Four tips for consent forms
28/03/2017
Having recently looked at data protection in research data management (RDM) generally, and anonymisation more specifically, now let’s take a look at participant consent, as that’s another common area for questions.
Ethics support at Cranfield University can be found on the ethics intranet pages (internal link), including a sample consent form (docx). The sample form is likely to need editing for your project, but should be a useful starting point. It’s difficult to anticipate future use of research data, so here are four suggestions for your consent forms, to avoid some common mistakes that can present difficulties later on: two aspects to be sure to specify, and two not to specify.
- Specify the personal data being collected, as participants may not have the same understanding as you. For example, it is better for a form to say, “I understand that my name and contact details will not be shared with anyone outside the project team” than “I understand that personal data will not be shared outside the project team”. (And of course, do ensure that access to the storage area is restricted appropriately.)
- Specify the type of data collected, ideally allowing participants to make separate decisions about separate elements. For example, if there will be audio, transcripts, videos, and photographs (taken separately or extracted from video), a participant may be happy with transcripts being shared/published, but may not want video and photographs shared at all. If only some participants consent to publication of visual material, this may help sufficiently for use as example data in articles.
- Don’t specify the future re-use of anonymised data. Personal data can only be used for the precise purpose for which you collect it. However, if you can anonymise your data for sharing, such that it can no longer identify the individuals involved, this dataset can be used for new legitimate purposes. It is then important to use an open phrase such as “I understand that the de-identified survey responses will be made available for others to reuse”. This is preferable to a more restrictive line such as “I understand that the survey responses may be used in further research”. Whilst you may assume that the data would be used in further research, perhaps others may wish to use the data in teaching, or another purpose you haven’t considered. It is simpler and better value to make anonymised data available without detailed restrictions on reuse. It also simplifies the practicalities: when you put your data on a repository, such as CORD, you need to assign it a licence, and the standard options don’t specify types of re-use.
- Don’t specify where the anonymised outputs will be published. If you want to publish unanonymised data, you need to be very specific about this, with a line clearly stating the dataset in question and where it will be shared, e.g. “I am happy for the original [photographs/excerpts from transcripts/etc] to be published in academic journals and at academic conferences”. However, when it comes to the final dataset that has undergone true anonymisation, you can be more flexible, and must often plan to publish it as that is a requirement of many funders. Although you may have an idea early on of where you’ll publish your findings, this could change if you get the opportunity to disseminate your results elsewhere such as trade journals, conference proceedings, or the media. Use phrasing that allows you this flexibility, e.g. “I understand that the de-identified analysis data may also be published in a data repository, reports, and other media”. Avoid restrictive and unclear lines such as “I understand that the data may be published in academic journals”.
This is not an exhaustive list of aspects to consider in consent forms, but a few tips on areas where it is easy to be tripped up, as wording makes a big difference in consent and affects what you can do down the line. Whilst researchers and funders would like to aim for maximum visibility and value of the research outputs, their and our priority is, of course, for responsible research that informs participants fully and clearly, allowing informed decisions around data sharing and reuse.
For more discussion on consent in research, the UK Data Service pages have an excellent overview as well as more consent form templates.
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