Informed Consent In Research

Informed consent is a basic requirement for clinical studies. It gives people a choice to participate in the study while understanding what the research entails. Generally, the consent form should contain a statement of the research study in question, the purposes of the research and the overall experiences along with the benefits that subjects may encounter. It should also contain a disclosure of any proper alternate plans of action or courses of treatment. Information about a study must be presented in a way that enables people to make decisions on whether they want to participate as a research subject or not. Despite the concept being simple there are several issues with the way current consent forms are written which fail to register key
fundamental information. Here are some of my thoughts on how a consent form can be organized or rewritten to provide adequate details for the subject for any given research.

One specific change that I would suggest for re-writing regulations would be to use more informed language that can be easily understood by everyone.
The purpose of the study should be in lay mans terms and should clearly state the reasons as to why it is considered. This along with legible fonts will be more appropriate especially when it comes to elderly and visually impaired population. One challenge of informed consent today is that there are false expectations of the study as well as experimental outcome and understanding of study procedures since consent forms are not very transparent (as cited in Nijhawan, Janodia, Muddukrishna, Bhat, Bairy, Udupa, Prashant). Many people sign the consent form without being aware of the details as the information is not very clear. For example, as described in The Oxford Textbook of Clinical Research Ethics, 75% of people who participated in an oncology research in Boston assumed that the purpose of the cancer study was to improve future cancer patient’s treatment (as cited in Emanuel, E. Chapter 59 p 646). There was clearly a complexity of understanding research purposes since they most likely were not clear about the
procedures.

If a potential subject is given information about the research in the form of writing, they should be able to understand and comprehend what they are reading. It is also important to keep in mind that majority of the subjects do not speak English, hence it is very important to use language that may be understandable to those subjects along with English speaking subjects. One must also keep in mind the demographic factors such as age and income status. Usually higher education levels and older age will have a better knowledge of the information that is presented. Hence the regulations would have to be re-worded in order to tailor to all sections of the population. Another thing I would consider is imposing stricter requirements regarding the information that is given. Usually most consent forms are incredibly long and have too much legal information which is not relevant for the study. This makes it difficult to understand (as cited in Emanuel E., Menikoff J. 1148). With forms that long, the most important information may often be buried or hard to find. They may also be written at too high of a reading level and frequently lack any vital information that is needed for informed decision making.

Most people may say that the reason for forms being this lengthy is to give as much information to the participants as possible, but the information can be too complex and may take a lot of time to be absorbed. Sometimes there may be too many details in the consent forms that often fail to focus on the risks associated with the study, which is more critical than some other information when it comes to participants. So I think that they should primarily include the important information that is relevant to a person’s decision making to participate in a study, and to organize the information to where it does not seem confusing. If these forms are more concise and direct with the participants, it will allow a shift in focus on them and will help protect them easier. By creating more transparency, this can not only lead to lesser confusion towards the research, but also generate more trust among the participants and the institution. This will also reduce the time spent on determining whether or not a study qualifies as free of any liabilities.

One another issue with consent forms of today is that most research participants do not realize that they are alienated with certain rights during research participation.
Some participants feel like they need to continue with their participation as they are not clearly explained the situation where they can withdraw their participation anytime. They could also be waiting for some form of verbal agreement allowing them to excuse themselves from the study. So another improvement I would consider is including a section making sure that participants know they are entitled to certain rights such as the freedom to withdraw their consent at any time if they choose not to participate in the
study.

One another key factor when writing an informed consent form is how the participants can perceive some negative effects due to their own religious beliefs. Sometimes providers of informed consent refuse information and referrals based on their own personal religious beliefs, which can run a high risk of violating this principle (as cited in National Women’s Law Center). People have the right to this kind of information regardless of whether there is some religious objection to the treatments or not. One could have a full understanding of the methods involved in the experiment, which will enable a person to judge whether they want to participate, but they may not consider how the methodology can come into conflict with one’s rules set by a participant’s religion. Knowing this information can help someone make more adequate decisions.

These above mentioned propositions show the improvements needed on the current informed consent regulations. The key is for the subject to understand what research they are getting into without violating their rights. If these suggestions are not taken into consideration it might put both the participants and investigators at risk.