Sage Journals: Discover world-class research

Abstract

This study assessed mothers’ perspectives regarding research involvement by their children, factors that might affect perceptions of research risks, and attitudes regarding willingness to enroll children in research. Participants completed a survey on Amazon Mechanical Turk. Mothers were less inclined to enroll children in research involving procedures posing higher risk (regression coefficient = −0.51). Mothers without mental health issues with children without health issues were more sensitive to risk than mothers without mental health issues with children with health issues (estimated difference = 0.49). Mothers with mental health issues were more willing than mothers without mental health issues to enroll children in research (regression coefficient = −0.90). Among mothers with mental health issues, having a child with a health issue was associated with increased willingness to enroll in research, compared with having children without health issues (estimated difference = 0.65).

Keywords

research enrollment perceptions attitudes children mothers

Get full access to this article

View all access options for this article.

References

Allmark

Mason

(2006). Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process. Journal of Medical Ethics, 32(8), 439–443. https://doi.org/10.1136/jme.2005.013722

Arevalo

Heredia

N. I.

Krasny

Rangel

M. L.

Gatus

L. A.

McNeill

L. H.

Fernandez

M. E.

(2016). Mexican-American perspectives on participation in clinical trials: A qualitative study. Contemporary Clinical Trials Communications, 4, 52–57. https://doi.org/10.1016/j.conctc.2016.06.009

Baek

Kwon

Chae

J.-H.

Chung

Y. A.

Kralik

J. D.

Min

J.-A.

… Jeong

(2017). Heightened aversion to risk and loss in depressed patients with a suicide attempt history. Nature Publishing Group, 7(1), Article 11228. https://doi.org/10.1038/s41598-017-10541-5

Baker

J. N.

Leek

A. C.

Salas

H. S.

Drotar

Noll

Rheingold

S. R.

Kodish

E. D.

(2013). Suggestions from adolescents, young adults, and parents for improving informed consent in phase 1 pediatric oncology trials. Cancer, 119(23), 4154–4161. https://doi.org/10.1002/cncr.28335

Barry

M. J.

Edgman-Levitan

(2012). Shared decision making—The pinnacle of patient-centered care. The New England Journal of Medicine, 366(9), 780–781. https://doi.org/10.1056/NEJMp1109283

Barsdorf

N. W.

Wassenaar

D. R.

(2005). Racial differences in public perceptions of voluntariness of medical research participants in South Africa. Social Science & Medicine, 60(5), 1087–1098. https://doi.org/10.1016/j.socscimed.2004.06.039

Benin

A. L.

(2006). Qualitative analysis of mothers’ decision-making about vaccines for infants: The importance of trust. Pediatrics, 117(5), 1532–1541. https://doi.org/10.1542/peds.2005-1728

Bentley

J. P.

Thacker

P. G.

(2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30(3), 293–298. https://doi.org/10.1136/jme.2002.001594

Boland

Graham

I. D.

Légaré

Lewis

Jull

Shephard

… Stacey

(2019). Barriers and facilitators of pediatric shared decision-making: A systematic review. Implementation Science, 14(1), Article 7. https://doi.org/10.1186/s13012-018-0851-5

10.

Caldwell

P. H. Y.

Butow

P. N.

Craig

J. C.

(2003). Parents’ attitudes to children’s participation in randomized controlled trials. The Journal of Pediatrics, 142(5), 554–559. https://doi.org/10.1067/mpd.2003.192

11.

Case

Paxson

(2001). Mothers and others: Who invests in children’s health? Journal of Health Economics, 20(3), 301–328. https://doi.org/10.3386/w7691

12.

Ceballos

R. M.

Knerr

Scott

M. A.

Hohl

S. D.

Malen

R. C.

Vilchis

Thompson

(2014). Latino beliefs about biomedical research participation: A qualitative study on the U.S.-Mexico border. Journal of Empirical Research on Human Research Ethics, 9(4), 10–21. https://doi.org/10.1177/1556264614544454

13.

Chandler

Mueller

Paolacci

(2013). Nonnaïveté among Amazon Mechanical Turk workers: Consequences and solutions for behavioral researchers. Behavior Research Methods, 46(1), 112–130. https://doi.org/10.3758/s13428-013-0365-7

14.

Chappuy

Doz

Blanche

Gentet

J.-C.

Pons

Tréluyer

J.-M.

(2006). Parental consent in paediatric clinical research. Archives of Disease in Childhood, 91(2), 112–116. https://doi.org/10.1136/adc.2005.076141

15.

Dekking

S. A. S.

van der Graaf

de Vries

M. C.

Bierings

M. B.

van Delden

J. J. M.

Kodish

Lantos

J. D.

(2015). Is a new protocol for acute lymphoblastic leukemia research or standard therapy? Pediatrics, 136(3), 566–570. https://doi.org/10.1542/peds.2014-2327

16.

