Medical Writing - Ethical and Legal Considerations

 

The practice of medical writing is gaining remarkable popularity in the global scenario. With an appreciation in the rate of submissions, companies offering these services are looking for trained and experienced writers and consultants in this field, who posses the caliber to project the standard of client satisfaction on higher levels. The efficiency flowing into this professional stream, promises a brighter and strategically stable future for this industry. But the emergence of certain negative trends in the practice of this profession poses a threat to its ability to deliver quality contents with reliable information. Writers and clients linked on the basis of medical writing need to observe the mandatory ethical and legal considerations that could assist them in the attainment of their desirable targets.

 

Ethical issues are the concerns that address subjects like, content reliability, data collection techniques and presentation tactics, marketing strategy and the relevance of research and development. They play a vital role in relieving the writers of regulatory pressures involved in the process. It is difficult to give them an exact definition but in the words of John Dirckx, author of ‘A Physician’s Guide To Medical Writing’, an ideal medical write up framed along ethical considerations,” properly includes technical exposition on any subject related to medical science, such as biochemistry, pharmacologic studies, sanitation and psychoanalysis”. It is the responsibility of the writer to include necessary technical details under regulatory limitations to establish a level of understanding among the readers. Such ethical responsibilities have to be shared by the writer as well as the client. Some ethical considerations to be observed by a client are:-

• The client or the researcher should generate complete information on the academic background of the writer before allotting the assignment. This helps a client to understand the performance level that could be extracted from a writer.
• Regular communication with the writer is an essential condition for the correct formulation of the content.
• It is pivotal for a client to allow proper validation of the content written for him before mass circulation.

Writers engaged in the regular practice of medical writing should pay heed to the following responsibilities at hand:-

• A writer should survey the medical journals and books cognate to the subject of the research or medical issue, to accumulate sufficient information that helps him to plan the elements of the content.
• The writer should record the core functions of the research in an appropriate manner.
• Abstracts should include tables, statistics and flow-charts to make the content interpretable for a layman.
• Content writer should give appropriate acknowledgement to the participants in case of developing an accurate write-up for clinical trials.
• Medical content cannot be entertaining but it should be thought-provoking and encourage the people to discuss the future prospects of an experiment.
• Abstracts should explain the methods adopted and the treatment provided at each stage of the research. Every detail should be explained on the basis of GCP (Good Clinical Practices) regulations.
• Glossaries should be an integral part of content formulation.
• Writers should design the style sheets in accordance with the expectations of the client and the nature of the research. MLA (Modern Language Association) Handbook serves as a useful reference in this case.

 

Legal issues go hand-in-hand with ethical considerations. A major share of legal considerations should be understood and applied by the writer while working on medical write-ups. Some important considerations are:-

 

• Ownership Rights- The client should purchase the ownership rights of an abstract written for him. This prevents duplication of the content delivered to him and grants an individual and exclusive identity to the research presentation.
• Plagiarism- The writer is accountable to the client in case of plagiarism. Once a client secures the copyright for content, he is the sole owner of the abstract and if a copyright content is used by the writer for the benefits of other organizations, he is deemed to be punished under the prevailing set of laws for this category.
• A medical write-up should be formulated on the basis of elements that are complimentary to the regulations in effect. Violation of regulatory affairs can lead to the rejection of proposals submitted to regulatory organizations such as FDA (food and drug administration).
• Writers should place incomplete abstracts under confidentiality to protect the interests of the clients.
• It is the duty of the writer to track the budget of a research project and record the cost of every procedure while designing the content for the purpose of submission.
• Identification of informatory sources is necessary to avoid falsification of the data provided.
• Validation of the content should be certified by professionals other than the writers involved in developing the content.

 

Ethical and legal considerations enhance the quality and reliability of the content. It is true that the technical aspects in the profession of medical writing demand constant attention and need to be presented with clarity. In absence of such considerations it will be impossible for the clients to bridge the communication gaps between them and the target audience. It is widely accepted by many researchers that legal and ethical issues can play the role of obstacles in the progress of marketing a research as they impose certain limitations on the utilization of research products. But it is important to remember that appropriate observance of these issues can bring momentum in research activities along with assured standards of safety.