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Posted on Sep 16, 2012 in Letters | 0 comments

Ethical Considerations Related to Mobile Technology Use in Medical Research


A/Prof Melissa Parker MD1,2
1Pediatric Critical Care Medicine and Pediatric Emergency Medicine, McMaster Children’s Hospital,2Pediatric Emergency Medicine, The Hospital for Sick Children, Adjunct Clinical Assistant Professor of Pediatrics, University of Toronto in Medicine.
Corresponding Author: parkermj@mcmaster.ca
Journal MTM 1:3:50-52, 2012
DOI:10.7309/jmtm.23


Mobile technology has become increasingly prevalent in the workplace.  Smart phones, tablets, and other forms of personal digital assistant have particular appeal for professionals seeking tools to enhance productivity.  Research in particular requires the capacity to collect and process data in an efficient and cost effective manner.  Investigators are increasingly turning to mobile devices for solutions as programs and data handling capabilities become more sophisticated.  With these developments, however, arises the need to contemplate and address ethical considerations relevant to mobile technology use in the research context.

There are many reports describing use of mobile devices as part of the research process.  Examples include remote field data collection1-51. Onono MA, Carraher N, Cohen RC, et al. Use of personal digital assistants for data collection in a multi-site AIDS stigma study in rural south Nyanza, Kenya. Afr Health Sci2011;11(3):464-73.
2. Kelly GC, Hii J, Batarii W, Donald W, et al. Modern geographical reconnaissance of target populations in malaria elimination zones. Malar J 2010;9:289.
3. Yu P, de Courten M, Pan E, et al. The development and evaluation of a PDA-based method for public health surveillance data collection in developing countries. Int J Med Inform 2009;78(8):532-42.
4. Byass P, Hounton S, Ouedraogo M, et al. Direct data capture using hand-held computers in rural Burkina Faso: experiences, benefits and lessons learnt.Trop Med Int Health 2008;13 Suppl 1:25-30.
5. Acosta JA, Hatzigeorgiou C, Smith LS. Developing a trauma registry in a forward deployed military hospital: Preliminary report. J Trauma 2006;61(2):256-60.
, observational data collection6-96. Hlady CS, Severson MA, Segre AM, et al. A mobile handheld computing application for recording hand hygiene observations.Infect Control Hosp Epidemiol2010;31(9):975-7.
7. Tejani N, Dresselhaus TR, Weinger MB. Development of a hand-held computer platform for real-time behavioral assessment of physicians and nurses.J Biomed Inform2010;43(1):75-80.
8. Guryan J, Jacob B, Klopfer E, et al. Using technology to explore social networks and mechanisms underlying peer effects in classrooms. Dev Psychol 2008;44(2):355-64.
9. Asaro PV. Synchronized time-motion study in the emergency department using a handheld computer application. Stud Health Technol Inform 2004;107(Pt 1):701-5.
, survey administration,44. Byass P, Hounton S, Ouedraogo M, et al. Direct data capture using hand-held computers in rural Burkina Faso: experiences, benefits and lessons learnt.Trop Med Int Health 2008;13 Suppl 1:25-30.,10,1110. Vanden Eng JL, Wolkon A, Frolov AS, et al. Use of handheld computers with global positioning systems for probability sampling and data entry in household surveys. Am J Trop Med Hyg2007;77(2):393-9.
11. McBride O, Morgan K, McGee H. Recruitment using mobile telephones in an Irish general population sexual health survey: challenges and practical solutions. BMC Med Res Methodol 2012;12:45.
and patient data diaries12-15Add a Tooltip Text. Mobile devices also have the potential to improve the feasibility of conducting research in poor and underserviced areas of the world where this is much needed1616. Lang T. Advancing global health research through digital technology and sharing data. Science 2011;331(6018):714-7.
. In addition to facilitating data collection and/or the administration of study instruments, mobile technology can be used to enhance the methodological quality of a study.17,1817. Parker M. Use of a tablet to enhance standardization procedures in a randomized controlled trial. JMTM 2012;1(1):24-6.
18. Parker M, Manan A, Duffett M. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort. Trials 2012;13:90.