Dekking

S. A. S.

van der Graaf

Kars

M. C.

Beishuizen

de Vries

M. C.

van Delden

J. J. M.

(2015). Balancing research interests and patient interests: A qualitative study into the intertwinement of care and research in paediatric oncology. Pediatric Blood & Cancer, 62(5), 816–822. https://doi.org/10.1002/pbc.25444

17.

Dunn

L. B.

Fisher

S. R.

Hantke

Appelbaum

P. S.

Dohan

Young

J. P.

Roberts

L. W.

(2013). “Thinking about it for somebody else”: Alzheimer’s disease research and proxy decision makers’ translation of ethical principles into practice. The American Journal of Geriatric Psychiatry, 21(4), 337–345. https://doi.org/10.1016/j.jagp.2012.11.014

18.

Dunn

L. B.

Kim

D. S.

Fellows

I. E.

Palmer

B. W.

(2009). Worth the risk? Relationship of incentives to risk and benefit perceptions and willingness to participate in schizophrenia research. Schizophrenia Bulletin, 35(4), 730–737. https://doi.org/10.1093/schbul/sbn003

19.

Eder

M. L.

Yamokoski

A. D.

Wittmann

P. W.

Kodish

E. D.

(2007). Improving informed consent: Suggestions from parents of children with leukemia. Pediatrics, 119(4), e849–e859. https://doi.org/10.1542/peds.2006-2208

20.

Fisher

H. R.

McKevitt

Boaz

(2011). Why do parents enroll their children in research: A narrative synthesis. Journal of Medical Ethics, 37(9), 544–551. https://doi.org/10.1136/jme.2010.040220

21.

Ford

J. G.

Howerton

M. W.

Lai

G. Y.

Gary

T. L.

Bolen

Gibbons

M. C.

… Bass

E. B.

(2008). Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer, 112(2), 228–242. https://doi.org/10.1002/cncr.23157

22.

Gammelgaard

Knudsen

L. E.

Bisgaard

(2006). Perceptions of parents on the participation of their infants in clinical research. Archives of Disease in Childhood, 91(12), 977–980. https://doi.org/10.1136/adc.2006.096073

23.

Gardner

R. A.

Finney

Annesley

Brakke

Summers

Leger

… Jensen

M. C

. (2017). Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults. Blood, 129(25), 3322–3331. https://doi.org/10.1182/blood-2017-02-769208

24.

Gillan

C. M.

Daw

N. D.

(2016). Taking psychiatry research online. Neuron, 91(1), 19–23. https://doi.org/10.1016/J.NEURON.2016.06.002

25.

Gross

G. J.

Howard

(2001). Mothers’ decision-making processes regarding health care for their children. Public Health Nursing, 18(3), 157–168. https://doi.org/10.1046/j.1525-1446.2001.00157.x

26.

Heredia

N. I.

Krasny

Strong

L. L.

Von Hatten

Nguyen

Reininger

B. M.

… Fernández

M. E.

(2017). Community perceptions of biobanking participation: A qualitative study among Mexican-Americans in three Texas cities. Public Health Genomics, 20(1), 46–57. https://doi.org/10.1159/000452093

27.

Hoberman

Shaikh

Bhatnagar

Haralam

M. A.

Kearney

D. H.

Colborn

D. K.

… Chesney

R. W.

(2013). Factors that influence parental decisions to participate in clinical research. JAMA Pediatrics, 167(6), 561–566. https://doi.org/10.1001/jamapediatrics.2013.1050

28.

Jones

Pietilä

Joronen

Simpson

Gray

Kaunonen

(2016). Parents with mental illness—A qualitative study of identities and experiences with support services. Journal of Psychiatric and Mental Health Nursing, 23(8), 471–478. https://doi.org/10.1111/jpm.12321

29.

Knowles

Tai

Christensen

Bentall

(2005). Coping with depression and vulnerability to mania: A factor analytic study of the Nolen-Hoeksema (1991) Response Styles Questionnaire. The British Journal of Clinical Psychology, 44(Pt 1), 99–112.

30.

Kodish

(2003). Informed consent for pediatric research: Is it really possible? The Journal of Pediatrics, 142(2), 89–90.

31.

Kramer

E. L.

Clancy

J. P.

(2016). CFTR modulator therapies in pediatric cystic fibrosis: Focus on Ivacaftor. Expert Opinion on Orphan Drugs, 4(10), 1033–1042. https://doi.org/10.1080/21678707.2016.1226800

32.

Lee

D. W.

Kochenderfer

J. N.

Stetler-Stevenson

Cui

Y. K.

Delbrook

Feldman

S. A.

… Mackall

C. L.

(2015). T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: A phase 1 dose-escalation trial. Lancet, 385(9967), 517–528. https://doi.org/10.1016/S0140-6736(14)61403-3

33.

