Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet “app”) with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.
AtkinsonS. (2019, February28). Newborn screening follow up program. Michigan Department of Health and Human Services.
2.
BrehautJ. C.O’ConnorA. M.WoodT. J.HackT. F.SiminoffL.GordonE.Feldman-StewartD. (2003). Validation of a decision regret scale. Medical Decision Making, 23(4), 281–292. https://doi.org/10.1177/0272989x03256005
3.
D’AbramoF.SchildmannJ.VollmannJ. (2015). Research participants’ perceptions and views on consent for biobank research: A review of empirical data and ethical analysis. BMC Medical Ethics, 16, Article 60. https://doi.org/10.1186/s12910-015-0053-5
4.
FloryJ.EmanuelE. (2004). Interventions to improve research participants’ understanding in informed consent for research: A systematic review. Journal of the American Medical Association, 292(13), 1593–1601. https://doi.org/10.1001/jama.292.13.1593
5.
GradyC.EcksteinL.BerkmanB.BrockD.Cook-DeeganR.FullertonS. M.. . . WendlerD. (2015). Broad consent for research with biological samples: Workshop conclusions. The American Journal of Bioethics, 15(9), 34–42. https://doi.org/10.1080/15265161.2015.1062162
LewisM. H.GoldenbergA.AndersonR.RothwellE.BotkinJ. (2011). State laws regarding the retention and use of residual newborn screening blood samples. Pediatrics, 127(4), 703–712. https://doi.org/10.1542/peds.2010-1468
8.
MayerR. E. (2002). Multimedia learning. Psychology of Learning and Motivation, 41, 85–139.
9.
MayerR. E.HeiserJ.LonnS. (2001). Cognitive constraints on multimedia learning: When presenting more material results in less understanding. Journal of Educational Psychology, 93(1), 187–198. https://doi.org/10.1037/0022-0663.93.1.187
10.
OrmondK. E.CirinoA. L.HelenowskiI. B.ChisholmR. L.WolfW. A. (2009). Assessing the understanding of biobank participants. American Journal of Medical Genetics, Part A, 149A(2), 188–198. https://doi.org/10.1002/ajmg.a.32635
11.
PaasF.RenklA.SwellerJ. (2003). Cognitive load theory and instructional design: Recent developments. Educational Psychologist, 38(1), 1–4. https://doi.org/10.1207/S15326985EP3801_1
12.
PalmerB. W.LanouetteN. M.JesteD. V. (2012). Effectiveness of multimedia aids to enhance comprehension of research consent information: A systematic review. IRB: Ethics & Human Research, 34(6), 1–15.
13.
RothwellE.GoldenbergA.JohnsonE.RichesN.TariniB.BotkinJ. R. (2017). An assessment of a shortened consent form for the storage and research use of residual newborn screening blood spots. Journal of Empirical Research on Human Research Ethics, 12(5), 335–342. https://doi.org/10.1177/1556264617736199
14.
RothwellE.JohnsonE.RichesN.BotkinJ. R. (2019). Secondary research uses of residual newborn screening dried bloodspots: A scoping review. Genetics in Medicine, 21(7), 1469–1475. https://doi.org/10.1038/s41436-018-0387-8
15.
RothwellE.WongB.RoseN. C.AndersonR.FedorB.StarkL. A.BotkinJ. R. (2014). A randomized controlled trial of an electronic informed consent process. Journal of Empirical Research on Human Research Ethics, 9(5), 1–7. https://doi.org/10.1177/1556264614552627
16.
SandersonS. C.BrothersK. B.MercaldoN. D.ClaytonE. W.AntommariaA. H. M.AufoxS. A.. . . HolmI. A. (2017). Public attitudes toward consent and data sharing in biobank research: A large multi-site experimental survey in the US. The American Journal of Human Genetics, 100(3), 414–427. https://doi.org/10.1016/j.ajhg.2017.01.021
