how remaining pathology samples can be used for medical research

A doctor’s visit often ends with you leaving with a pathology request form in hand. The application form will soon include filling a sample container, drawing blood, and maybe even taking a tissue biopsy.

Your sample then goes to a clinical pathology laboratory for analysis, as directed by your doctor. All of this is intended to get to the bottom of the health problem you are experiencing.

But what happens to the remaining sample after all the tests have been performed? In most cases, the leftover samples end up in a waste bin for incineration. However, sometimes they can be reused for other purposes, including research.

Who can apply my remaining samples?

The samples we are talking about here include the range of samples that clinical laboratories receive in the normal course of their research work. These include blood and its various components (including plasma and serum), urine, stools, joint and spinal fluids, swabs (e.g. from the nose or wound), and biopsy tissue samples.

Clinical pathology laboratories often apply leftover samples to practice or validate testing methods and aid ensure test accuracy. This type of apply is an vital part quality assurance processes laboratories must perform and are not considered research.

The remaining samples can also be used by researchers from various agencies such as universities, research institutes or private companies.

They can apply leftover samples for research activities, such as trying out fresh ideas or conducting small-scale studies (more on this later). Companies developing fresh or improved medical diagnostic tests can also apply leftover samples to evaluate the effectiveness of their test, generating the data needed regulatory approval.

What about informed consent?

If you have ever participated in a medical research project, such as a clinical trial, you may be familiar with the concept of informed consent. During this process, you have the opportunity to learn about the study and what your participation involves before you decide to participate.

So you may be surprised to learn that using leftover samples for research purposes without your consent is allowed in most parts of Australia elsewhere. However, this is only allowed under certain conditions.

In Australia National Health and Medical Research Council (NHMRC) offers guidance on the apply of residual pathology samples.

One of the conditions for using leftover samples for research without consent is that they have been received and stored by an accredited pathology service. This helps ensure that samples have been collected safely and correctly, for a valid clinical reason, and that their further apply does not result in any additional burden or risk of harm to the person who provided the sample.

Another condition is anonymity: the remaining samples must be de-identified and cannot be easily re-identified. This means they can only be used in research if the identity of the donor is not required.

The decision to authorize the apply of residual pathology samples in a specific research project is made by an independent person Human Research Ethics Committee including consumers and independent experts. The Commission assesses the project and considers the risks and potential benefits before authorizing an exemption from the requirement for informed consent.

Similar frameworks exist in United States, United Kingdom, India and elsewhere.

What tests can be performed on the remaining samples?

You may wonder how useful leftover samples are, especially when they are unrelated to the person and their medical history. However, these samples can still be a valuable source of information, especially for early-stage “exploratory” research.

Research using leftover samples has helped us understand antibiotic resistance in the bacteria that causes stomach ulcers, Helicobacter pylori. This helped us understand how malaria parasites, Plasmodium falciparumthey damage red blood cells.

Leftover samples also aid researchers identify better, less invasive methods detect chronic diseases such as pulmonary fibrosis. They enable scientists to make an assessment variant prevalence hemoglobin, which may interfere with commonly used diagnostic blood tests.

All this can be done without your consent. The types of tests researchers perform on leftover samples will not in any way harm the person from whom they were taken. However, using what would otherwise be discarded allows scientists to test a fresh method or treatment and avoid burdening people with having to provide fresh samples specifically for research.

When considering ethical issues, it can be argued that not using these samples to obtain maximum benefit is in fact unethical because their potential is wasted. Using leftover samples also minimizes the costs of preliminary testing, which is often taxpayer-funded.

Policy inconsistencies

Despite NHMRC guidance, some states and territories do their own legislation and guidelines that differ in significant ways. For example in New South Walesonly pathology services can apply leftover samples for certain types of internal work. In all other cases, consent must be obtained.

Ethical standards and their application in research are not inert and evolve over time. As medical research progresses, the framework governing the apply of leftover samples also changes. However, it would be ideal to develop a nationally coherent approach to this issue.

It is vital to strike a balance between ensuring ethical integrity and supporting scientific discovery. Through ongoing dialogue and oversight, remaining pathology samples will continue to play a critical role in driving innovation and progress in healthcare, while respecting individual privacy and rights.