Research ethics committees – what and why?

With the addition of an official Research Ethics Committee (IRB) at Aarhus University, there are now several places to get ethics approval for projects. But which one do you need? All of them or none? Read our guide to get a quick overview of the available options.

2019.04.04 | Cognition and Behavior Lab

Please note: This article is intended to offer a basic understanding of how the different committees operate and under which circumstances researchers need approval from one or the other. Researchers will need to seek additional information to determine for themselves what committees they need to submit their projects to for review. Links to more information is provided throughout.

At the moment, there are at least three committees where researchers at Aarhus University can get ethics approval: 

1)   The Human Subjects Committee (Cognition and Behavior Lab, AU BSS)
2)   The Research Ethics Committee (Aarhus University)
3)   The Central Jutland Regional Committee on Health Research Ethics, or the National Committee on Health Research Ethics (both are part of the Danish committee system as defined by the Committee Act

Each have a specific purpose and jurisdiction, detailed below. Currently, researchers should never need approval from all three committees. 

The Central Jutland Regional Committee on Health Research Ethics 

In short: You need approval from this committee if the law requires it.

The Committee Act is a piece of Danish legislation that exists to ensure that health research projects in Denmark are conducted according to a proper ethical standard. The committee system is made up of a committee at the national level (the National Committee on Health Research Ethics, or in Danish, Den Nationale Videnskabsetiske Komité), as well as several regional committees. For researchers based in the Aarhus area, the legal body governing health research projects is the Central Jutland Regional Committee on Health Research Ethics (De Videnskabsetiske Komitéer for Region Midtjylland). Under normal circumstances, this is the committee that researchers at Aarhus University will submit their projects to for review. 

According to the National Committee on Health Research Ethics (NCHRE), all health research projects in Denmark must be notified to a research ethics committee. Quoting from their website, the duty to notify comprises, among others, “trials involving live-born human individuals, human gametes intended for fertilisation, fertilised human eggs, embryos and foetuses, tissue, cells and genetic material from humans, foetuses etc. or deceased persons” (“What to notify?", 03.04.2019).  Studies involving clinical trials of medicinal products for human use and clinical testing of medical devices are also covered by the duty to notify. 

Research within social sciences often involves minimal intervention, which in many cases means that they don’t need to be submitted to the Central Jutland Regional Committee on Health Research Ethics (RCHRE) for a full review. For example, studies that use questionnaires and interviews, but where no human biological material is involved or collected, do not need to seek approval (“What to notify?”, 03.04.2019). However, if there is doubt about whether a research project qualifies as a “health” project, then the project should be submitted to the committee. Based on the Committee Act, an assessment will be made of whether the project should be subject to a full committee review. Researchers will receive a formal reply with an explanation of the decision including references to the relevant legal clauses.  

For more information about which projects should be submitted for assessment or full review, as well as examples for clarification and links to relevant legislation, go to “What to notify?
Other helpful links:
Website for the National Committee on Health Research Ethics 
The Committee Act (Danish only) 

Aarhus University’s Research Ethics Committee

In short: You need approval from this committee if it is necessary for you to have ethics approval, yet your project is not eligible to be reviewed by the regional or national committee under the rules of the Committee Act.

Quoting from the website for Aarhus University’s Research Ethics Committee (AUREC):
Research projects are increasingly subject to requirements for ethical approval by the relevant university department. This requirement stems mainly from the EU’s framework programmes and international journals, and relates specifically to projects that collect empirical data and are not covered by the Committee Act on Regional Committees for Health Research Ethics [sic], which only applies to research projects in the field of health sciences. […] The Committee’s responsibility is to ensure a consistent and responsible framework for project approval and make it easier for AU researchers to obtain grants and publish.” (”Ethical approval of research”, 03.04.2019) 

In other words: The committee exists for the benefit of those researcher who, due to requirements from e.g. the EU, journals, etc., need ethics approval, but are not eligible to be reviewed by the RCHRE or NCHRE under the Committee Act. Therefore, researchers will not currently need approval from both committees: An approval by a committee under the Committee Act should make an approval from AUREC redundant. 

AUREC acts as an Institutional Review Board in that it grants institutionalised approval of projects. Researchers who receive approval from AUREC may write in their publications: “the project was approved by the Institutional Review Board at Aarhus University, approval #: [approval number]”. However, “The Committee is not responsible for ensuring that individual projects comply with research ethics or data protection regulation. Responsibility for this lies with the researcher/research group in question.” (”Guidelines for the AU Research Ethics Committee”, 04.04.2019) 

AUREC can advise that research projects which do not comply with AU’s regulation is stopped, but it is not authorised to terminate research projects. 

For more information and a guide to the application process as well as the evaluation criteria, see following links:
Ethical approval of research projects 
Guidelines for the AU Research Ethics Committee

Cognition and Behavior Lab’s Human Subjects Committee

In short: You need approval from this committee if you want access to resources in COBE Lab.

The purpose of Cognition and Behavior Lab’s Human Subjects Committee (COBE HSC) is to ensure that the research that takes place in COBE Lab follows the Lab’s ethics policy. This is to protect the participants as well as the Lab’s reputation. The COBE HSC will also comment on any issues with data protection that they find concerning, and can recommend or require that AU’s Technology Transfer Office (TTO) is involved to ensure that personal data is properly handled. Finally, the HSC will at times comment on the study design as a form of peer feedback. Only ethics and data concerns can block a researcher’s access to COBE Lab – not concerns about the research design. 

The purpose of the HSC is only to allow or deny access to COBE’s resources based on COBE’s ethics policy. Whether researchers need approval from COBE HSC therefore depends entirely on whether the researcher wants access to COBE Lab’s resources (labs, equipment, and participant pool). Approval from COBE HSC is needed in that case; an approval from either AUREC or RCHRE will not grant researchers access to COBE Lab. This is due to the specific requirements of COBE Lab’s ethics policy, for example the Lab’s no-deception policy, or the requirement to pay participants a set average amount of money for their time. 

Conversely, approval from COBE HSC is not useful outside of the Lab. Therefore, if researchers face external requirements to obtain ethics approval for a project, an approval from COBE HSC will not be useful; an approval from AUREC or RCHRE is likely needed instead (depending on the specific case). 

For more information about the Lab’s ethics policy, the purpose of the HSC, and the approval procedure, follow the links below:
Ethics
Human Subjects Committee 
Procedure guide 

In conclusion

Due to the many differences between the available committees, there is not currently a “one size fits all” solution for getting a single ethics approval which is valid everywhere. Neither are there plans to consolidate the different ethics committees into one entity. 

It is highly recommended that researchers stay informed about the requirements for ethics approval. This is especially the case in relation to AUREC and the committees under the Danish Committee Act, as an ethics approval from either of these committees have further reach and implications than the ethics approval that is available from Cognition and Behavior Lab.

For those researchers who want access to COBE Lab’s resources, information can be found on the Lab’s website. You can also contact lab management directly for advice about the application procedure.

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