When a person living with cancer chooses to participate in a clinical trial or to share their health information, it’s important they are treated with respect and that their data is handled ethically.
Respect for patients is at the heart of consent and ethics in health research. It ensures that people are fully informed about the purpose of the trial, who owns the data and how their data will be collected, de-identified, used and managed.
The impact of poor ethical treatment
Unethical research can have significantly negative impacts. Dr Kandy White at Australian Clinical Trialsresearch studies performed to test new treatments, tests or procedures and evaluate their effectiveness on various diseases cites the 40-year Tuskegee study on the natural progression of syphilis in African-American males as an example of this. The subjects did not know they had syphilis, were not told they were part of a trial and were not treated for the disease despite penicillin being available at the time.
The harms from this included passing on the disease to their partners, some of their children being born with congenital syphilis, and loss of trust in the public health system.
Giving informed consent
Consent for clinical trials in Australia is governed by the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Human Research. This states that the guiding principles for consent and ethics are respect for the person and voluntary participation.
The Office of the Australian Information Commissioner (OAIC) also lists certain key standards for collecting health information from patients:
- Practitioners can collect health information with the patient’s consent when reasonably necessary.
- The health information must only be collected legally and by a fair process. This means it must be given voluntarily and without deception, coercion or intimidation.
- The patient must be notified of certain information when their health data is collected, such as the purpose of the collection and how the information will be handled.
Following these guidelines ensures the patient can make informed decisions about whether to provide their information for specific purposes.
Prof Nik Zeps, Director of Research for Epworth HealthCare, points out that consent is not always a “one-time” thing but sometimes needs to be ongoing, as clinical trials can run for many years. In these instances, participants have a right to withdraw consent at any point.
Prof Zeps also says that communication regarding consent should be tailored to the individual, to allow for differing backgrounds and education levels, as well as in respect of how much-written information the person requests or is willing to read.
The last point emphasises how important it is for trial participants to know as much as possible to their own satisfaction before consenting. This may include whether or not the trial results will be published – as there have been instances where people participated in a trial believing they were contributing to medical knowledge, only to find out later that the results were never published.
Where consent is not required
There are certain situations where consent isn’t required for research purposes. An example is where there is a legal requirement to report notifiable diseases to a health authority – such as reporting cancer cases to the state central cancer registry.
Other situations include where there is a serious threat to public safety, in a medical emergency, and where the patient is a child at-risk.
Health information and privacy protection
When a person’s health information is collected or shared, they may have concerns about privacy and confidentiality.
Health and medical data are considered to be “sensitive” in nature. When used in health research it must be de-identified – meaning patients cannot be personally identified from it.
The OAIC also says privacy notices for collecting health information must include the purposes of the collection, whether it is required by law and any consequences for not collecting it. It must also cover how the information will be handled and how complaints can be made.
Balancing consent and privacy
When it comes to health research, some say that where participation is restricted to giving consent it could skew study results. This is because there is evidence that people from certain demographic groups are more likely to grant consent in comparison to others.
On the other hand, where health data must be collected by law, such as in the case of reporting notifiable diseases, it means a broad collection of participants get included in the database. This is beneficial for population studies.
But whatever the approach, it’s crucial that all data is managed ethically and in line with privacy and legal requirements.
Authored by Dr Amanda Ruth