While investigators may be excited by the potential for mobile technology to improve the research process, Research Ethics Boards (REBs) and Institutional Review Boards (IRBs) may be hesitant.   The role of the REB/IRB is to ensure that research is conducted in an ethical manner19-2119. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects: Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; the 35th WMA General Assembly, Venice, Italy, October 1983; the 41st WMA General Assembly, Hong Kong, September 1989; the 48th WMA General Assembly, Somerset West, South Africa, October 1996; the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000, the 53rd WMA General Assembly, Washington, DC, USA, October 2002; the 55th WMA General Assembly Tokyo, Japah, October 2004; the 59th WMA General Assembly, Seoul, Korea, October 2008. Ferney-Voltaire, France: World Medical Association1964.
20. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. In: Department of Health E, and Welfare., editor. Washington, D.C.: Government Printing Office; 1979.
21. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2 ed: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada; 2011.
and in accordance with institutional policies and jurisdictional laws.  Research involving human subjects must adhere to the basic ethical principles, including respect for persons, beneficence, and justice.2020. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. In: Department of Health E, and Welfare., editor. Washington, D.C.: Government Printing Office; 1979.  Of particular relevance to research protocols incorporating mobile technology are considerations related to participant privacy, confidentiality and data handling.

While the considerations related to data handling may be obvious, there are additional aspects of mobile device use in research that may raise ethical questions.   When a minimal risk survey study of health care providers was recently proposed to the REB of the author’s institution, concerns were raised about the impact of mobile device use on the voluntariness of study participation.  The proposed protocol involved use of a tablet-based information and consent form followed by a tablet-based survey.  In this case, the scanned information and consent form bearing the stamp of approval of the REB could be displayed on the tablet, and an associated signature box permitted eligible participants to sign the tablet-based consent form with their finger if they elected to participate.  The tablet was to be offered to potential participants by a Research Assistant knowledgeable about the study and available to answer any questions prior to handling the tablet and/or prior to signing the consent.  From a process perspective, the proposed sequence of events was very similar to that which occurs with use of a paper-based consent, where the medium would simply be a tablet rather than paper.   The advantages of use of a tablet based information and consent process are that this eliminates the costs related to printing information and consent forms, the need for the research assistant to carry these, and the need to securely store signed consent forms for the required period.

The REB chair rejected our proposed use of a tablet-based information and consent process on the basis that this did not provide eligible participants sufficient time to consider whether they wished to participate in the study or not.  The ethical principle of concern related to the voluntariness of participation due to the immediacy of tablet based survey.  Instead, the REB mandated use of a paper-based information and consent sheet in conjunction with the tablet-based survey, although participants were still recruited through direct approach by a Research Assistant.  Interestingly, the same REB deemed acceptable the recruitment of survey participants via email, where the email inviting study participation contained a hyperlink to a Survey Monkey version of the survey and an electronic version of the information and consent sheet was simply provided as an email attachment which participants were under no obligated to review.  Additionally, no signature was required from participants completing the Survey Monkey version of the survey as the REB interpreted the decision to click on the survey hyperlink as a positive indication of consent.  The REB apparently considered the email invitation/web-based survey hyperlink process more autonomous, given that eligible subjects could read the email invitation in privacy and return to it at a later time if they wished.

Some of the considerations relating to data privacy, confidentiality, and security have been previously reported.1818. Parker M, Manan A, Duffett M. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort. Trials 2012;13:90.
,2222. Perera C. Principles of Security for the use of Mobile Technology in Medicine. JMTM 2012:5-7.
  In Canada, some institutional REBs are showing increasing disapproval of traditionally accepted survey programs (Survey Monkey) that involve web-based data collection and storage due to data privacy, confidentiality, and security concerns.  Investigators planning to submit for ethics review a protocol involving the use of mobile technology should expect their REB to scrutinize procedures related to data collection, storage and security, as well as any potential threat to the privacy and confidentiality of participants.  One way to avoid potential delays is to contact the REB directly regarding a study proposal prior to submitting a formal application.  In the example provided, all correspondence was handled via email following an advance inquiry regarding the acceptability of the proposed process.  REBs are typically open to such communication and this can save investigators time by identifying potential concerns early.

