DDHA 8600 Week 9 part 2
Post and describe the implications of having patients participate in a clinical research study without adequate informed consent.
Then, explain how you, as a current or future healthcare administration leader, might address patient concerns about informed consent, including what strategies you might take to reduce risks of litigation.
The implication of Poor Informed Consent
Informed consent is one of the most significant aspects of research ethics. Regulations
necessitating informed consent have been declared to protect the human subjects participating in
clinical research. The basic ethical principle behind informed consent authorities is to protect the
autonomy of human subjects which asserts that the welfare and interests of a subject
participating in clinical research are constantly above the society's interests and welfare. Medical
research directed towards treatment advances for society's benefit and betterment can never be
built on limiting the rights and health of research participants (Bhatt, 2015).
The clinical research investigator and the sponsor should concentrate on interventions to
improve research participants' understanding of information published in the informed consent
process. There is proof to suggest that the use of multimedia and enhanced consent forms would
have simply limited success in improving the comprehension of clinical research participants.
The most effective approach to develop an understanding of patients/participants is increased
person-to-person interaction by a study team member or an external educator (Gupta.
2013). Creating awareness about clinical research in society and educating clinical trial
participants is crucial in improving the quality of informed consent and fostering informed
choice regarding participation in clinical research
Reducing Risks of Litigation
Over 42% of all physicians and a startling 57% of physicians in surgical sub
specialties have been sued. Nearly 61% of physicians aged 55 or older have faced the ordeal of a
lawsuit. Current literature has shown that patient frustration often is rooted in an expectation of
clinical results that do not match actual outcomes. To alleviate the disparity, the use of a
standardized informed consent process to ensure patients thoroughly understand the procedure
and possible outcomes (Nijhawan & Janodia, 2007). Furthermore, there is a need for key steps to
be taken to reduce the risk of litigation, such actions are:
Raise Awareness
For example, the sharing of readable informed Health Insurance Portability and
Accountability Act (HIPAA) consent and authorization documents that have been used
successfully by other IRBs. Conduct interactive workshops and online training on writing
understandable documents and how to conduct the informed consent and authorization
discussion (Wortz, 2018). All this can lead to creating a forum to discuss ways to identify and
address liability concerns outside the informed consent and authorization process
Identify Leaders and Partners
Health organizations must Invite researchers and IRB officials from other communities or
institutions such as the Association for the Accreditation of Human Research Protection
Programs (AAHRPP) to model new approaches and demonstrate that changing the process for
obtaining informed consent and authorization is feasible and worthwhile. (Gutmann Koch.
2018). Finally, there is a need to significantly increase the training