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Journal articles on the topic 'Consent in research'

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Published: 10 December 2022
Last updated: 28 January 2023

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1

Menon, David K., and Kathleen Liddell. "Consent for Research." Journal of the Intensive Care Society 5, no. 3 (October 2004): 98–99. http://dx.doi.org/10.1177/175114370400500307.

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2

Biros, Michelle H. "Research without consent." Annals of Emergency Medicine 42, no. 4 (October 2003): 550–64. http://dx.doi.org/10.1067/s0196-0644(03)00490-6.

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3

Loverde, Mary E., Allan V. Prochazka, and Richard L. Byyny. "Research consent forms." Journal of General Internal Medicine 4, no. 5 (September 1989): 410–12. http://dx.doi.org/10.1007/bf02599693.

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4

Hadden, Kristie B., Latrina Y. Prince, Tina D. Moore, Laura P. James, Jennifer R. Holland, and Christopher R. Trudeau. "Improving readability of informed consents for research at an academic medical institution." Journal of Clinical and Translational Science 1, no. 6 (December 2017): 361–65. http://dx.doi.org/10.1017/cts.2017.312.

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IntroductionThe final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.MethodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.
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5

Parija, SubhashChandra, and Jharna Mandal. "Informed consent and research." Tropical Parasitology 4, no. 2 (2014): 78. http://dx.doi.org/10.4103/2229-5070.138533.

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6

Floyd, Jeanne. "Research & Informed CONSENT." Journal of Psychosocial Nursing and Mental Health Services 26, no. 3 (March 1988): 13–21. http://dx.doi.org/10.3928/0279-3695-19880301-07.

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7

Sriram, Preethi. "Remote Consent Clinical Research." Clinical Trials and Practice – Open Journal 2, no. 1 (December 31, 2019): 22–24. http://dx.doi.org/10.17140/ctpoj-2-109.

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Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the usage of the utilization of remote consent options for these trials.
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8

Kaczor, Christopher. "Fetal Research and Consent." Ethics & Medics 26, no. 5 (2001): 3–4. http://dx.doi.org/10.5840/em200126510.

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9

Kaul, B., and R. Cork. "Consent to clinical research." Anaesthesia 46, no. 10 (October 1991): 885–86. http://dx.doi.org/10.1111/j.1365-2044.1991.tb09611.x.

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10

Taub, Harvey A., Marilyn T. Baker, and Joseph F. Sturr. "Informed Consent for Research." Journal of the American Geriatrics Society 34, no. 8 (August 1986): 601–6. http://dx.doi.org/10.1111/j.1532-5415.1986.tb05766.x.

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11

Veatch, Robert M. "Consent, Confidentiality, and Research." New England Journal of Medicine 336, no. 12 (March 20, 1997): 869–70. http://dx.doi.org/10.1056/nejm199703203361209.

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12

Benatar, D., and S. R. Benatar. "Informed consent and research." BMJ 316, no. 7136 (March 28, 1998): 1008–10. http://dx.doi.org/10.1136/bmj.316.7136.1008.

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13

Truog, Robert D., and Walter Robinson. "Informed Consent for Research." Anesthesiology 90, no. 6 (June 1, 1999): 1499–501. http://dx.doi.org/10.1097/00000542-199906000-00002.

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14

Rothstein, Mark A., and Abigail B. Shoben. "Does Consent Bias Research?" American Journal of Bioethics 13, no. 4 (April 2013): 27–37. http://dx.doi.org/10.1080/15265161.2013.767955.

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15

BELL, EMILY, ERIC RACINE, PAULA CHIASSON, MAYA DUFOURCQ-BRANA, LAURA B. DUNN, JOSEPH J. FINS, PAUL J. FORD, et al. "Beyond Consent in Research." Cambridge Quarterly of Healthcare Ethics 23, no. 3 (May 27, 2014): 361–68. http://dx.doi.org/10.1017/s0963180113000984.

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16

Peduzzi, Peter, Peter Guarino, Sam T. Donta, Charles C. Engel, Daniel J. Clauw, and John R. Feussner. "Research on informed consent." Controlled Clinical Trials 23, no. 2 (April 2002): 184–97. http://dx.doi.org/10.1016/s0197-2456(01)00167-2.

