of Medical Ethics, Published Online 13 November 2015. doi: 10.1136/medethics-2015-102688.
Moore LW, Miller M (1999). Initiating research with doubly vulnerable populations. Journal of Advanced Nursing
Morán-Sánchez I, Luna A, Sánchez-Muñoz M, Aguilera-Alcaraz B, Pérez-Cárceles MD (2016). Decision-making capacity for research participation among addicted people: a cross-sectional study. BMC Medical Ethics
National Institute for Health and Care Excellence (2011). Service user experience in adult mental health: improving the experience of care for people using adult NHS mental health services: Clinical guideline [CG136]: Research Recommendations.
National Institute for Health and Care Excellence (2015). Violence and aggression: short-term management in mental health, health and community settings: NICE guideline [NG10]: Research Recommendations.
Newman E, Walker EA, Gefland A (1999). Assessing the ethical costs and benefits of trauma-focused research. General Hospital Psychiatry
Office of the Minister for Children and Youth Affairs. (2010). Ethical Review and Children’s Research in Ireland. The National Children’s Strategy Research Series. The Stationery Office: Dublin.
Olsen DP, Mahrenholz D (2000). IRB-identified ethical issues in nursing research. Journal of Professional Nursing
Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Daniel Ayers G, Herbst RS, Abbruzzese JL (2002). Study of the media’s potential influence on prospective research participants’ understanding of and motivations for participation in a high-profile phase I trial. Journal of Clinical Oncology
Porteri C, Petrini C (2015). Research involving subjects with Alzheimer’s disease in Italy: the possible role of family members. BMC Medical Ethics
Reijula E, Halkoaho A, Pietilä A-M, Selander T, Kälviäinen R, Keränen T (2015). Therapeutic misconception correlates with willingness to participate in clinical drug trials among patients with epilepsy; need for better counseling. Epilepsy & Behavior
Roberts LW (1998). The ethical basis of psychiatric research: conceptual issues and empirical findings. Comprehensive Psychiatry
Roberts LW, Roberts B (1999). Psychiatric research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness. Biological Psychiatry
Rogers B (1990). Ethics and research. AAOHN Journal
Rose D, Russo J, Wykes T (2013). Taking part in a pharmacogenetic clinical trial: assessment of trial participants understanding of information disclosed during the informed consent process. BMC Medical Ethics
Sanci LA, Sawyer SM, Weller PJ, Bond LM, Patton GC (2004). Youth health research ethics: time for a mature-minor clause?
Medical Journal of Australia
Schneider LS, Olin JT, Lyness SA, Chui HC (1997). Eligibility of Alzheimer’s disease clinic patients for clinical trials. Journal of the American Geriatrics Society
Schwenzer KJ (2008). Protecting vulnerable subjects in clinical research: children, pregnant women, prisoners, and employees. Respiratory Care
Shepherd V (2016). Research involving adults lacking capacity to consent: the impact of research regulation on ‘evidence biased’ medicine. BMC Medical Ethics
Sigman GS, O’Connor C (1991). Exploration for physicians of the mature minor doctrine. The Journal of Pediatrics
Staphorst MS, Hunfeld JA, van de Vathorst S (2017). Are positive experiences of children in non-therapeutic research justifiable research benefits?
Journal of Medical Ethics
Sutton LB, Erlen JA, Glad JM, Siminoff LA (2003). Recruiting vulnerable populations for research: revisiting the ethical issues. Journal of Professional Nursing
Ulrich CM, Wallen GR, Grady C (2002). Research vulnerability and patient advocacy: balance-seeking perspectives for the clinical nurse scientist? Nursing Research
UyBico SJ, Pavel S, Gross CP (2007). Recruiting vulnerable populations into research: a systematic review of recruitment interventions. Journal of General Internal Medicine
Vallely A, Lees S, Shagi C, Kasindi S, Soteli S, Kavit N, Vallely L, McCormack S, Pool R, Hayes RJ (2010). How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Medical Ethics
van Lent M, Rongen GA, Out HJ (2014). Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review. BMC Medical Ethics
Van Spall HG, Toren A, Kiss A, Fowler RA (2007). Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA
Verástegui EL (2006). Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico. BMC Medical Ethics
Wang S-B, Wang Y-Y, Ungvari GS, Ng CH, Wu R-R, Wang J, Xiang Y-T (2016). The MacArthur Competence Assessment Tools for assessing decision-making capacity in schizophrenia: a meta-analysis. Schizophrenia Research
Welch MJ, Lally R, Miller JE, Pittman S, Brodsky L, Caplan AL, Uhlenbrauck G, Louzao DM, Fischer JH, Wilfond B (2015). The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clinical Trials
Willison DJ, Steeves V, Charles C, Schwartz L, Ranford J, Agarwal G, Cheng J, Thabane L (2009). Consent for use of personal information for health research: do people with potentially stigmatizing health conditions and the general public differ in their opinions?
BMC Medical Ethics
Woolfall K, Frith L, Gamble C, Young B (2013). How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials. BMC Medical Ethics
World Medical Association (2001). World Medical Association, Declaration of Helsinki: Ethical principles for medical research involving human subjects. Bulletin of the World Health Organization
Yamal J-M, Robertson CS, Rubin ML, Benoit JS, Hannay HJ, Tilley BC (2014). Enrollment of racially/ethnically diverse participants in traumatic brain injury trials: effect of availability of exception from informed consent. Clinical Trials
Yanos PT, Stanley BS, Greene CS (2009). Research risk for persons with psychiatric disorders: a decisional framework to meet the ethical challenge. Psychiatric Services