Safety, your rights, and complaints

Independent ethical review

Before any study can recruit a single person, it is reviewed by a Human Research Ethics Committee — an independent group including doctors, researchers, a lawyer, a layperson and someone with pastoral care experience, none of whom work for the company running the study. They assess whether the risks are justified, whether the information given to you is honest and understandable, and whether the reimbursement is appropriate rather than coercive.

Studies at this site are reviewed by Bellberry Limited or by the St Vincent's Hospital Melbourne Human Research Ethics Committee, depending on the study. The approving committee and its approval reference appear on every study page.

Informed consent

You will be given the Participant Information and Consent Form before your screening visit, in writing, to read in your own time. At the visit a doctor or research nurse goes through it with you and answers questions. You sign only when you are ready, and only before any study procedure begins.

If the study changes — for example, new safety information becomes available or the visit schedule is amended — you are informed and asked to provide consent again.

Withdrawal from a study

Withdrawal does not require an explanation. It does not affect your medical care elsewhere or your eligibility to take part in future studies at this site, and you are reimbursed for the visits you completed. You may be asked whether you are willing to attend a final safety assessment, which is conducted in your interest; you may decline.

Safety at the site

• A medically qualified investigator is on site during dosing and the observation period that follows.
• Emergency equipment, oxygen and trained staff are present in the unit.
• There is a documented procedure for transferring anyone who needs hospital care to The Alfred, approximately five minutes away by road.
• All adverse events reported are recorded and assessed, whether or not they appear related to the study medicine.
• Studies carry insurance arranged by the sponsor. The consent form sets out exactly what that covers.

Your personal information

Your identity is not disclosed to the sponsor; your study data is identified by a code. Records are held securely and handled in accordance with the Australian Privacy Principles. You have the right to request access to the information held about you. Further detail is set out in the privacy policy.

Raising a concern or complaint

Concerns are generally resolved most quickly by raising them with your study coordinator or the Principal Investigator in the first instance. You may also contact the site at hello@vitalisresearch.com.au, and your concern will be directed to the Medical Director.

If you would prefer not to raise the matter with the site, or you are not satisfied with the site's response, you may contact the approving Human Research Ethics Committee directly and independently. The committee for your study — Bellberry Limited or the St Vincent's Hospital Melbourne Human Research Ethics Committee — and its contact details are set out in the Participant Information and Consent Form you were given. The committee will consider the matter independently of the site. Raising a concern will not affect your treatment here.