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17

McKechnie, L. "Consent for neonatal research." Archives of Disease in Childhood - Fetal and Neonatal Edition 91, no. 5 (September 1, 2006): F374—F376. http://dx.doi.org/10.1136/adc.2005.075036.

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18

Coats, T. J. "Consent in emergency research." Emergency Medicine Journal 23, no. 6 (June 1, 2006): 489–90. http://dx.doi.org/10.1136/emj.2005.031005.

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19

Menikoff, Jerry. "Making Research Consent Transparent." JAMA 304, no. 15 (October 20, 2010): 1713. http://dx.doi.org/10.1001/jama.2010.1492.

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20

Frelich, Matthew J., Matthew E. Bosler, and Jon C. Gould. "Research Electronic Data Capture (REDCap) electronic Informed Consent Form (eICF) is compliant and feasible in a clinical research setting." International Journal of Clinical Trials 2, no. 3 (August 13, 2015): 51. http://dx.doi.org/10.18203/2349-3259.ijct20150591.

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<p class="abstract"><strong>Background:</strong> Electronic consent for research has shown success in clinical trial models, but has not been rigorously evaluated as an alternative to conventional paper consent. We sought to design a 21 CFR Part 11 compliant iPad-based electronic Informed Consent Form (eICF) with Research Electronic Data Capture (REDCap). As a secondary aim, we sought to compare subject workload between eICF and paper consent groups.</p><p class="abstract"><strong>Methods:</strong> This is a prospective, randomized study of subjects who completed an iPad-based eICF versus paper consent for research. The eICF was designed with REDCap and presented on an iPad. Subject workload was measured with the NASA Task Load Index (NASA-TLX) and subjective feedback in regards to consent process was collected.</p><p class="abstract"><strong>Results:</strong> A total of 116 subjects were screened for consent. Of which, 51 (44%) subjects provided informed consent and completed all study related procedures. Twenty-five (49%) eICF and 26 (51%) paper consents were completed. The eICF group rated a significantly greater preference to use the eICF for future research studies (6.4±1.5) compared to the paper consent group (5.0±1.9), p&lt;0.01. There were no significant differences in NASA-TLX Weighted Scale or Total-TLX Scores between groups. One error resulted in the eICF group due to an inadvertent submission by a single subject.</p><p class="abstract"><strong>Conclusion:</strong> In summary, we have demonstrated that an iPad-based eICF designed with REDCap is both 21 CFR Part 11 compliant and feasible in the clinical research setting. The eICF does not appear to be more technically difficult or demanding than conventional paper consent.</p>
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21

Biros, Michelle H. "Research without Consent: Exception from and Waiver of Informed Consent in Resuscitation Research." Science and Engineering Ethics 13, no. 3 (July 28, 2007): 361–69. http://dx.doi.org/10.1007/s11948-007-9020-y.

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22

Astell, Arlene J. "Consent for research and treatment." FPOP Bulletin: Psychology of Older People 1, no. 87 (August 2004): 5–10. http://dx.doi.org/10.53841/bpsfpop.2004.1.87.5.

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AbstractThe informed consent process is intimately related to autonomy and the capacity to make decisions. This relationship between consent and capacity has legal, ethical and practice considerations, which are briefly reviewed in this paper. Specifically the legal requirements for assessing capacity to give consent, situations in which consent should be sought and approaches to assessing capacity to consent are reviewed. In addition, actions to be taken with regard to people who are judged incapable of giving consent are considered, in particular proxy decision-making and advance discussion of wishes. Recommendations for good practice in the consent process are also briefly examined. Whenever possible evidence relating to older adults is considered, however this review highlights the need for more research in this area.
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23

Kluge, Eike-Henner W. "Informed Consent in Health Research." International Journal of Pharmaceutical Medicine 21, no. 6 (2007): 405–14. http://dx.doi.org/10.2165/00124363-200721060-00005.

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24

Fost, Norman. "Waived Consent for Emergency Research." American Journal of Law & Medicine 24, no. 2-3 (1998): 163–83. http://dx.doi.org/10.1017/s009885880001039x.

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The voluntary consent of the human subject is absolutely essential.Contrary to the first principle of the Nuremberg Code, the voluntary consent of the human subject is neither necessary nor sufficient for ethically and legally responsible research in the United States. That it is not sufficient has been well argued by Robert Burt and others. We would not say that the central problem of the Nazi experiments was their failure to obtain informed consent. Nor would the presentation of signed and witnessed consent forms change anyone's view on the moral justification for the experiments. For related reasons, institutional review boards (IRBs) sometimes reject or defer protocols for paternalistic or various other reasons, arguing that clinicians should not allow patients to consent to be subjects in a study.
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25

Kuehn, Mary Beth, Devyn Hotho, and Maggie Prunty. "Parental Consent for Adolescent Research." Creative Nursing 22, no. 1 (2016): 51–55. http://dx.doi.org/10.1891/1078-4535.22.1.51.

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The purpose of this article is to increase understanding about how to obtain institutional review board approval to waive parental consent for adolescent research that involves minimal risk to subjects and/or that cannot be carried out practicably without the waiver. Because of IRB guidelines, the researchers were unable to use passive parental consent for a study of adolescent nonmedical prescription drug use (NMPDU). Without knowledge of waiver 45 C.F.R. §46.116 of the U.S. Department of Health and Human Services Code of Federal Regulations regarding the protection of human research subjects, the study design required active parental consent for survey administration. This requirement limited study participation and increased costs. Using the waiver, the study design could have waived parental consent with adolescent assent. By increasing awareness of the 45 C.F.R. §46.116 waiver and its subparts, the researchers hope to inform future researchers about reducing barriers to future adolescent research. Lessons learned include how using the waiver may decrease research costs, reduce participant selection bias, increase participant response rate, and expand data available to contribute to critical, emerging adolescent health issues such as NMPDU.
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26

Marshall, Eliot. "Panel Faults Research Consent Process." Science 270, no. 5233 (October 6, 1995): 25. http://dx.doi.org/10.1126/science.270.5233.25.a.

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27

Sachs, Benjamin. "The Timing of Research Consent." Ethical Theory and Moral Practice 24, no. 4 (September 2021): 1033–46. http://dx.doi.org/10.1007/s10677-021-10224-1.

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AbstractThis essay is about the timing of research consent, a process that involves (potential) participants being given information about, among other things, upcoming research interventions and then being invited to waive their claims against those interventions being undertaken. The standard practice, as regards timing, is as follows: (potential) participants are invited to waive all their claims at a single moment in time, and that point in time immediately follows the information-provision. I argue that there we’re not justified in keeping to this practice. What we ought to do is disaggregate the claim-waiving part of the process and move it later, such that the (potential) participant is invited to waive her claim against the undertaking of any given intervention only the immediate moment before that intervention is to be undertaken.
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28

DeRenzo, E. G. "Informed consent in medical research." British Journal of Cancer 85, no. 11 (November 27, 2001): 1811–12. http://dx.doi.org/10.1054/bjoc.2001.2135.

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29

Pinals, Debra A., Anil K. Malhotra, and Alan Breier. "Informed Consent in Schizophrenia Research." Psychiatric Services 49, no. 2 (February 1998): 244. http://dx.doi.org/10.1176/ps.49.2.244.

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30

Evans, John Grimley, and Peter Beck. "Informed consent in medical research." Clinical Medicine 2, no. 3 (May 1, 2002): 267–72. http://dx.doi.org/10.7861/clinmedicine.2-3-267.

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31

Shrivastava, SaurabhR, Prateek Shrivastava, and Jegadeesh Ramasamy. "Informed consent in clinical research." CHRISMED Journal of Health and Research 2, no. 2 (2015): 183. http://dx.doi.org/10.4103/2348-3334.153275.

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32

STOKOWSKI, LAURA A. "Informed Consent for Neonatal Research." Advances in Neonatal Care 9, no. 4 (August 2009): 143. http://dx.doi.org/10.1097/01.anc.0000360167.67208.98.

