Informed consent and internet-based research in epidemiology

Guidelines are needed for obtaining and storing informed consent in internet-based research

The internet has become an easily accessible resource for conducting epidemiological research, but there are currently no national guidelines for researchers or human research ethics committees which are specific to ethical considerations in internet-based research in Australia.

Epidemiological studies are increasingly using the internet as a tool for recruitment and data collection. This increased use is due to the practical and methodological advantages that the internet offers researchers over traditional means, such as lower long term costs, easier access to a large number of respondents over a wide geographical area, results in real time and improved data integrity.1,2

Through our experience with an online epidemiological study (www.forgottencancers.com.au), we have identified a need for clarification and guidance regarding the collection and storage of informed consent obtained online. We conducted a scoping review of academic and grey literature on the topic of online consent in health research and found that these issues are only beginning to be articulated. Discourse has focused on participants’ perspectives of online consent, the internet as a site for research, and online privacy and confidentiality concerns.1,3,4 Discussion of the ethical and methodological implications of online consent in terms of documentation, regulation and compliance is sparse.

There is little discussion of the implications of collecting online consent (eg, a date and time stamp, recorded by the action of ticking an “I agree” box) for meeting ethics, regulatory and compliance requirements. Physical documentation, stored in physical archives or scanned and stored electronically, allows researchers to easily show that informed consent for study participation has been obtained. Conversely, the online consent process typically produces a simple date record in a database and it is unclear how this information should be stored and whether it will be acceptable for auditing purposes.

In our review, we found just two articles that referred to the issue of documenting online consent;5,6 neither of which explored the ethical or practical implications of using electronic methods of storage versus paper consent forms. Grady5 identified that the documentation and storage of electronic consent is challenged by the difficulty in verifying the identity of the authorising person, but did not discuss how electronic consent might be documented and stored in practice. Cummings and Rowbotham6 refer to the United States Food and Drug Administration guidelines on the use of electronic informed consent to conclude that participants may “sign” an electronic consent form using passwords or biometrics. They recommend that participants receive a copy of the completed consent form, which may be provided electronically.

Epidemiological studies, particularly those that link to external datasets, collect biological samples or wish to access specimens or tissue for research purposes, face additional complications. They must consider the data access requirements of data custodians, including providing proof of participant consent through relevant documentation. In informal conversations with Australian epidemiologists conducting internet-based research, we found a variety of practices, including obtaining consent solely online, obtaining hard-copy consent before allowing online access or requiring hard-copy consent for specific aspects of the study (eg, collection of genetic material). These practices may result in unnecessary work and associated costs (eg, through the generation of digitally generated consent forms), a greater burden on participants (if asked to consent online and in hard copy) and, where more than one method of collecting consent is used, potentially greater confusion for everyone involved. There is also has the possibility of approved research being restricted if the stored consent is not viewed as sufficient by institutions that researchers subsequently seek to obtain information from.

The outcome of the National Health and Medical Research Council’s public consultation on ethical conduct in human research is due to be released in early 2019. The draft chapter, published in November 2016, contains a new section on internet-derived data, but this section does not address the concerns we raise above.7

We therefore recommend incorporating guidelines for methods of obtaining and storing informed consent in internet-based epidemiological research into the revision of Section 3 of the National Statement.7 These guidelines should:

• outline appropriate means for collecting online consent (eg, tiered approach, acceptable signatures) to meet ethical principles;

• define requirements for regulatory and compliance purposes (eg, what kind of documentation is considered sufficient to demonstrate participant consent); and

• provide clarity for research collecting different types of data (eg, epidemiological, clinical, genomic).

Based on current practice and practicalities, our position is that collecting a date and time stamp associated with the action of ticking an “I agree” box is sufficient evidence of study consent for ethical and governance compliance purposes. However, it needs to be recognised as such in the appropriate guidelines.