Skip to main content
SpringerLink
Log in

Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking

  • Full Length Paper
  • Published:
Cell and Tissue Banking Aims and scope Submit manuscript

Abstract

The ability to generate human induced pluripotent stem cells (iPSCs) has opened new avenues for human disease modelling and therapy. The aim of our study was to determine research participants’ understanding of the information given when donating skin biopsies for the generation of patient-specific iPSCs. A customised 35-item questionnaire based on previous iPSC consent guidelines was sent to participants who had previously donated samples for iPSC research. The questionnaire asked pertinent demographic details, participants' motivation to take part in iPSC research and their attitudes towards related ethical issues. 234 participants were contacted with 141 (60.3 %) complete responses received. The median duration between recruitment and follow-up questioning was 313 days (range 10–573 days). The majority of participants (n = 129, 91.5 %) believed they understood what a stem cell was; however, only 22 (16.1 %) correctly answered questions related to basic stem cell properties. We found no statistically significant difference in responses from participants with different levels of education, or those with a health sciences background. The poor understanding amongst participants of iPSC research is unlikely to be unique to our study and may impact future research if not improved. As such, there is a need to develop an easily understood yet comprehensive consent process to ensure ongoing ethical progress of iPSC biobanking.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  • Aalto-Setala K, Conklin BR, Lo B (2009) Obtaining consent for future research with induced pluripotent cells: opportunities and challenges. PLoS Biol 7:e42

    Article  PubMed  Google Scholar 

  • Ahsanuddin S, Bento S, Swerdlow N, Cervera I, Kayler LK (2015) Candidate comprehension of key concepts in kidney transplantation. Ann Transpl 20:124–131

    Article  Google Scholar 

  • Collins D (2003) Pretesting survey instruments: an overview of cognitive methods. Qual Life Res 12:229–238

    Article  PubMed  Google Scholar 

  • Crepeau AE, McKinney BI, Fox-Ryvicker M, Castelli J, Penna J, Wang ED (2011) Prospective evaluation of patient comprehension of informed consent. J Bone Joint Surg Am 93(e114):111–117

    Google Scholar 

  • Dasgupta I, Bollinger J, Mathews DJ, Neumann NM, Rattani A, Sugarman J (2014) Patients’ attitudes toward the donation of biological materials for the derivation of induced pluripotent stem cells. Cell Stem Cell 14:9–12

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Dathatri S, Gruberg L, Anand J, Romeiser J, Sharma S, Finnin E, Shroyer AL, Rosengart TK (2014) Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods. Ann Thorac Surg 97:1505–1511 (discussion 1511–1502)

    Article  PubMed  Google Scholar 

  • Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J et al (2010) Predictors of comprehension during surgical informed consent. J Am Coll Surg 210:919–926

    Article  PubMed  Google Scholar 

  • Glicksman JT, Sherman I, Rotenberg BW (2014) Informed consent when prescribing medication: a randomized controlled trial. Laryngoscope 124:1296–1300

    Article  PubMed  Google Scholar 

  • Johnson MR, Singh JA, Stewart T, Gioe TJ (2011) Patient understanding and satisfaction in informed consent for total knee arthroplasty: a randomized study. Arthritis Care Res (Hoboken) 63:1048–1054

    Article  Google Scholar 

  • Khan A, Capps BJ, Sum MY, Kuswanto CN, Sim K (2014) Informed consent for human genetic and genomic studies: a systematic review. Clin Genet 86:199–206

    Article  CAS  PubMed  Google Scholar 

  • Kobold S, Guhr A, Kurtz A, Loser P (2015) Human embryonic and induced pluripotent stem cell research trends: complementation and diversification of the field. Stem Cell Rep 4:914–925

    Article  CAS  Google Scholar 

  • Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A (1993) Factors affecting quality of informed consent. BMJ 306:885–890

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Li FX, Nah SA, Low Y (2014) Informed consent for emergency surgery—How much do parents truly remember? J Pediatr Surg 49:795–797

    Article  PubMed  Google Scholar 

  • Lomax GP, Hull SC, Isasi R (2015) The DISCUSS Project: revised points to consider for the derivation of induced pluripotent stem cell lines from previously collected research specimens. Stem Cells Transl Med 4:123–129

    Article  PubMed  PubMed Central  Google Scholar 

  • Lowenthal J, Lipnick S, Rao M, Hull SC (2012) Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent. Stem Cells Transl Med 1:409–421

    Article  PubMed  PubMed Central  Google Scholar 

  • McCarthy M (2013) NIH and family of Henrietta Lacks reach agreement on access to HeLa genome. BMJ 347:f5041

