A blog from the Centre for Research Ethics & Bioethics (CRB)

Tag: registry research

How do we find out if drugs are safe for groups excluded from clinical trials?

Drug development requires that the drug is tested on patients in clinical trials. Not only the drug’s effectiveness is tested on the patients, but also its safety. Does the drug have serious side effects and what dosage is safe? Thanks to such clinical research, approved drugs can be provided with safety information, which enables doctors and patients to make informed decisions about drug treatment.

However, there are vulnerable groups that are often excluded from clinical studies, such as pregnant and breastfeeding women. But this protection of a vulnerable group can make the group extra vulnerable when deciding on drug treatment. If there is no evidence, it is not known whether the medicine the woman needs risks harming her, the fetus or the child being breastfed. It is also not known what dosage should be recommended. Perhaps the woman herself refrains from taking a medicine she needs, or receives advice from the doctor to refrain from it. Not because one knows that the medicine poses risks for the group, but because one does not know.

Are there other ways to obtain evidence on medicine safety for pregnant and breastfeeding women, besides clinical studies? Yes, there are, because pregnant and breastfeeding women must of course often use medication. Several registers already contain data from women who use medicines during pregnancy. In addition, pregnant and breastfeeding women using medicines may be engaged in additional data collection activities. Thus, there is already data as well as additional opportunities to collect data, without involving the group in clinical studies.

Josepine Fernow describes in Uppsala Reports such an attempt to compile existing data and expand the possibilities of collecting new data: the European project IMI ConcePTION. This project is developing several different paths towards better future safety information about drug treatment during pregnancy and breastfeeding. One challenge is to develop a technical infrastructure where data collected in different registers and in different formats are harmonized so that they can be collected and handled in standardized ways. Another challenge is to enable pregnant women to easily report relevant data about their medication use, for example via a mobile application. The project also tries to produce new data on breastfeeding and medicine use. For example, milk is collected and analyzed from breastfeeding women who use various medicines, in order to understand and predict how these medicines are transferred to the breast milk and in what concentration. Two of these breastfeeding studies are underway in Sweden. They are coordinated by CRB and we will write about them on this blog.

ConcePTION is also developing a knowledge bank that will be available online from the end of 2024, which will make the data and knowledge generated by the project useful. There are thus several avenues for research along which one can generate evidence for better safety information about various medicines for pregnant and breastfeeding women, without involving the group in clinical studies.

Read Josepine Fernow’s description of the project here: Making medicines safer for pregnant and breastfeeding women. There you will also find several links to the project and to the project’s publications.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

This post in Swedish

Part of international collaborations

Dynamic consent: broad and specific at the same time

The challenge of finding an appropriate way to handle informed consent to biobank research is big and has often been discussed here on the Ethics Blog. Personal data and biological samples are collected and saved for a long time to be used in future research, for example, on how genes and the environment interact in various diseases. The informed consent to research is for natural reasons broad, because when collecting data and samples it is not yet possible to specify which future research studies the material will be used in.

An unusually clear and concise article on biobank research presents a committed approach to the possible ethical challenges regarding broad consent. The initial broad consent to research is combined with clearly specified strong governance and oversight mechanisms. The approach is characterized also by continuous communication with the research participants, through which they receive updated information that could not be given at the time of the original consent. This enables participants to stay specifically informed and make autonomous choices about their research participation through time.

The model is called dynamic consent. This form of consent can be viewed as broad and specific at the same time. The article describes experiences from a long-term biobank study in South Tyrol in Italy, the CHRIS study, where dynamic consent is implemented since 2011. The model is now used to initiate the first follow-up phase, where participants are contacted for further sampling and data collection in new studies.

The article on dynamic consent in the CHRIS study is written by Roberta Biasiotto, Peter P. Pramstaller and Deborah Mascalzoni. In addition to describing their experiences of dynamic consent, they also respond to common objections to the model, for example, that participants would be burdened by constant requests for consent or that participants would have an unreasonable influence over research.

I would like to emphasize once again the clarity of the article, which shows great integrity and courage. The authors do not hide behind a facade of technical terminology and jargon, so that one must belong to a certain academic discipline to understand. They write broadly and specifically at the same time, I am inclined to say! This inspires confidence and indicates how sincerely one has approached the ethical challenges of involving and communicating with research participants in the CHRIS study.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Biasiotto, Roberta; Pramstaller, Peter P.; Mascalzoni, Deborah. 2021. The dynamic consent of the Cooperative Health Research in South Tyrol (CHRIS) study: broad aim within specific oversight and communication. Part of BIOLAW JOURNAL-RIVISTA DI BIODIRITTO, pp. 277-287. http://dx.doi.org/10.15168/2284-4503-786

This post in Swedish

We care about communication

Wanted: two researchers to join our team

The Centre for Research Ethics and Bioethics (CRB) is currently recruiting two researchers. We are looking for creative persons who like multi-disciplinary collaboration and are fluent in English.

1. Researcher in health economics (UFV-PA 2012/2684): We are looking for a person with a doctoral degree in health economics with documented skills in Discrete Choice Experiments.

2. Researcher in ethics/biobank/registry research regulations (UFV-PA 2012/2683): We are looking for a person with a doctoral degree in ethics or law, or someone with a doctoral degree in medicine or life sciences with an interest in ethical issues.

Both positions are 2-year appointments, with possible prolongation.

Application deadline: November 29, 2012.

(Job descriptions and information about the applications in the links above.)

Pär Segerdahl

We transgress disciplinary borders - the Ethics Blog