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Consent forms

There are many things to think about when doing research on and with humans.
Two person looking at a document.

There are many things to think about when doing research on and with humans. The requirements will be based on your institution, funder, country, and possibly where you want to publish your data.

In general, most regulations are based on getting informed consent from the people you are studying. This means that a person has been informed about the content of a study and has made a voluntary choice to participate. The consent is normally given before a person takes part in a study.

Asking for informed consent is a legal obligation in several countries. In addition, it is also a good research ethics practice. Explaining how you collect and use data is important for your credibility as a researcher. It also builds trust in scientific research.

Consent can be gained by participants in a variety of ways: written or oral form, one-off or continuously, prospectively or retrospectively. In all cases, it is recommended to deliver the consent in the best way possible for that project. It is also essential to document the consent. That is why many researchers collect written consent that can easily be stored. This can be done on paper. Nowadays, it is also common to have electronic systems for storing the consent form. In many cases, the consent is collected as part of a questionnaire.

Sometimes it may not be feasible to collect written consent from participants in a study. For example, at the University of Oslo, we regularly organise MusicLab events. These are public concerts where we also collect data of the audience. Since we typically video record people from a distance, we have found that it is sufficient to clearly inform about the video recording. Then people can choose to stay outside of the recorded area. This can be seen as an example of a “silent consent”.

There are circumstances where informed consent is not applicable. For example, studying robotic motion does not need informed consent. Sometimes no form of consent can be obtained, like when the researcher collects the information from sources other than the persons themselves. These situations are exceptional and will need case-by-case review with advisement from the local ethical board, institution, or other appropriate legal entity.

If you are unsure what organizations, legislation, regulations, or guidelines apply, check out the International Compilation of Human Research Standards.

What should I inform about?

The informative portion of a consent form is meant to communicate details about the research project. General sections included are:

  • Purpose: The general purpose of the research
  • Involvement: What participation entails and the benefits of the research
  • Risks: Any risks associated with participation
  • Data Use: The planned usage of the data during the research, dissemination, storage, publishing and archiving of the data
  • Data Security: The procedures for safeguarding personal information, maintaining confidentiality and anonymizing data
  • Contact information: Names and contact information to the principal investigator of the study and possibly also the data protection officer at the institution.

Under some legislation, the process for withdrawing consent also needs to be given.

The consent portion of the document is an agreement to participate in the research. The consent needs to be freely given, informed, unambiguous, specific, documentable, and by a clear affirmative action that signifies agreement to the processing of personal data.

The best practice when crafting a consent for data sharing is to identify and explain the possible future uses of their data and offer the participant the option to consent in parts. Here are two examples of consent form strategies:

I agree to the non-anonymized audio recording of my interview being archived and disseminated for reuse yes/no
I agree to the anonymized transcript of my interview being archived and disseminated for reuse yes/no
I agree to any photographs of me taken during the interview being archived and disseminated for reuse yes/no
I have received and understood information about the project [insert project title] and have been given the opportunity to ask questions. I give consent: 

□ to participate in (insert method, e.g. an interview)
□ to participate in (insert other methods, e.g. an online survey) – if applicable
□ for my/my child’s teacher to give information about me/my child to this project (include the type of information)– if applicable
□ for my personal data to be processed outside the EU – if applicable
□ for information about me/myself to be published in a way that I can be recognized (describe in more detail)– if applicable
□ for my personal data to be stored after the end of the project for (insert purpose of storage e.g. follow-up studies) – if applicable

I give consent for my personal data to be processed until the end date of the project, approx. [insert date]

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(Signed by participant, date)

Reuse of data

Remember that if you want to reuse the data for a different purpose than what you originally intended, a new informed consent must be obtained.

References

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Motion Capture: The Art of Studying Human Activity

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