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33

Hanser, Matthew. "Risky research and bystander consent." Bioethics 34, no. 9 (September 29, 2020): 912–17. http://dx.doi.org/10.1111/bioe.12811.

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34

Tindall, Gillian. "Patient Research and Informed Consent." Journal of the Royal Society of Medicine 83, no. 5 (May 1990): 337–39. http://dx.doi.org/10.1177/014107689008300525.

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35

Bloch, Sidney, and Michael Salzberg. "Informed consent in psychiatric research." Current Opinion in Psychiatry 16, no. 6 (November 2003): 679–84. http://dx.doi.org/10.1097/00001504-200311000-00013.

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36

Reiman, Robert E. "Informed Consent in Human Research." Health Physics 104 (February 2013): S17—S22. http://dx.doi.org/10.1097/hp.0b013e318271b4c9.

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37

Davies, Teifion. "Informed consent in psychiatric research." British Journal of Psychiatry 178, no. 5 (May 2001): 397–98. http://dx.doi.org/10.1192/bjp.178.5.397.

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38

Sachs, Greg A. "Advance Consent for Dementia Research." Alzheimer Disease & Associated Disorders 8, no. 4 (1994): 19–27. http://dx.doi.org/10.1097/00002093-199400000-00003.

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39

Sachs, Greg A. "Advance Consent for Dementia Research." Alzheimer Disease & Associated Disorders 8 (1994): 19–27. http://dx.doi.org/10.1097/00002093-199424003-00003.

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40

Minkoff, Howard L., and Jonathan D. Moreno. "Paternal Consent for Fetal Research." New England Journal of Medicine 329, no. 4 (July 22, 1993): 278. http://dx.doi.org/10.1056/nejm199307223290413.

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41

Schmidt, K. "Informed Consent in Medical Research." Focus on Alternative and Complementary Therapies 6, no. 4 (June 14, 2010): 301. http://dx.doi.org/10.1111/j.2042-7166.2001.tb03168.x.

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42

Lemaire, F. "Waiving consent for emergency research." European Journal of Clinical Investigation 35, no. 5 (May 2005): 287–89. http://dx.doi.org/10.1111/j.1365-2362.2005.01493.x.

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43

Janssens, A. Cecile JW, Eline M. Bunnik, Wylie Burke, and Maartje HN Schermer. "Uninformed consent in nutrigenomic research." European Journal of Human Genetics 25, no. 7 (May 10, 2017): 789–90. http://dx.doi.org/10.1038/ejhg.2017.63.

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44

Allmark, P. "Obtaining consent for neonatal research." Archives of Disease in Childhood - Fetal and Neonatal Edition 88, no. 3 (May 1, 2003): 166F—167. http://dx.doi.org/10.1136/fn.88.3.f166.

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45

UZYCH, LEO. "Cells, Research, and Informed Consent." JNCI: Journal of the National Cancer Institute 83, no. 5 (March 6, 1991): 368. http://dx.doi.org/10.1093/jnci/83.5.368.

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46

Cox, N. H. "Informed consent to postmarketing research." BMJ 311, no. 7006 (September 9, 1995): 692. http://dx.doi.org/10.1136/bmj.311.7006.692.

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47

Bryan Gill, A. "Informed consent for neonatal research." Current Paediatrics 12, no. 6 (December 2002): 503–7. http://dx.doi.org/10.1054/cupe.2002.0333.

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48

Nelson, Robert M., and Jon F. Merz. "Voluntariness of Consent for Research." Medical Care 40, Supplement (September 2002): V—69—V—80. http://dx.doi.org/10.1097/00005650-200209001-00010.

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49

Flaherty, Derek. "Client consent for clinical research." Veterinary Anaesthesia and Analgesia 39, no. 4 (July 2012): 448. http://dx.doi.org/10.1111/j.1467-2995.2011.00688.x.

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50

Warner, James, and Erum Nomani. "Giving consent in dementia research." Lancet 372, no. 9634 (July 2008): 183–85. http://dx.doi.org/10.1016/s0140-6736(08)61049-1.

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