Ethical Approvals

Research with human participants requires that you think carefully and critically about ethical matters. On this site you find COBE Lab's guiding ethical principles and how they are implemented in our research procedures.  By reading this page you will understand why ethics certification and an approved ethics checklist are required. You will also find information about the function and operation of COBE Lab's Human Subjects Committee.

1. Ethical principles

Research in COBE Lab is guided by the ethical principles regarding research involving human participants as set out in the Declaration of Helsinki and the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Researchers will minimize harm and maximize benefits pertaining to their research by implementing such ethical research procedures.

Please note that if a professional external company is used to recruit and select participants, it is the duty of the researcher to confirm that they follow sound ethical principles in their work.

1. Respect for the participant

  • Participants are to be treated with respect.
  • The selection of participants must be fair and special care must be taken not to involve vulnerable population only for the purpose of convenience. 

2. Informed consent

  • Participants must give informed consent before research can begin.
  • Consent is to be voluntary, specific and informed. Consent is to be obtained in writing.
  • Prior to giving consent, sufficient information regarding the purpose of the research and methods used is to be communicated to participants.
  • If research involves aspects that may influence willingness to participate, then this is communicated to participants prior to written consent as well.
  • When the research participants are children, information must be provided on a level that is appropriate for a child’s understanding, and informed consent must be sought from parents. 

3. Provide appropriate information

  • Withholding information for participants is not acceptable, unless it is essential for research purposes.
  • When withholding information is essential to the research purpose, additional information is provided to the participants as soon as possible. Care should be taken that additional information does not conflict with the information in the informed consent form.
  • With regard to the COBE Lab subject pool, COBE Lab has an explicit no deception policy, which means that deception may not be used in any studies for which participants will be recruited from the pool. Studies involving uses of deception may however gain access to other COBE Lab resources. It is required that any deception that is an integral feature of the design and conduct of an experiment is explained to participants as early as is feasible. This is preferably at the conclusion of their participation, but no later than at the conclusion of the data collection.
  • Participants are to be informed before the research is undertaken about their right to withdraw from the research, even without giving a reason, at any time during the data gathering. It should be clear whether and how withdrawal affects incentives for participating in the study, such as gift cards or monetary payments. For example, state whether payments are only made to those completing an entire session. In surveys, one should make sure the respondents are aware that completing the survey is voluntary. If carried out online, this is done with an informed consent screen.

4. Privacy and data protection measures

  • Participants must give approval for their data to be used for research purposes.
  • The collected data are anonymous and confidential. Exceptions from data handling privacy described here require separate approval from Datatilsynet, where necessary.
  • As a rule-of-thumb, the research data are collected anonymously, except when it is essential for the purpose of the research to be collected otherwise or practically impossible.
  • When personal or identifiable data are collected, they are stored separately from research data. Before running analyses, research data should be coded and made anonymous, and any links between personal and research data should be destroyed. COBE has set up its own data management system to among other things decouple personal or identifiable data from research data.
  • All personal or identifiable data collected during research are confidential, unless it has been agreed otherwise beforehand. In case confidentiality cannot be guaranteed for any reason, participants are to be informed in advance and they give specific consent to release their information.

For further information please read the section titled 'Human Subjects Committee' below.

2. Research Ethics Checklist and consent form

It is mandatory to submit a research ethics checklist for your project in COBE Lab. The checklist is not an application for formal ethics approval for your study. We have developed the checklist to support researchers to carefully and critically think about ethical and data protection issues pertaining to their research. Two or more members of the Lab’s Human Subjects Committee will review the Checklist.

After undergoing review, you will be contacted by Lab management with the comments from the Human Subjects Committee. Issues will be discussed between the three parties—namely the research team, the Human Subjects Committee and lab management.

If the issues cannot be resolved, the research project under review may not take place at Cognition and Behavior Lab. Please note that lab management and the Scientific Advisory Board make the final decision about whether a study can be conducted at the Lab.

Find the research ethics checklist and consent form template in our procedure guide

3. Ethics certification

To perform research at Cognition and Behavior Lab all researchers and research assistants are required to have ethics certification. We ask individuals involved in data collection / data processing to complete an ethics course.

It has been a standard to complete the NIH ethics course entitled “Protecting Human Research Participants". The certificate is no longer available free of charge. We instead recommend the Protecting Human Research Participants (PHRP) online course. The cost of the course is 39.99$ (Note: when buying access to the course, leave the box "Participate in CME?" unchecked. Otherwise you will be charged an additional 25$ for the course.)

Once completed please send the certificate to cobelab@au.dk.

