Informed consent confidentiality

Regulations also exist to protect the confidentiality of the research participant. All information collected throughout the clinical trial remains with the study staff. For the purposes of data capture, each subject is identified by initials or study number only. In addition, the informed consent discusses who will have access to the trial documents. 

Then there are questions of ethics, patient confidentiality, informed consent and ethics committee approval to be addressed, as well as the whole... 

Informed consent is in some sense the ethical cornerstone on which human subjects protection rests. It requires that individuals understand their part in a study and the potential consequences, and are free to choose to participate. As Levine has argued, the consent process should include specific elements an invitation to participate a statement of the purpose of the study the basis of participant selection and explanation of procedures, risks, and discomforts how untoward consequences will be handled the benefits of participation alternatives to participation financial consideration confidentiality opportunities for continuing disclosure and measures for ensuring that a person s decision to participate is voluntary (Levine, 1981). 

Engineers shall not disclose, without consent, confidential information concerning the business affairs or technical processes of any present or former client or employer, or public body on which they serve. 

Recommendation There is a need for review of the bioethical issues confronting the future of biomonitoring, including confidentiality, informed consent, reporting of results, and public-health or clinical followup. 

An essential element of any medical program is informed patient consent prior to the performance of any test or procedure. Although informed consent is not specifically mentioned in the ACOEM components of occupational and environmental health programs, it is inherent in the ethical practice of medicine. The ACOEM Code of Ethical Conduct (adopted October 25,1993) states that physicians should relate honestly and ethically in all professional relationships. Also, the Association of Occupational and Environmental Clinics has issued guidance relative to patient consent, confidentiality of medical records, and communication of the results of tests and procedures (AOEC, 1987). 

IRBs are concerned with which of the following a clinical trial design b informed consent c proper enrollment criteria d confidentiality of participants e all of the above. 

The research was conducted in accordance with the Statement of Ethical Practice of the British Sociological Association with regard to informed consent, anonymity and confidentiality. Data collected from the interviews were presented as general statements resulting from the analysis. 

Setting up clinical studies is a lengthy process, as there are many documents to prepare [e.g. protocols and case report forms (CRFs)], study facilities to be assessed (e.g. study sites, CROs, clinical laboratories, phase I units), regulatory review to be considered and negotiations and agreements with study sites (e.g. contracts, finances, confidentiality, indemnity, insurance) to be undertaken. In addition, as will be dealt with in subsequent sections, ethical aspects of the study must be considered (e.g. ethics committee and IRB review and informed consent requirements), and study medications/devices must be organized. 

This summary of the Policy is divided into ten sections similar to the original document ethics review free and informed consent privacy and confidentiality conflict of interest inclusion/exclusion of populations aboriginal peoples clinical trials human genetics research research involving human gametes, embryos, or fetuses and human tissue. 

The need for privacy when participating in research is based upon a subject s dignity and autonomy and thus warrants respect. As a result, all information regarding a research subject must be kept confidential. The researcher has a duty not to share any information without a subject s free and informed consent. Respect for privacy is an internationally recognized ethical standard and is reflected in Canadian law as a constitutional right. However, there are some circumstances where public health and safety require protection and such privacy may be lost, e.g., child abuse, sexually transmitted diseases. The REB can play an important role in assessing the balance between the need for research versus invasion of privacy, thus protecting individuals from harm as a result of unauthorized use of personal information. 

When data are used for purposes other than the research for which they were collected, REB approval must be sought if individuals are identifiable. Researchers must demonstrate that knowledge of the subjects identities is necessary for the current use, that confidentiality will be maintained and that the involved individuals have not objected. If deemed appropriate, the REB may require either informed consent from those who contributed the data, an appropriate strategy for informing subjects, or consultation with representatives of those who contributed the data. REB approval is also required for situations when a researcher wishes to contact individuals to whom data refers. Linkage of databases where research subjects may be identifiable requires REB approval. 

It is important to establish and agree on ownership of laboratory specimens, X rays, and medical records on who is to store them and for how long and on who may have access to them in the future. It may be desirable for the voucher agency to retain intellectual property rights of all data for all studies and publications. Patient confidentiality must be respected at all times, but the voucher agency may want to request access to medical records for supervision or study purposes. If the voucher scheme incorporates a research component involving human subjects, it is essential to obtain approval from the appropriate bodies and, if necessary, informed consent from the patients. 

Undeniably, genomics and pharmacogenomics opens up a whole host of legal, ethical, and societal issues that will have implications in patient confidentiality, discrimination, malpractice, and informed consent (135-137). However, as clinicians, scientists, and health care practitioners, we must always remember the unquestionable power of an individual s right to choose, and prospectively fight to ensure patients rights and prevent genomic discrimination. 

A confidentiality statement or agreement A sample informed consent form... 

Security services will be provided for applications to apply appropriate business rules for access control of records based on the identity, roles, and purposes (i.e., business functions), in addition to distributed security services for authentication, authorization, confidentiality, integrity and nonrepudiation, to protect the best interests of stakeholders. Later in this book we will discuss the notion of a stakeholder in healthcare. It suffices here to say that these are the people legitimately involved in healthcare such as the patient, physician, and emergency medical staff. In some definitions stakeholders are the only people who can access the patient record. There are usually a special provisionings for the emergency care staff to access the patient data without an explicit informed consent in the event that the patient is unconscious. 

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