Participant Protection, Informed Consent, and Data Sharing

Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.  – Belmont Report, page 10

Recently, a researcher approached us at QDR to share her rich interview data. The proposed deposit was already anonymous (even the researcher only had participants’ first-name pseudonyms) and since the discussed topics were not particularly sensitive, neither the researcher nor our curation specialists saw any concerns for participants in publishing the data. As part of the project documentation, the depositor submitted her original Institutional Review Board (IRB) application, as QDR has been encouraging researchers to do. Reviewing that file, we found the following text in the consent form used:

Only [the researcher] will have access to the information on this computer; your recollections will be destroyed once the project has finished.

Without any ability to re-contact participants, this commitment made publication of the data impossible. The researcher had accepted the boilerplate language without fully realizing its impact on her ability to later share the data.

Burning the Evidence
Burning the Evidence” by Imagined Reality used under CC BY-NC-SA 2.0

Unfortunately, this is not an isolated case. Boilerplate language of this type is in wide circulation, and researchers might think making the promise to destroy research materials is the default, or even only, way to be responsible to the volunteers with whom they worked. Other data archives face similar issues on a regular basis.

Protecting human participants and respecting promises made to them is – to be quite clear – a crucial and indispensable part of research done properly. From its inception, QDR has been deeply invested in helping researchers to meet this ethical and legal obligation. Yet we often find that such language is included even where data are, as in the case above, hardly sensitive or where data could be safely and ethically shared using adequate protections such as thorough de-identification and/or restricted access.

An important reason researchers resort to such language is their understandable desire to see their proposal approved by the IRB as quickly and smoothly as possible. In our experience, however, IRBs rarely, if ever, suggest such sweeping language. Researchers often “self-censor” and include unnecessarily conservative language, to the detriment of data sharing and scientific progress.

We are therefore delighted to see that Cornell’s Institutional Review Board (see under Consent Templates > Social/Behavioral Template) now encourages researchers to include language in their informed consent script that explicitly allows for the sharing of research data:

Data Sharing

(We strongly recommend that you include this section in your consent, to inform participants that you may share de-identified data you collect from them. Certain sponsors now require researchers to make available their de-identified data to the research community, as do a growing number of journals in a variety of disciplines. If you choose not to include the following language and later wish to share de-identified data, you may not be able to do so without re-contacting participants to obtain consent.) 

De-identified data from this study may be shared with the research community at large to advance science and health. We will remove or code any personal information that could identify you before files are shared with other researchers to ensure that, by current scientific standards and known methods, no one will be able to identify you from the information we share. Despite these measures, we cannot guarantee anonymity of your personal data.

Do you know of other IRBs that suggest similar language? Did you have trouble getting your IRB to allow you to share data with others? Are you interested in preparing your own informed consent script and IRB application in a way that provides options for participants to understand your data sharing plans and choose whether to consent to them? We want to hear from you and are here to help: