Plain language summaries of research

This is a plain language summary of an original research article. The views expressed are those of the author(s) and reviewer(s) at the time of publication.

About the research

When someone dies, they may be able to donate organs, cells or tissues to help other people through a transplant. This is a generous gift that can save or improve many lives. Donation after death also raises difficult ethical questions, because it happens at the same time as a person's care at the end of their life and their family's grief. Increasing numbers of researchers want to study donation and transplantation using donated organs or tissue so they can help more people and improve the results of treatment. Until now, there has been almost no ethical guidance for this kind of research. This article describes the first international guidelines created to fill that gap, known as the INTEGRITY Guidelines.

Why these guidelines were needed

There is already clear ethical guidance for donating organs after death for a transplant, and for research that involves living people. There has been very little guidance, though, for research that involves people who may donate around the end of their life, or people who receive a transplant from someone who has died. This is a complex area. Research may involve medical steps in a person's body before or after death, and donated materials or information may be studied years later. Without agreed standards, researchers and healthcare staff have found it hard to plan and carry out this research safely. This uncertainty can put people at risk of harm and can also hold back valuable research.

Increasing numbers of researchers want to study donation and transplantation using donated organs or tissue so they can help more people and improve the results of treatment. Donated tissues and organs that can't be used in transplantation can also be used in valuable research investigating a range of diseases or potential treatments for non-transplant diseases such as heart disease and diabetes.

How the guidelines were developed

Three international organisations led this work: the European Society for Organ Transplantation, the International Society for Organ Donation Professionals, and The Transplantation Society. Together they brought in a team of experts from many countries and backgrounds, including law, ethics, clinical care, and people with personal experience of transplantation. The team developed the guidelines over twelve months in four main stages:

• First, they reviewed the existing research and identified the main ethical concerns.
• Next, they wrote and revised draft guidelines, with feedback from a wider group of collaborators.
• Then they invited the public to comment.
• Finally, they reviewed the comments and agreed on a final version.

The team held workshops in Australia, the United Kingdom and Japan during this period. The three organisations formally approved the final guidelines in April 2026.

What people said during the public consultation

The team asked for public feedback through an online survey, which people could complete in eight languages. A total of 271 people from 48 countries gave complete responses. They came from many different backgrounds, and just over half were healthcare professionals. People could say how much they agreed with each proposed principle and add their own comments. Every proposed principle received agreement from at least three out of four people, and most received agreement from at least nine out of ten. This showed strong support for the approach taken.

What the guidelines cover

The guidelines are designed to help researchers, healthcare staff, people taking part in research, families making decisions, and the committees that review research. They apply to research involving adults and children, including people who are not able to make decisions for themselves. They cover a wide range of research, such as:

• Medical steps in the body of a person who has died.
• Collecting or using personal information about a donor.
• Studying donated organs, cells or tissues, including before a transplant or after it.
• Listening to the experiences of donor families, transplant recipients, or healthcare staff.
• Using information first collected for care or record-keeping in later research.

The eight core principles

The guidelines are built around eight core principles. In plain terms, they ask that:

1. Dignity is respected. Research should always treat people who have died, and their bodies, with respect and care. Donating for research should be valued as a meaningful gift, much like donating for a transplant.
2. Chances are fair. Everyone should have a fair opportunity to take part in research and to share in what it discovers. No group should be left out or unfairly singled out.
3. Everyone affected is considered. Researchers should think about all the people a study might affect, including the donor, their family, people waiting for a transplant, and healthcare staff.
4. Transplants come first. Research should not unfairly reduce the organs, cells and tissues available for transplants. If there is a clash, making sure people who need a transplant can receive one usually takes priority.
5. Privacy is protected. Personal information about donors, families, transplant recipients and staff should be kept private and confidential.
6. Research is open and honest. Research should be carried out openly so that people can trust it, results should be shared, and any concerns should be open to review.
7. People's choices are respected. People, or their families speaking for them, should be supported to make informed choices about taking part. A person's right to make their own decisions is called autonomy. When others decide on behalf of someone who cannot decide, they should follow what that person would have wanted.
8. The body is never bought or sold. The human body and its parts must never be traded. Donors and their families should neither lose nor gain money because of donation, although necessary costs can be covered.

What the guidelines do not do

These guidelines set out principles rather than step-by-step instructions. Each country will need to adapt them to fit its own laws and existing rules, and to use them alongside the usual guidance for research and for donation. The team also notes an important limit: members of the public, donor families and transplant recipients took part in smaller numbers than other groups. Future versions should include a wider range of voices.

What happens next

In 2024, the World Health Assembly called on member states to promote research and innovation to maximize the use and optimize the outcomes of transplantation of human cells, tissues and organs, as well as enable development of alternative therapies to those based on the clinical use of human cells, tissues and organs . These first international guidelines offer a strong starting point, but more work is needed to put them into practice, including training for those who use them. There are plans for further guidance on specific topics, such as consent, sharing of records, and the role of companies in research. In some countries change in culture may also help, so that research is seen as another option to offer donors and recipients, rather than something that competes with their care. Working together early can help include research in organ donation while keeping care for donors, their families and recipients at a very high standard.

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This plain language summary was created by the UKODTRN in collaboration with the UK Donor Family Network. 

The full guidelines will be published in Transplant International in Autumn 2026. 

The lead author of the guidelines has approved this summary.