Question

What are some issues around an informed consent and how can they be resolved? Thank for you help.

Answer 1

Informed consent is the document with legal value, which is signed with date by the participants, with clearly informing the purpose, benefits, risks and other areas of the procedure or clinical study and voluntary providing consent for the same.

Issues of Informed consent:

• Language issues: The client must be able to read and understand the document and must sign the document with clear information. If the client can't understand the language in which the document is written, then it is an issue faced by the researcher or the provider of a care. The issue can be solved by using a translator to make the client understand and the document can be translated to the client's language and can get consent.
• The perceptions of the client: Usually people don't want to participate in research study. They may feel that being part of a new experiment will cause harm to them. Convincing and getting consent signed is very difficult in such cases. The issue can be managed by counselling the clients and meeting the people who have participated in similar studies and sharing their experiences.
• Getting consent from susceptible groups: People who have learning disability etc, it is very difficult to make them understand what the study is about, how they have to participate etc.. This issue can be solved with the help of a special educator to some extent.
• Children: When children are study participants, usually consent is gained from the parents. If the child is above 7 yrs, consent from child is also mandatory. The issue arises when the parent give consent but child disagrees to participate in the study. The children don't want to learn, but they love to know things. The study participation can be made interesting to them, so that their curiosity arises and they agree to participate.
• Religious impact: Some procedures or study methodology are not accepted by the client's beliefs, in that case the client may not agree to participate. The researcher has to make sure the client's religious beliefs are not conflicted by the study, and should not force the client to participate.