Question

What is informed consent? what are the legal and ethical considerations to assessment processes?

Answer 1

Informed consent:

• Informed consent is an essential part for the design of research project that involving human subjects.Researchers who involve human subjects in their research should have ethical and legal consideration to secure the informed consent of the potential research subjects prior to initiation of the research.
• Prior to the beginning of the study the investigators should obtain the ethical committee approval for the written informed consent form.should provide all the information to the subjects or to their legal representatives.
• All the information should be understandable to the subject,legal representatives in both written and oral form, whenever possible.
• Subjects,legal representatives should be given and time to enquire about the details of the study and all questions answered to their satisfaction.
• The investigator,sponsor or staff should not influence a potential subject to participate or continue to participate in the study.Careful consideration should be given to ensure the freedom of consent obtained with a hierarchical structure such as medical,pharmacy,nursing students.

Prior to the subject's participation in the study the written informed consent form should be signed and dated by the:

• If the subject is incapable of giving an informed consent for example children,mental illness or disability.
• If the subject or legal representative is unable to read/write.
• An impartial witness should be present during the entire informed consent discussion.
• The investigator.

Essential information for prospective research on subjects:The investigator must provide:

• The aims and method of research
• Duration of subject participation
• Benefits that might be reasonable be expected as an outcome of research to the subject.
• An alternative procedure or course of treatment that might be as advantageous to the subject as the procedure.
• Right to prevent use of his/her biological samples at any time.
• The extend to which confidentiality of records could be safeguard and confidential.
• Free treatment for research related injury by investigator.
• Compensation of subject for death.
• Identify the research teams and contact persons with address and phone numbers.
• Risk of discovery of biologically sensitive information
• Publication.

Informed consent in non therapeutic study:

• The objective of the study cannot met by means of trial in subjects that who can give the informed consent.
• The foreseeable risks to the subjects are low.
• Ethics committee written approval is expressly sought on the inclusion of subjects