Leibson

Koren

(2015). Informed consent in pediatric research. Pediatric Drugs, 17(1), 5–11. https://doi.org/10.1007/s40272-014-0108-y

34.

Leykin

Roberts

C. S.

DeRubeis

R. J.

(2010). Decision-making and depressive symptomatology. Cognitive Therapy and Research, 35(4), 333–341. https://doi.org/10.1007/s10608-010-9308-0

35.

Lipstein

E. A.

Lindly

O. J.

Anixt

J. S.

Britto

M. T.

Zuckerman

K. E.

(2016). Shared decision making in the care of children with developmental and behavioral disorders. Maternal and Child Health Journal, 20(3), 665–673. https://doi.org/10.1007/s10995-015-1866-z

36.

Loewenstein

O’Donoghue

Rabin

(2003). Projection bias in predicting future utility. Quarterly Journal of Economics, 4(1), 1209–1248. https://doi.org/10.1162/003355303322552784

37.

Mack

J. W.

Wolfe

Cook

E. F.

Grier

H. E.

Cleary

P. D.

Weeks

J. C.

(2011). Parents’ roles in decision making for children with cancer in the first year of cancer treatment. Journal of Clinical Oncology, 29(15), 2085–2090. https://doi.org/10.1200/JCO.2010.32.0507

38.

Mainous

A. G.

Smith

D. W.

Geesey

M. E.

Tilley

B. C.

(2006). Development of a measure to assess patient trust in medical researchers. Annals of Family Medicine, 4(3), 247–252. https://doi.org/10.1370/afm.541

39.

Maude

S. L.

Frey

Shaw

P. A.

Aplenc

Barrett

D. M.

Bunin

N. J.

… Grupp

S. A

. (2014). Chimeric antigen receptor T cells for sustained remissions in leukemia. The New England Journal of Medicine, 371(16), 1507–1517. https://doi.org/10.1056/NEJMoa1407222

40.

Minkovitz

C. S.

O’Campo

P. J.

Chen

Y-H.

Grason

H. A.

(2002). Associations between maternal and child health status and patterns of medical care use. Ambulatory Pediatrics, 2(2), 85–92. https://doi.org/10.1367/1539-4409(2002)002<0085:ABMACH>2.0.CO;2

41.

Miu

A. C.

Heilman

R. M.

Houser

(2008). Anxiety impairs decision-making: Psychophysiological evidence from an Iowa Gambling Task. Biological Psychology, 77(3), 353–358. https://doi.org/10.1016/j.biopsycho.2007.11.010

42.

Office for Human Research Protections. (2016). Special protections for children as research subjects. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/special-protections-for-children/index.html

43.

Opel

D. J.

(2018). A 4-step framework for shared decision-making in pediatrics. Pediatrics, 142(Suppl. 3), S149–S156. https://doi.org/10.1542/peds.2018-0516E

44.

Overton

Appelbaum

P. S.

Fisher

S. R.

Dohan

Roberts

L. W.

Dunn

L. B.

(2013). Alternative decision-makers’ perspectives on assent and dissent for dementia research. American Journal of Geriatric Psychiatry, 21(4), 346–354.

45.

Paolacci

Chandler

Ipeirotis

(2010). Running experiments on Amazon Mechanical Turk. Judgment and Decision Making, 5(5), 411–419.

46.

Phares

Compas

B. E.

(1992). The role of fathers in child and adolescent psychopathology: Make room for daddy. Psychological Bulletin, 111(3), 387–412.

47.

Pickler

R. H.

Martin

A. T.

(2010). Protection of children in research. Journal of Pediatric Health Care, 24(1), 66–68. https://doi.org/10.1016/j.pedhc.2009.08.011

48.

Pridham

K. F.

Chang

A. S.

(1991). Mothers’ perceptions of problem-solving competence for infant care. Western Journal of Nursing Research, 13(2), 164–180. https://doi.org/10.1177/019394599101300202

49.

Ramanathan

(2006). Surfactant therapy in preterm infants with respiratory distress syndrome and in near-term or term newborns with acute RDS. Journal of Perinatology, 26(Suppl. 1), S51–S56. https://doi.org/10.1038/sj.jp.7211474

50.

Rampou

A. M.

Havenga

Madumo

(2015). Parenting experiences of mothers living with a chronic mental illness. Health SA Gesondheit, 20(1), 118–127. https://doi.org/10.1016/j.hsag.2015.04.004

51.

Roberts

L. W.

Hammond

K. A. G.

Warner

T. D.

Lewis

(2004). Influence of ethical safeguards on research participation: Comparison of perspectives of people with schizophrenia and psychiatrists. American Journal of Psychiatry, 161(12), 2309–2311. https://doi.org/10.1176/appi.ajp.161.12.2309

52.

