What is the role of ethics committee in medical research?
For the purpose of the Rule 122DD, an Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing …
What are the functions of ethical committee?
Ethics committees review research proposals involving human participants and their data to ensure that they agree with local and international ethical guidelines. They also monitor studies once they begin and—if necessary—may take part in follow-up actions after the end of the research.
Which bodies are involved in ethical review in South Africa?
South Africa has a centralized registration process for ethics committees (ECs). (Note: ECs are referred to as health research ethics committees (HRECs) in South Africa). The National Health Research Ethics Council (NHREC) is a statutory body established under the NHA.
What does a human research ethics committee do?
Human Research Ethics Committees (HRECs) review research proposals involving human participants to ensure that they are ethically acceptable. In Australia, HRECs review research proposals that involve human participants to ensure that they meet ethical standards and guidelines. …
What are the research ethics responsibilities of researchers?
Responsibilities for ethical research
- Gain informed consent from participants.
- Protect the interests of vulnerable groups.
- Assure the anonymity of participants, where appropriate.
- Assure the confidentiality of information, where appropriate.
- Respect the privacy of participants (and avoid undue intrusion)
What are the responsibilities of a research ethics board?
A research ethics board (REB) is an independent committee made up of medical and non-medical members, such as physicians, statisticians, and community advocates. It ensures that a clinical trial is ethical and that the rights of study participants are protected.
What are the functions of ethics in research?
Research ethics are moral principles that guide researchers to conduct and report research without deception or intention to harm the participants of the study or members of the society as a whole, whether knowingly or unknowingly.
What are the functions of ethics?
At its simplest, ethics is a system of moral principles. They affect how people make decisions and lead their lives. Ethics is concerned with what is good for individuals and society and is also described as moral philosophy.
What is the role of an ethics committee Institutional Review Board?
The primary function or role of the IRB is to safeguard human subjects by training researchers in research ethics and best practices and reviewing research proposals. In reviewing a research protocol the IRB must balance the research’s risk to the human subjects with the benefits to society.
What are GCP guidelines?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.
What is a research ethics committee?
A research ethics committee is a group of people appointed to review research proposals to assess formally if the research is ethical. This means the research must conform to recognised ethical standards, which includes respecting the dignity, rights, safety and well-being of the people who take part.
How do ethics committees make decisions?
Members of the Ethics Committee will gather information from the patient or patient record, family members and those involved in the care of the patient, clarify potential ethical concerns, conduct a confidential discussion of the case with committee members and provide recommendations to address the ethical dilemma.
What are health research ethics committees in South Africa?
(Note: ECs are referred to as health research ethics committees (HRECs) in South Africa). The National Health Research Ethics Council (NHREC) is a statutory body established under the NHA. NHREC gives direction on ethical issues relating to health and develops guidelines for the conduct of research involving humans and animals.
Is the South African Medical Research Council registered?
The South African Medical Research Council Human Research Ethics Committee is registered by the National Health Research Ethics Council.. Registration number: REC-130312-011 valid until 30 November 2023
What does the Ethics Office of the samrc do?
The Ethics Office in the SAMRC serves as Secretariat to the Human Research Ethics Committee (HREC) and the Ethics Committee for Research on Animals (ECRA). All intramural and extramural research conducted by the SAMRC on humans has to be reviewed by the Ethics Committee.
When was the HSRC research ethics committee established?
A HSRC Research Ethics Committee (REC) was established on 27 November 2002. The HSRC REC is registered with the South African National Health Research Ethics Council of the SA National Department of Health (NHREC No 290808-015) and also has US OHRP Federal-wide Assurance (FWA) accreditation (FWA 00006347, IRB No. 00003962).