Clinical Trials - Are you Undertaking Research in your Practice?

The medical indemnity experts at Tego can help ensure you are covered when you participate in important clinical trials or research within your general practice. We understand many health practitioners are always trying to learn more as well as be a part of the newest and most innovative medical research.

The Royal College of General Practitioners has recently amended the Standards for general practices, specifically around indemnifying research in practice.

The Standards previously stated, “you must have your own insurance that covers the research.”

They have now been updated to be more explicit stating “the practice’s GP’s each need to ensure that their individual medical indemnity insurance covers their research activities or purchase top-up or separate insurance cover that provides the appropriate level of indemnity required to participate in research.”

Medical Indemnity

Responsibility of conducting health research

Being involved in the design, organisation, conduct or reporting of health research involving humans brings particular responsibilities for doctors. These responsibilities, drawn from the NHMRC guidelines, include:

  • According to participants the respect and protection that is due to them.
  • Acting with honesty and integrity.
  • Ensuring that any protocol for human research has been approved by a human research ethics committee, in accordance with the National statement on ethical conduct in human research.
  • Disclosing the sources and amounts of funding for research to the human research ethics committee.
  • Disclosing any potential or actual conflicts of interest to the human research ethics committee.
  • Ensuring that human participation is voluntary and based on an adequate understanding of sufficient information about the purpose, methods, demands, risks and potential benefits of the research.
  • Ensuring that any dependent relationship between doctors and their patients is taken into account in the recruitment of patients as research participants.
  • Seeking advice when research involves children or adults who are not able to give informed consent, to ensure that there are appropriate safeguards in place. This includes ensuring that a person empowered to make decisions on the patient’s behalf has given informed consent, or that there is other lawful authority to proceed.
  • Adhering to the approved research protocol.
  • Monitoring the progress of the research and promptly reporting adverse events or unexpected outcomes.
  • Respecting the entitlement of research participants to withdraw from any research at any time and without giving reasons.
  • Adhering to the guidelines regarding publication of findings, authorship and peer review.
  • Reporting possible fraud or misconduct in research as required under the Australian code for the responsible conduct of research.

Tego is here to keep your practice safe

Before carrying out any clinical trials or research, you should speak with your insurance advisor or medical indemnity insurer to confirm your medical indemnity insurance policy and medical practice policy cover you for participation in NHMRC approved clinical trials or research.

As medical indemnity insurance providers in Australia, Tego Insurance will cover your practice with medical indemnity insurance, medical malpractice insurance, doctors indemnity insurance, medical practice insurance, gp medical indemnity insurance, and more. If you are a health practitioner with Tego, your medical indemnity insurance comes with 24/7 medico-legal advice and support to guide you through risks and ethics as it relates to medical research,

This publication is general in nature and is not comprehensive or constitutes legal or medical advice. You should seek legal, medical or other professional advice before relying on any content, and practice proper clinical decision making with regard to individual circumstances. Persons implementing any recommendations contained in this publication must exercise their own independent skill or judgment or seek appropriate professional advice relevant to their own particular practice. Compliance with any recommendations will not in any way guarantee discharge of the duty of care owed to patients and others coming into contact with the health professional or practice. Tego Insurance Pty Ltd is not responsible to you or anyone else for any loss su­ffered in connection with the use of this information.