Mobile technology is an exciting development for investigators that allows for many creative research applications.  While the technology or proposed use may be unfamiliar to an REB, the same basic ethical principals in judging the appropriateness of its use will be applied.  Up front inquiries can ensure clarity and help avoid delays in obtaining protocol approval.

References

1. Onono MA, Carraher N, Cohen RC, et al. Use of personal digital assistants for data collection in a multi-site AIDS stigma study in rural south Nyanza, Kenya. Afr Health Sci2011;11(3):464-73.

2. Kelly GC, Hii J, Batarii W, Donald W, et al. Modern geographical reconnaissance of target populations in malaria elimination zones. Malar J 2010;9:289. 

3. Yu P, de Courten M, Pan E, et al. The development and evaluation of a PDA-based method for public health surveillance data collection in developing countries. Int J Med Inform 2009;78(8):532-42. 

4. Byass P, Hounton S, Ouedraogo M, et al. Direct data capture using hand-held computers in rural Burkina Faso: experiences, benefits and lessons learnt.Trop Med Int Health 2008;13 Suppl 1:25-30. 

5. Acosta JA, Hatzigeorgiou C, Smith LS. Developing a trauma registry in a forward deployed military hospital: Preliminary report. J Trauma 2006;61(2):256-60. 

6. Hlady CS, Severson MA, Segre AM, et al. A mobile handheld computing application for recording hand hygiene observations.Infect Control Hosp Epidemiol2010;31(9):975-7. 

7. Tejani N, Dresselhaus TR, Weinger MB. Development of a hand-held computer platform for real-time behavioral assessment of physicians and nurses.J Biomed Inform2010;43(1):75-80. 

8. Guryan J, Jacob B, Klopfer E, et al. Using technology to explore social networks and mechanisms underlying peer effects in classrooms. Dev Psychol 2008;44(2):355-64. 

9. Asaro PV. Synchronized time-motion study in the emergency department using a handheld computer application. Stud Health Technol Inform 2004;107(Pt 1):701-5.

10. Vanden Eng JL, Wolkon A, Frolov AS, et al. Use of handheld computers with global positioning systems for probability sampling and data entry in household surveys. Am J Trop Med Hyg2007;77(2):393-9.

11. McBride O, Morgan K, McGee H. Recruitment using mobile telephones in an Irish general population sexual health survey: challenges and practical solutions. BMC Med Res Methodol 2012;12:45. 

12. Luckmann R, Vidal A. Design of a handheld electronic pain, treatment and activity diary. J Biomed Inform2010;43(5 Suppl):S32-6. 

13. Bray P, Bundy AC, Ryan MM, North KN. Feasibility of a computerized method to measure quality of “everyday” life in children with neuromuscular disorders. Phys Occup Ther Pediatr2010;30(1):43-53. 

14. Langan SM, Williams HC. The use of electronic diaries in dermatology research. Dermatology 2009;218(4):344-6. 

15. Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med 2007;8 Suppl 3:S101-9. 

16. Lang T. Advancing global health research through digital technology and sharing data. Science 2011;331(6018):714-7. 

17. Parker M. Use of a tablet to enhance standardization procedures in a randomized controlled trial. JMTM 2012;1(1):24-6. 

18. Parker M, Manan A, Duffett M. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort. Trials 2012;13:90.

19. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects: Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; the 35th WMA General Assembly, Venice, Italy, October 1983; the 41st WMA General Assembly, Hong Kong, September 1989; the 48th WMA General Assembly, Somerset West, South Africa, October 1996; the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000, the 53rd WMA General Assembly, Washington, DC, USA, October 2002; the 55th WMA General Assembly Tokyo, Japah, October 2004; the 59th WMA General Assembly, Seoul, Korea, October 2008. Ferney-Voltaire, France: World Medical Association1964.

20. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. In: Department of Health E, and Welfare., editor. Washington, D.C.: Government Printing Office; 1979.

21. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2 ed: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada; 2011.

22. Perera C. Principles of Security for the use of Mobile Technology in Medicine. JMTM 2012:5-7.