Basic principles for human participation in research

Basic principles for human participation in research

Involving people in research: voluntary and safe participation

When human beings are involved in research, two basic principles are central from the point of view of ethics. First, the participation has to be voluntary. Nobody should be coerced or tricked into participating in research. It is good to remember that coercion can take different forms. In university settings, for example, it is important that students do not get the impression that they must participate in research of their instructors and supervisors. Similarly, in the social and health care settings it is important to clearly separate research participation from service provision.

Second, the participation of volunteers must be as safe as possible. Safety refers to both physical and mental safety; this means that researchers have a responsibility to protect the participants from all kinds of harm.

A well-planned and documented process for informed consent is a basic requirement for any researchers planning to involve human participants in their work. The informed consent process consists of the information provided to the potential participant and the confirmation of the informed consent.

For people to be able to give their informed consent, the information provided must be kept as non-technical and easy to understand as possible. The information can be provided in written and oral form. It is good to remember that the information serves the task of preparing the participant for the tasks at hand as well as possible.

Informed consent documents consist of an information letter and a confirmation form. In the information letter, a clear description of the project; reasons for the person recruited being contacted; short explanation how the contact has been established; what is expected of the participant; what risks and benefits are associated with the research; what data will be collected; how the data are collected; the project’s data protection policy; what rights research participants have; and names of contact persons will be provided.

In the confirmation form, the participants confirm with their signature, date and place, that they have read, or they have been read to, and understood all the information, that all their questions have been sufficiently answered, and that they give their free and voluntary consent to participating in the project. While informed consent documents should be easy to understand they must not cut corners as far as important information that forms the basis for decision making for the participant goes.

Privacy and data protection

Research ethics encompasses diverse concerns which are ethical, legal, political and social in nature. Privacy and data protection are relevant from the point of view of all of these concerns.

In involving human participants in research, care must be taken in collecting, using and handling all their data. Particular attention is required by collection of personal data and sensitive data. It is good to remember that personal data includes data that are often easily exchanged and transmitted, such as e-mail addresses and digital facial images.

Sensitive data include data revealing “racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, and the processing of data concerning health or sex life” (Article 10 of Regulation 45/2001; Article 8 of Directive 95/46/EC).

The processing of such information is in principle prohibited, except in specific circumstances. It is possible to process sensitive data for instance if the processing is necessary for the purpose of medical diagnosis, or with specific safeguards in the field of employment law, or with explicit consent of the data subject.

Data protection Act 2000

In Austria, the central legal instrument that regulates privacy and data protection is the Federal Act concerning the Protection of Personal Data which should be referred to as Datenschutzgesetz (DSG 2000). Particularly central for research purposes are Part 2: Use of Data; Part 3: Data Security; Part 5: Rights of the Data Subject; Part 9a: Video Surveillance.

In your research, you should take the legislation into account but also appreciate how to deal with people’s data in practice. As a researcher you are responsible for ensuring that the collection, handling, and storage of research data is done in such a way that the personal identity and the data of your research subjects stay secure where they should be, namely, on secured servers and behind lock and key out of reach of those who have no reason to access those data.

Anonymization and pseudonymization

The purpose of anonymization is to protect privacy or research participants. In this process data sets are encrypted or personally identifiable information are removed leaving the persons whom the data described anonymous. Not even you as researcher would identify through the data the person it relates to.

Some research data is easier to anonymize than others. Anonymous questionnaires are a case in point. Particularly in qualitative research projects, pseudonymization is often the best you can do. This means that participants are assigned individual codes or pseudonym names with which they are referred to throughout the research. In reporting about your work, especially when relying on methods of qualitative research, you must pay particular attention to avoiding unintentional contextual identification of participants (for example, describing a person in such detail by providing the name of a village, characterizations of the person’s tasks, that makes it easy to recognize them).

While much research requires anonymization and/or pseudonymization, the following would form exceptions:

  • Expert interviews: experts are usually interviewed due to their particular expert knowledge in a particular topic or area, resulting from responsibilities or obligations of their particular status. They present their own views in such interviews and are therefore credited as sources by mentioning their names. Always make sure that you and your expert interview partners are in agreement about the way of quoting them.
  • Participatory design: participatory design that involves future technology users is based on the idea that the process and end results of a project are shared and co-owned between researchers and participants. In such contexts, participants are sometimes referred to by their names to acknowledge co-ownership– provided this has been explicitly agreed upon with the participants.

It is important to deal carefully with the personal data that research participants volunteer for researchers’ use. The harm careless handling of data can cause is difficult to repair.