Ethics advisor assigned to support researchers with ethical permit applications

In Sweden, research activities involving humans and animals are covered by the Ethics Review Act (2003:460), and the Animal Welfare Act (2018:1192). These research activities require ethical review/permit before the work can actually start.

In October 2021, the KTH Life Science Platform assigned Amena Archer  as an ethics advisor for two years. She is a senior scientist and lab manager at the Division of Cellular and Clinical Proteomics at the Department of Protein Science and works 25 per cent of her time with ethical permit guidance.

Amena Archer is intended to complement Fredrik Karlsson , Research Ethics Advisor at KTH Research Support Office, with specialised help concerning ethics permits for medical research.

“My task is to give information and answer questions about ethical permit applications. I help KTH researchers to determine which type of application they need, and I also guide them during the application process,” Amena Archer says.

More practical help for medical research

According to Peter Savolainen , KTH Life Science Platform Director, KTH is very strong in Life Science research but lacks practical help with ethical permits, which is often needed. 

“Ethical permits may seem a bit tricky, but we aim to lower the learning threshold for writing the permit applications. With our help, it should be easy! It is also possible that some scientists haven’t realised they need a permit for their projects, so we want to make sure that all KTH scientists have the correct information,” he says. 

The intention is also to raise awareness at KTH about the need for ethical permits and at the same time offer help so that it is easy to check whether a permit is needed or not, and if required, that it is easy to apply with support from the ethics advisor.

Positive reactions from researchers

Now Amena Archer has been on the job for four months. So far, the reactions have been very positive. Several researchers have contacted her with questions or to get help with their application. 

“From the feedback I got, it is clear that this new service provided by the Life Science Platform responds to a real need of KTH researchers. Indeed, some of the work carried out at KTH may require an ethical permit, and often the whole process appears complex because of the different steps and forms that need to be completed. My role is to provide guidance and support,” she says.

Her general advice to KTH researchers regarding ethics permits, is that it is important to take time to think and plan her/his research to identify a current or a future need of ethics permit. 

“And in case of doubt or question, do not hesitate to contact me!”

Evaluation after two years

In two years, the results of this ethical guidance service will be evaluated, to see if it was needed.

“Additionally, we will evaluate if a dedicated person for the task is also necessary in the future, or if the written instructions we are creating may be enough help. Based on this, possible future funding and the source of this funding may be discussed,” Peter Savolainen says.

Text: Helena Mayer

Human research studies and ethical permits

According to The Ethics Review Act (2003:460), the following is considered as research: scientific experimental or theoretical work, scientific studies through observation to acquire new knowledge, development of new methods on a scientific basis, and work intended for publication in a scientific journal.

In this case, an ethical review is required when it involves:

• the processing of sensitive personal data or personal data on violations of the law
• a physical intervention, on both the living and the dead humans,
• a method that aims to affect a person physically or mentally or that involves an obvious risk of harming the research subject/participant
• biological material from living or dead humans and is traceable.

It only applies to research to be carried out in Sweden. An ethical review is required even when not all but parts of the research are to be carried out in Sweden, but only for the Swedish parts. Thus, a Swedish ethical review is needed for research performed in Sweden, even if the research has a permit from another country.

It does not include work done as part of undergraduate or higher education (bachelor or master), as long as the work does not overlap with a "regular” research project and is not intended for publication in a scientific journal.

Clinical trials involving pharmaceutical products or medical devices and setting-up of a biobank are also covered by The Ethics Review Act (2003:460) as well as by other specific regulations. 

Source: Amena Archer

Animal research studies and ethical permits

According to The Animal Welfare Act (2018: 1192), animal experiments refer to the use of animals for:

• Scientific research
• Diagnosis
• Development and manufacture of drugs or chemicals products
• Teaching, when it involves killing the animal; surgery, injection or blood draw or any suffering or risk of suffering

Research activity involving animal experiments as defined by The Animal Welfare Act (2018: 1192), requires an ethical approval delivered by a regional animal experiment ethics committee, before the experiment begins. The ethical examination weighs the significance of the experiment against the animal's suffering. Based on the degree of suffering caused to the animal, the experiment is classified as: terminal, minor, moderate or considerable distress.

Source: Amena Archer

More information

Contact Amena Archer
Contact Peter Savolainen
Research Ethics at KTH