4. COBE Lab's Human Subjects Committee - When and Why?

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:
Human Subjects Committee
Procedure Guide

5. Regional ethics approval (Health Research) - When and Why?

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) 

6. Aarhus University's Research Ethics Committee - When and Why?

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

7. Responsible conduct of research at Aarhus University

Aarhus University’s aspiration is for all of the university’s research activities to have the highest possible quality and credibility, with respect for freedom of research and a research climate of lively, open and critical academic discussion within and across different fields of research and research traditions. This is why Aarhus University has a policy for the responsible conduct of research and subscribes to the Danish Code of Conduct for Research Integrity, which is based on a number of international declarations and principles for research integrity and responsible research practice. 

You can download the policy here and view AU's responsible research site here.

8. Human Subjects Committee - Terms of reference

1. Purpose of the COBE Lab Human Subjects Committee 

Cognition and Behavior Lab (COBE Lab) is a research environment for social science, humanities, and interdisciplinary research. The wide range of disciplines and fields within social science and humanities use a variety of methodological approaches, including surveys, questionnaires, focus groups, interviews, direct observations, physiological measurements, and behavioural experiments. The common denominator is that this research is undertaken on human subjects. This requires special attention to ethical principles. Research ethics guidelines are necessary to guarantee respect for human dignity, scientific integrity, societal value, and the rights and interests of the research participants.

The primary purpose of the COBE Lab Human Subjects Committee (hereafter, COBE HSC) is to ensure the protection of research participants involved in studies at COBE, enabling the safe participation of human subjects in studies conducted at COBE Lab.

COBE HSC serves two functions in this regard, a primary and a secondary.

  • The primary purpose of the COBE HSC is to evaluate whether studies follow the ethical guidelines of the Lab. The focus of this evaluation is whether the interests of the participants are sufficiently protected in the study. Studies that are found to not follow the guidelines of the lab will not be granted access to lab resources. Thus the COBE HSC’s primary function is to regulate access to COBE lab space, resources, and human participants.
  • The secondary purpose of the COBE HSC is to provide advice and raise awareness of research ethical issues among researchers.

2. The Ethical Principles on which COBE HSC Operate

COBE HSC reaches decisions about whether access to the COBE Lab can be granted on the basis of the ethical principles set out in "The Declaration of Helsinki" and "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." It is expected that the research in question will be carried out in accordance with other international, national and university-level codes of conduct. Implementing the following procedures will usually ensure the necessary minimization of harm.

2.1 Respect for the participants

  • Participants are to be treated with respect.
  • Special care must be taken to protect vulnerable participants.
  • Proper care must be taken to minimize risks associated with research. Research must be designed so that human participants face no greater risk of harm than would normally be encountered in everyday life. In particular, when designing their studies, associated researchers are expected to evaluate their designs in light of the kinds of risk which might occur during the course of social science and humanities research generally. Such risks might involve, but are not limited to: consumption of drugs or food substances; risks to expectations of privacy in the form of location tracking or internet usage; collection of sensitive or personally identifying data; any kind of social or physical stress or discomfort. Studies evaluated to involve such risks will be referred to the Danish National Committee on Biomedical Research Ethics.

 

2.2 Informed consent

  • Participants must give informed consent before data collection can begin.
  • Consent is to be voluntary, specific and informed. Consent is to be obtained in writing or through a computer interface.
  • Prior to giving consent, information regarding the purpose of the research and methods used is to be communicated orally and in writing to participants.
  • When the research participants are children, information must be provided on a level that is appropriate for a child’s understanding, and informed consent must be sought from parents.

 

2.3 Provide appropriate information

  • As a general principle, misleading participants is not acceptable, unless effective non-deceptive alternative procedures are not feasible.
  • In many research designs withholding information is essential to the research purpose. In such cases, additional information is provided to the participants as soon as possible. Care should be taken that additional information does not conflict with the information in the informed consent form.
  • With regard to the COBE Lab subject pool, COBE Lab has an explicit no deception policy, which means that deception may not be used in any studies for which participants will be recruited from the pool. Studies involving uses of deception may however gain access to other COBE Lab resources. It is required that any deception that is an integral feature of the design and conduct of an experiment is explained to participants as early as is feasible. This is preferably at the conclusion of their participation, but no later than at the conclusion of the data collection.
  • Participants are to be informed before the research is undertaken that they have the right to withdraw from the research without giving a reason at any time during the study. After the data collection, research participants have the right to have their data removed from the data set (if this is possible, e.g., if the data have not been anonymized), without losing their right to any compensation already granted.

