The requirements for human use are informed by guidelines for good clinical practice as outlined by the Institutional Review Board [(IRB) Brown, 2011]. In this study, the rights and well-being of patients are a priority and will transcend societal and scientific interests. Each subject will obtain informed consent before participating in the research. This consent will cover the study’s nature and will encompass the review of information obtained from clinical records. We will inform patients of the samples to be extracted from their blood for use in experimental studies. The patients are assured of access to results following analysis of the specimens and will remain sure of their confidentiality.
Consent procedure
Patients will receive consent forms with an allowance of 24 hours to help them reflect on the information contained herein. They will receive this alongside an explanation of the research. Information sheets will contain appointment letters, which are available at the relevant clinics. For those who need more time to consult before agreeing to take part, we will defer their visits to later dates. We will approach those who agree to participate and who meet the study criteria in a friendly way. According to Marshall (2007), only qualified research members or lead investigators are allowed to obtain consent from participants. In our study, this personnel will explain the objectives of the study to the patients, before informing them of the risks of participation. The decision-making process will remain free of coercion of pressure and participants are free to withdraw at their free will. If we discover that we have an enrolled patient who does not meet the inclusion criteria, we will document this clearly and inform the principle investigator.
Ethical Considerations
There are few ethical issues involved in instances where patients in a study already have the disease in them (Wear, 2012). We will inform the patients of ethical issues such as the possibility of no therapy for the identified disease. In this scenario, we will balance the significance of telling an individual their status with the possibility of whether they would like to know intervention potentials. If there is a potential for intervention, we will write a letter to all family members informing them of our findings in a non-medical language. We will then invite all the participants in the study to discuss the results. A counselor will be present prior to this, to confirm the tests, before discussing them with appropriate detail. We will also make an appropriate screening with a care plan at this stage.
Confidentiality
Each consent form should have a unique patient identifier consisting of a unique pre-generated number (Wear, 2012). For our study, this will uniquely identify patient samples and the clinical data outside study sites. Samples of the codes include Beaumont, BH, or Tallaght, TA. Identifiable patient information will remain on-site while the collected samples and data receive a unique identifier to aid in coding. The data will remain store in a secured folder, only accessible to the lead investigator or research nurse. All our procedures will undergo scrutiny to ensure that they are consistent with participant’s consent. We will also ensure that they are the relevant ethics approval and that they are grounded on sound science.
Consent Agreement
Appending your signature below shows that you agree with the requirements of the research. It means that you understand the information listed above and that your concerns have been addressed satisfactorily. This also means that you agree to the responsibilities indicated above and that you will participate in the research to your ability. This informed consent will be part of my records.
Name of the participant____________________
Signature____________________
References
Brown, B. J. (2011). Informed Consent: The U. S. Medical Education System Explained. North Charleston, US: CreateSpace.
Marshall, P. L. (2007). Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings. Geneva, Switzerland: World Health Organization.
Wear, S. (2012). Informed Consent: Patient Autonomy and Physician Beneficence within Clinical Medicine. Berlin, Heidelberg: Springer Science & Business Media.