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Positive feedback on ethics review application support

A woman in a lab analysing DNA.
The ethics support is evaluated during spring, but it is already clear that it meets a real need of KTH researchers. Photo: Istock
Published Feb 13, 2023

Since October 2021, the ethics review application advisor Amena Archer has supported 35 cases where KTH researchers needed help. She has also arranged ethics support webinars and provided information for an internal support page. The two-year interim service, based on funding from the KTH Life Science Platform, is now being evaluated.

A woman with dark hair and a blue blouse.
Amena Archer. Photo: Lise-Lotte Vedin

”To this day, I have helped researchers from the KTH schools CBH, EECS, SCI, and ABE. The most common questions are to determine whether a research project requires an ethical review/permit. Also, we have had several requests for support to complete ethical applications,” Amena Archer , Ethics Advisor, KTH Life Science Platform , says.

Amena Archer, also a senior scientist at CBH, is complementing Fredrik Karlsson , Research Ethics Advisor at the Research Support Office, with specialised ethics review application support for medical research

On her 25 per cent appointment, Amena Archer has worked with the service for 1.5 years. During this time, she has taken care of 35 cases, including answering questions, providing support for ethical review/permit applications and contacting different agencies and institutions for issues related to ethical permits and regulations.

”We got really positive feedback from the people who got support, particularly from those we could help complete an ethical review/permit for the Swedish Ethical Review Authority, Etikprövningsmyndigheten. We do not write the application for the researchers. However, we try to provide personalised support and accompany them in the application process,” Amena Archer says.

Application process guidance

Her general advice to KTH researchers is to visit the webpage  and contact her  to determine if their research requires an ethical review/permit.

”I can guide the researchers along the application process from preparation to submission. The application is less complex than it seems. Still, it is essential to have a clear project plan with defined objectives and a careful reflection on the human subject regarding integrity, safety, consent, and data protection.”

Support service evaluation in spring

In spring, the support service will be evaluated to see how it could be improved and to decide if a dedicated person for the task is necessary for the future or if the webpage with written instructions may be enough help.

”But we already believe this assignment meets a real need of KTH researchers and that it should be maintained.”

Text: Helena Mayer

Examples of support cases

European plasma samples analysed in Sweden

A project focused on analysing human plasma samples for a large European consortium, including several research groups. The samples are collected by different European members of the consortium who have their own ethical permits according to local regulations. The samples are pseudonymised, protected by a key-code system, and will then be sent to Sweden for analysis. The part of the analysis performed in Sweden requires an ethical permit, which includes determining how long the samples will be kept after their analysis/the end of the project, the generation of sensitive data and how this data will be stored and protected appropriately.

Global human tissue samples used in Sweden

A project focused on genomic-based technology development for disease diagnostic and prevention. The technology developed by a KTH research group requires using different types of human tissue samples that are pseudonymised, supplied by several collaborators around the world, who all have ethical permits according to local regulations. The development of the new technology performed in Sweden requires an ethical permit since it will use human tissue samples that can be traceable and will generate sensitive data that will require proper storage and protection.
 

Swedish biobank human samples in a US agency grant application

A grant application at a US agency for genomic-based technology development. The grant agency requires a valid local ethical permit when applying because it involves human samples. The project uses samples from a Swedish biobank, but after discussion with the biobank, it is unclear whether the samples are anonymised (untraceable) or pseudonymised (potentially traceable). Because of this grey zone, an application has been submitted to the Swedish Ethical Review Authority. The project might not meet the criteria for ethical approval, but it could get an advisory statement. Both procedures require the exact same application.
 

Resources

Contact

Aména Jocelyne Archer
Aména Jocelyne Archer
Ethics Advisor, KTH Life Science Platform

Webpage

Support for ethics review application

Recorded information seminars