 

2.4 Privacy and data protection measures

  • Participants must, as part of the informed consent, give approval for their data to be used for research purposes.
  • The collected data are confidential. The research data are collected anonymously except when it is essential for the purpose of the research to be collected otherwise, or when anonymous data collection creates significant practical problems. In these cases, the data are to be anonymized within reasonable time, as permitted by the research design.
  • When personal or identifiable data are collected, they are stored separately from research data after the experiment is completed. In particular, before running analyses, research data should be coded and made anonymous. Any links between personal and research data should be destroyed within reasonable time, as soon as the research design permits. COBE has set up its own data management system that allows researchers, among other things, to decouple personal or identifiable data from research data.
  • All personal or identifiable data collected during research are confidential, unless it has been agreed otherwise beforehand. In case there are reasons why confidentiality cannot be guaranteed, participants are to be informed in advance and asked to give specific consent to release their information.
  • Personal data refers to any information relating to an identified or identifiable natural person (as defined in The Act on Processing of Personal Data). Notice that even if a participant is not identified by CPR-number, phone number, email address etc., a participant may still be identifiable. This is possible for example through the collection of sociodemographic data such as age, gender, place of residence and education. Such data are therefore also considered personal data, and must be treated accordingly. This means that researchers should ensure that their published results have cell sizes such that individual participants are not identifiable. In particular, proper anonymization needs to be ensured before making a data set available to third parties (e.g., as a downloadable data set on a journal web page or researchers’ web pages).

3. Seeking and Obtaining Approval and Feedback from the COBE HSC

All researchers must familiarize themselves with the guidelines of the COBE Lab. It is also mandatory for all researchers involved in a study at COBE Lab, including research assistants, to undertake ethical training and forward a certificate of completion of this training to lab management.

For each specific study, researchers are required to apply for access to the COBE Lab by completing the Research Ethics Checklist.

Normally, the researchers will receive feedback from COBE HSC within a week. The feedback is divided into two sections, to reflect the two different aims of COBE HSC. One section will specify any needed changes that are required for the study to be carried out at COBE Lab. Another section will be advisory and specify additional comments that the researchers can take into consideration at their own discretion, given the standards and practices of their sub-discipline.

The feedback concludes by describing any next steps in the evaluation process. In general, four types of responses can be given:

  • 1) access is granted
  • 2) access is granted conditional on the implementation of the described changes but no further communication is needed with the COBE HSC other than a brief declaration that these changes will be implemented
  • 3) access is granted conditional on the implementation of the described changes but further communication about those changes are needed with COBE HSC.
  • 4) access cannot be granted (unless major revisions are undertaken to the study design, in which case a new checklist is required).

Responses 3 and 4 may contain an invitation to a meeting between the researchers and the chair of the COBE HSC and, potentially, other members of COBE HSC or other persons that may have expertise in relation to the case considered. In the case that a consensus between the researchers and COBE HSC cannot be reached, the researchers can appeal to the Scientific Advisory Board, who will make a final decision.


4. The Organization of COBE HSC

COBE HSC is composed of seven members: one chair, one member of COBE Lab management and five ordinary members. The chair constitutes the link between the HSC, on the one hand, and the COBE Lab Scientific Advisory Board and COBE Lab management, on the other hand.

The chair of COBE HSC, with participation of the ordinary members, ensures that new members of COBE HSC receive an adequate introduction to the processes and procedures of the HSC. The COBE Lab Scientific Advisory Board have the responsibility to ensure that members of the HSC are sufficiently qualified through their experience and expertise and, if required, receive adequate training in ethical evaluation and approval.

To ensure the protection and qualifications of the HSC, all members of the HSC should have obtained a PhD degree, be employed in an academic position at Aarhus University, be familiar with laboratory research involving human subjects and have documented knowledge about research ethics (e.g., from the NIH ethics course). To ensure that diverse disciplinary views are represented in the HSC, members should be recruited from different departments. The chair of the HSC will will always be a permanently employed researcher at the associate professor level or above.

Feedback is prepared collectively by the members of the COBE HSC. The standard procedure is that each study is evaluated by at least two members of the COBE HSC. COBE Lab management ensure that the workload is evenly distributed among the members. Generally, membership of the COBE HSC is for a two-year period with two members of the HSC being changed each year.


5. What COBE HSC is Not: The Potential Need for Further Permissions

COBE HSC only serves functions internally to the COBE Lab and, hence, does not cover permissions required by legal entities, journals, or similar. Under Danish law, COBE Lab cannot take on any legal responsibilities by granting access to the lab and, hence, legal responsibility remains with the researcher.

COBE Lab emphasizes that it is the researchers' own responsibility to comply with Danish law, including consulting the Danish National Committee on Biomedical Research Ethics, if necessary. According to the Danish National Committee on Biomedical Research Ethics – “research projects in Denmark involving human beings or any kind of human tissue, cells etc., need permission from a regional ethics committee”. Research within the social sciences usually involves minimal intervention, i.e., is non-invasive, and therefore does not require approval by a regional ethics committee. However, it is the responsibility of the researchers to ascertain that such full clearance is not needed, e.g., by way of a query (“forespørgsel”) to the regional ethics committee. 

All studies run at COBE Lab that contain personal data need to be registered with the office for data protection at Aarhus University. In these cases, the process will be mediated by the COBE Lab management. If a commercial provider is used to recruit and select subjects, it is the duty of the researcher to confirm that the provider adheres to sound ethical principles, e.g., as set out by the ICC/ESOMAR in the Code on Market and Social Research.