November has no doubt been a month of interesting discussions and debates surrounding research and bioethics, as showcased recently at the 2015 PRIM&R Conference in Boston. (Editor’s note: for an in-depth look at our coverage from PRIM&R 2015, we welcome you to view our blog posts on PRIM&R Pre-Conference Highlights: From IRB 101 to Biobanking, PRIM&R AER15 Conference Highlights – Day 1: #mHealth, #SocialMedia, #BigData and PRIM&R AER15 Conference Highlights – Day 2: Working Together)

Following this conference, Veritas IRB was also present at a series of talks that further showcased very current research and bioethics stakeholders’ discussions, where there were certainly no shortages of topics to cover.  The 2015 Toronto Research Management Symposium (TRMS) was a dynamic series of presentations, held by the University Health Network . Just as PRIM&R had touched upon major industry topics, TRMS organizers did an excellent job at securing talented and expert speakers that extensively covered hot-button discussions in the industry, such as the continuing emergence of wearables and mobile health apps, Big Data, genomic sequencing and the impact that these all have on privacy and informed consent. As such, let us kick off our coverage with a statement made at TRMS by guest speaker, Patricia Kosseim: “Emerging technologies present exciting opportunities for researchers and also raise a whole new generation of privacy and ethical issues.” Let us discuss this further.

Privacy Expectations

The moment we use the Internet, our browsing activities are being tracked through cookies, web beacons and device data for different commercial purposes. Market research has developed different strategies to learn more about the consumption habits of Internet users by analyzing demographic information, online behaviour and conversations (i.e. through blogs, forums, video/image sharing and social media).

The right to gather and share this information is obtained through the “terms and conditions” Internet users are tacitly or blindly accepting in order to use the different platforms available online.

This finding leads to a fundamental question:

“Is there a right to be forgotten…to be delinked? … To be removed from Google?”

– Patricia Kosseim

Market research strategies such as online behavioural advertisement and social media listening of patient networks such as PatientsLikeMe, DailyStrength or KnowCancer are proving to be effective ways to recruit research participants or to conduct observational research to assess the efficacy of treatments. The question remains as to whether users of online patient networks are fully aware that the information they share may be observed for research purposes. As such, consent to use this information in a research context presents a challenge.

Consent challenges

A common theme among all the speakers was how challenging it is to obtain consent for the sharing of data arising from new technologies. Indeed, how does one go about obtaining meaningful consent when:

  • A certain research study involves the consultation of datasets of millions of social media or mobile health application users?
  • DNA samples will outlive their donors or the donors are already dead?
  • Impacts of technological advances on specimens and data are unforeseeable?

These questions were illustrated through presenting different scenarios of users downloading mobile health applications, researchers attempting to use legacy collections for stem cell research and private sector R&D organizations analyzing device user data to develop new products and services.

Meaningful consent’ and whatever it means – I think this is a challenge not only for big data research but all clinical research

– Leslie Ordal ‏@GenCounsNews, TRMS attendee

The issue of obtaining meaningful consent in research is currently the subject of intensive debate in the United States where the proposed amendment to the federal policy for the protection of research participants plans on limiting the content of informed consent forms to mandatory essential elements and the remainder of the information would be included as part of an appendix.

The proposed changes to the US federal policy highlights the question of how to build a robust informed consent form without ending with an overly extensive legal disclaimer, the latter being counterproductive to both research participants and researchers.

Rosario Isasi (@rosario_isasi), Research Associate at the Centre of Genomics and Policy at McGill University suggested that we could achieve meaningful consent through establishing “a longitudinal relationship between donor and researcher”. This approach would acknowledge that research participants have ongoing interests in the use of their tissues and data by developing mechanisms, which would foster continuous communication between researchers and participants. This relationship would propel scientific progress forward while ensuring that donors of tissues and data are respected when providing broad consent for future research [1]

We believe that mobile health applications may provide the solution to the above challenges as they could be used to establish and facilitate longitudinal relationships between research participants and researchers.

There is still work to be done

In conclusion, there seems to be an interesting dichotomy between research use of data and protecting participant privacy. Several interesting questions came out from the discussions at TRMS, such as the following: how can genomics and “mHealth” devices encourage active participation in health care? Where does the role of legislation come into play in the world of wearables and the aggregation of this data? These queries require further investigation and will no doubt be the centre of many future talks on research management. In the meantime, our goal to educate and extrapolate news from such sessions as the 2015 Toronto Research Management Symposium will continue as we aim to provide our readers with up-to-date news about our industry and open up more dialogue on these topics.

[1]

See for more information Justin Lowenthal, Scott Lipnick, Mahendra Rao, and Sara Chandros Hull, “Specimen Collection for Induced Pluripotent Stem Cell Research: Harmonizing the Approach to Informed Consent”, Stem Cells Transl Med. 2012 May; 1(5): 409–421

 

The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.