INSTITUTE OF MENTAL HEALTH ONLINE - Hospital Ethics Committee And Ethical Considerations

Research involving patients is in the interests of patients and society. It should proceed without unnecessary impediment. Safeguards are, however, necessary to protect the patient from suffering physical or emotional harm or breach of confidentiality in the course of research.

2.1	All research involving patients must be approved by the HEC.
2.2	The HEC will examine the overall design of proposed research and whether it is a worthwhile one.
2.3	The HEC and investigators have a duty to ensure that the risks inherent in the proposed research have been reduced to the minimum which is to necessary to achieve the objective.

3.1	Research which involves access to personal medical records should receive approval by the HEC.
3.2	Confidentiality must be ensured to avoid causing harm or distress to patients or their relatives. The list of patients' names should be confidential to the investigator and the hospital.

4.1	Patients who may be at greater risks from the proposed research procedures are to be excluded.
4.2	Where possible, patients should be invited to participate in research as volunteers in the same way as healthy individuals are invited to volunteer.
4.3	The investigator must make it clear that a patient is free to decline to participate without giving a reason. The patient participating should understand he is free to withdraw at any time.

5.1	Research involving a patient should only be carried out with the patients' consent. Exceptions are permitted in research based on some innocuous observations of behaviour, research based on anonymous specimen or on medical records and some research into emergencies.
5.2	The use of written consent is recommended in research projects associated with more than minimal risk or significant discomfort. A Patient Information Sheet should be given to patients when they are invited to participate.

6.1	Research which could equally well be done on adults should never be done on children.
6.2	Children should be consulted when the question of their participation in research arises.
6.3	The investigator should obtain the approval of a parent or guardian before any research procedure is contemplated on a child under the age of 18 years.

7.1	Research in mentally ill patients should be limited to that which is related to the mental illness.
7.2	Most patients with mental illness are competent to make up their own minds as to whether they wish to take part in research and to comprehend the implication of the research.
7.3	The HEC must be convinced that the inclusion of patients who are incompetent to give consent is acceptable and that it arises because the research is specifically directed to the condition of patients who might be incompetent.
7.4	Where the competence is in doubt due to psychosis, dementia or other causes and in all compulsorily detained patients, consent by both patients and relatives is necessary. When the competence is absent, the consent of the next of kin is required.

8.1	Research on mentally handicapped patients should be limited to that which is related to mental handicap.
8.2	Research in mentally handicapped patients is subjected to the usual constraints affecting all research patients.
8.3	The consent of the next of kin is necessary for mentally handicapped patients to participate in research.

9.1	Improved care should not be offered as an inducement to participants.
9.2	Payments to patients are generally undesirable and if given should not be for undergoing risks.
9.3	Any payments to be made to patients should be reviewed by the HEC.

10.1	The ordinary requirements of patients should not be neglected in the course of the involvement in research.
10.2	Where research activities are delegated by the investigator, the investigator should delegate only to individuals who have the necessary skills and experience.
10.3	The confidentiality of personal data must be preserved during the conduct of research.
10.4	The results of research should be published free from any interference by financial sponsors of the research.

11.1	The HEC will require the investigator in charge of approved research projects to submit a brief report of progress annually.
11.2	Investigators should send copies of any published reports to the HEC.