    Article  PubMed  Google Scholar 

  • Park IH, Zhao R, West JA, Yabuuchi A, Huo H, Ince TA, Lerou PH, Lensch MW, Daley GQ (2008) Reprogramming of human somatic cells to pluripotency with defined factors. Nature 451:141–146

    Article  CAS  PubMed  Google Scholar 

  • Robinson JO, Slashinski MJ, Wang T, Hilsenbeck SG, McGuire AL (2013) Participants’ recall and understanding of genomic research and large-scale data sharing. J Empir Res Hum Res Ethics 8:42–52

    Article  PubMed  PubMed Central  Google Scholar 

  • Rouhani F, Kumasaka N, de Brito MC, Bradley A, Vallier L, Gaffney D (2014) Genetic background drives transcriptional variation in human induced pluripotent stem cells. PLoS Genet 10:e1004432

    Article  PubMed  PubMed Central  Google Scholar 

  • Sepucha KR, Fagerlin A, Couper MP, Levin CA, Singer E, Zikmund-Fisher BJ (2010) How does feeling informed relate to being informed? The DECISIONS survey. Med Decis Making 30:77S–84S

    Article  PubMed  Google Scholar 

  • Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, Yamanaka S (2007) Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell 131:861–872

    Article  CAS  PubMed  Google Scholar 

  • Tam NT, Huy NT, le Thoa TB, Long NP, Trang NT, Hirayama K, Karbwang J (2015) Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ 93:186–198H

    Article  PubMed  PubMed Central  Google Scholar 

  • World Medical Association (2013) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 310:2191–2194

  • Yu J, Vodyanik MA, Smuga-Otto K, Antosiewicz-Bourget J, Frane JL, Tian S, Nie J, Jonsdottir GA, Ruotti V, Stewart R et al (2007) Induced pluripotent stem cell lines derived from human somatic cells. Science (New York. NY 318:1917–1920

    Article  CAS  Google Scholar 

Download references

Acknowledgments

This work was supported by grants from the National Health and Medical Research Council (NHMRC) (APP1059369, APP1023911), the BrightFocus Foundation (G2013136), Retina Australia, the Ophthalmic Research Institute of Australia and the Clifford Craig Medical Research Trust. EF, GR and AWH are funded by NHMRC Fellowships (APP1072987, APP1061801 and APP1103329, respectively), whilst AP is supported by an Australian Research Council Future Fellowship (FT140100047). CERA receives operational infrastructure support from the Victorian Government.

Author information

Authors and Affiliations

  1. Department of Surgery, Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, Australia

    Tristan McCaughey, Elisabeth De Smit, Gwyneth Rees, Eva Fenwick, Lisa S. Kearns, Alice Pébay & Alex W. Hewitt

  2. Department of Surgery, Monash University, Clayton, VIC, Australia

    Tristan McCaughey & Christine Y. Chen

  3. Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore

    Eva Fenwick

  4. Duke-NUS Medical School, Singapore, Singapore

    Eva Fenwick

  5. Lions Eye Institute, Centre for Ophthalmology and Visual Science, University of Western Australia, Perth, WA, Australia

    David A. Mackey & Alex W. Hewitt

  6. Menzies Institute for Medical Research, School of Medicine, University of Tasmania, Hobart, TAS, Australia

    David A. Mackey & Alex W. Hewitt

  7. School of Social Science, Monash University, Clayton, VIC, Australia

    Casimir MacGregor

  8. Stem Cells Australia, Department of Anatomy and Neuroscience, The University of Melbourne, Parkville, VIC, Australia

    Megan Munsie

  9. Wicking Dementia Research and Education Centre, University of Tasmania, Hobart, TAS, Australia

    Anthony L. Cook

Authors
  1. Tristan McCaughey
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Christine Y. Chen
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Elisabeth De Smit
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Gwyneth Rees
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Eva Fenwick
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Lisa S. Kearns
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. David A. Mackey
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Casimir MacGregor
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Megan Munsie
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Anthony L. Cook
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Alice Pébay
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Alex W. Hewitt
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Alex W. Hewitt.

Ethics declarations

Conflict of interest

The authors declare no potential conflicts of interest related to this work.

Additional information

Alice Pébay and Alex W. Hewitt have jointly supervised this work.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplemental Item 1 Participant information sheet (PDF 73 kb)

Supplemental Item 2 Participant information brochure (PDF 2425 kb)

10561_2016_9563_MOESM3_ESM.pdf

Supplemental Item 3 Questionnaire gauging participants’ attitudes towards and understanding of iPSC consent (PDF 241 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

McCaughey, T., Chen, C.Y., De Smit, E. et al. Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking. Cell Tissue Bank 17, 449–456 (2016). https://doi.org/10.1007/s10561-016-9563-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10561-016-9563-8

Search

Navigation