Roberts

L. W.

Kim

J. P.

(2014). Giving voice to study volunteers: Comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research. Journal of Psychiatric Research, 56, 90–97. https://doi.org/10.1016/J.JPSYCHIRES.2014.05.007

53.

Roberts

L. W.

Kim

J. P.

(2017). Healthy individuals’ perspectives on clinical research protocols and influences on enrollment decisions. AJOB Empirical Bioethics, 8(2), 89–98. https://doi.org/10.1080/23294515.2016.1271062

54.

Roberts

L. W.

Warner

T. D.

Brody

J. L.

Roberts

Lauriello

Lyketsos

(2002). Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: Assessment of harm potential and factors influencing participation decisions. American Journal of Psychiatry, 159(4), 573–584. https://doi.org/10.1176/appi.ajp.159.4.573

55.

Rosenberg

A. R.

Orellana

Kang

T. I.

Geyer

J. R.

Feudtner

Dussel

Wolfe

(2014). Differences in parent-provider concordance regarding prognosis and goals of care among children with advanced cancer. Journal of Clinical Oncology, 32(27), 3005–3011. https://doi.org/10.1200/JCO.2014.55.4659

56.

Rossi

W. C.

Reynolds

Nelson

R. M.

(2003). Child assent and parental permission in pediatric research. Theoretical Medicine and Bioethics, 24(2), 131–148.

57.

Rothmier

J. D.

Lasley

M. V.

Shapiro

G. G.

(2003). Factors influencing parental consent in pediatric clinical research. Pediatrics, 111(5), 1037–1041.

58.

Scharf

D. P.

Mathews

K. J.

Jackson

Hofsuemmer

Martin

Edwards

(2010). More than Tuskegee: Understanding mistrust about research participation. Journal of Health Care for the Poor and Underserved, 21(3), 879–897. https://doi.org/10.1353/hpu.0.0323

59.

Shapiro

D. N.

Chandler

Mueller

P. A.

(2013). Using Mechanical Turk to study clinical populations. Clinical Psychological Science, 1(2), 213–220. https://doi.org/10.1177/2167702612469015

60.

Snow

(2012). The complete research suite: A step-by-step guide to using Qualtrics. https://www.nursing.upenn.edu/live/files/106-qualtrics-step-by-step-manualpdf

61.

Solomon

S. R.

(2013). Protecting and respecting the vulnerable: Existing regulations or further protections? Theoretical Medicine and Bioethics, 34(1), 17–28. https://doi.org/10.1007/s11017-013-9242-8

62.

Tait

A. R.

Voepel-Lewis

Malviya

(2003). Participation of children in clinical research: Factors that influence a parent’s decision to consent. Anesthesiology, 99(4), 819–825.

63.

Tarini

B. A.

Goldenberg

Singer

Clark

S. J.

Butchart

Davis

M. M.

(2010). Not without my permission: Parents’ willingness to permit use of newborn screening samples for research. Public Health Genomics, 13(3), 125–130. https://doi.org/10.1159/000228724

64.

Tromp

van de Vathorst

(2019). Parents’ perspectives on decisions to participate in pediatric clinical research: Results from a focus group study with laypeople. Journal of Empirical Research on Human Research Ethics, 14(3), 243–253. https://doi.org/10.1177/1556264619845599

65.

Tsevat

R. K.

Radecki Breitkopf

Landers

S. E.

de Roche

A. M.

Mauro

Ipp

L. S.

… Rosenthal

S. L.

(2018). Adolescents’ and parents’ attitudes toward adolescent clinical trial participation: Changes over one year. Journal of Empirical Research on Human Research Ethics, 13(4), 383–390. https://doi.org/10.1177/1556264618790889

66.

Tymchuk

A. J.

Yokota

Rahbar

(1990). Decision-making abilities of mothers with mental retardation. Research in Developmental Disabilities, 11(1), 97–109. https://doi.org/10.1016/0891-4222(90)90007-U

67.

Ward

F. R.

(2010). Parents’ views of involvement in concurrent research with their neonates. Journal of Empirical Research on Human Research Ethics, 5(2), 47–55. https://doi.org/10.1525/jer.2010.5.2.47

68.

Wiener

Viola

Wilfond

B. S.

Wendler

Grady

(2015). Contrasting views of risk perception and influence of financial compensation between adolescent research participants and their parents. Journal of Empirical Research on Human Research Ethics, 10(1), 49–58. https://doi.org/10.1177/1556264614563249

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.25 MB

Attitudes of Mothers Regarding Willingness to Enroll Their Children in Research

Abstract

Keywords

Get full access to this article

References

Supplementary Material