Ownership of data

Sorting out the ethical issues in relation to conducting research in disasters is a worthwhile starting point. Ownership of data can be an issue. If data are collected in a community that has just experienced a disaster, the data belongs to that community. They should have first call on the dissemination and implementation of findings. Just as in mainstream health care research where participants in the form of patient groups are heavily involved in research so too should be the case in disaster research. Nurses are in a prime position to develop this process whether they wish to use an action research approach or carry out projects that are immedi-... 

The challenges for data integration for clinical genomics are these the data to be accessed are multidimensional and heterogeneous, the majority of data are unstructured and exist in natural language text, the data contains personal information that is subject to statutory requirements for protection of privacy, the ownerships of data lie with multiple stakeholders in multiple organizations,... 

Ownership of data by production personnel Control of priorities Data can be of poor quality... 

Workforce Support for Data Collection and Incident Analysis Systems Few of the incident investigation and data collection systems reviewed provide any guidelines with regard to how these systems are to be introduced into an organization. Section 6.10 addresses this issue primarily from the perspective of incident reporting systems. However, gaining the support and ownership of the workforce is equally important for root cause analysis systems. Unless the culture and climate in a plant is such that personnel can be frank about the errors that may have contributed to an incident, and the factors which influenced these errors, then it is unlikely that the investigation will be very effective. 

There is no substitute for the chemist s intuition. The bench chemist should personally perform the primary analysis of the theoretical data and possibly the data generation itself, as long as the chemist understands that this method is not a miracle solution (and will not replace him or her). Ownership of the problem will often mean that the bench scientist is eating, sleeping and drinking the problem. This is the person who has the most insight into the problem and this is the person you want to look at the molecular graphics and the probe surfaces. 

All personnel involved in GMP production of drugs have to take ownership of quality. It is a requirement that processes and equipment for drug manufacturing must be approved and operated by trained, qualified personnel. Quality-related activities have to be recorded to enable traceability of data and information. Deviations and excursions of processes and results from specified conditions or criteria have to be reported, investigated, and resolved. Drug products have to be tested and must meet specifications before being... 

In the past, various individuals and organisations have claimed to own the data produced from a clinical trial, including the state, the sponsor, the investigator and, in some cases, the patient or study subject. It is certainly true that with the advent of the EU Directive on Data Protection, the claim of ownership to his or her data by the patient or study subject has been strengthened. Unfortunately, there is no clear ownership of clinical data except that of society. Even then, society needs to respect the confidentiality and other wishes of individual subjects who have been clinical trial participants. Is there a difference in ownership between data produced from product-driven research to that produced in policy-driven therapeutic research ... 

Financial data and other corporate information can change quickly. A book of this type can be no more current than the data that was available as of the time of editing. Consequently, the financial picture, management and ownership of the firm(s) you are studying may have changed since the date of this book. For example, this almanac includes the most up-to-date sales figures and profits available to the editors as of late-2008. That means that we have typically used corporate financial data as of the end of 2007. 

Companies are now storing millions of biological samples from trials as they have realized that these may help them to understand side effects and to limit the dmg s use to those that will benefit, make it safer, and keep it on the market. What else they learn from these biological samples, and who owns that knowledge legally and morally, may be less certain. Companies that sell clinical samples and data are an important part of dmg discovery, insurance rate determinations, hospital design, and so on and hopefully retain legal and ethical ownership of the human samples sold. 

Data Architecture with details of the sources, uses, and ownership of each static data item System landscape showing the interactions of the various instances of the application Interfaces with diagrams (including networks, systems, and analytical equipment)... 

The Data Handling and Record Retention section of the protocol will address the requirement to maintain data (whether on a paper CRF or using an electronic data collection tool (DCT)) of each trial subject. It will address expectations of ownership of the completed CRF data, the investigator s responsibility to ensure accuracy and completeness of data recording. This section will also address the requirements for retention of records at the trial site in accordance with relevant guidelines and regulatory requirements. 

Review the final clinical report, and sign and date the signature page after review Allow an independent audit and/or inspection of all study documents and facilities Agree to the publication policy Agree to the sponsor s/CRO s ownership of the data... 

Privacy concerns are becoming more important as data mining becomes more common. Besides issues of data ownership, there are questions that abound on who has access to the data, the amount of identifying information that is present in the database and how the results of the data mining will be used. 

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. 

The process of data summarization, encompassing both medical interpretation and scientific writing, can be one of the more challenging aspects of a clinical program. The greater the level of sponsor involvement in these activities, the more internal ownership is reinforced and the sponsor is better able to defend the data. This is not to say that CROs cannot play an important role in these steps. Contract research organizations that have medically trained personnel with expertise in particular therapeutic areas can be an excellent resource for small companies that may have no internal medical staff. 

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