REVIEW PAPER
Informed consent process: challenges in clinical practice
 
 
More details
Hide details
1
Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, India
 
 
Submission date: 2020-09-08
 
 
Acceptance date: 2020-11-10
 
 
Publication date: 2022-12-19
 
 
Physiother Quart. 2022;30(4):27-29
 
KEYWORDS
TOPICS
ABSTRACT
The concept of informed consent dates back to nearly a century ago. It was instituted with the aim to safeguard a patient from unreasonable intrusion and abuse to their body integrity and to enrich patients with the ability of own choice for selecting the type of treatment as per their will. In other words, any action by a clinician, either for trial or practice purposes, involving an intrusion inside the patient’s body has to be conducted only after the approval of the patient (if conscious) or acceptance from family members, relatives, or friends of the patient (if unconscious). Application of informed consent prior to any procedure follows its implementation called ‘informed consent process’. In the present review article, the author focused on the challenge encountered by clinicians while implementing an informed consent process. Various databases were searched from inception to August 2020. Only English language articles were searched, with the following keywords: "Informed consent", "Informed consent process", and "Consent form", linked with Boolean words "AND", "OR", and "NOT". Informed consent process implementation should overcome various setbacks which have been experienced by clinicians working in government and private hospitals, nursing homes, clinics, old age homes, etc. These challenges were discussed in this review under various headings for proper identification, justifying the cause and measures to minimize their impacts.
 
REFERENCES (26)
1.
Sutrop M. Viewpoint: how to avoid a dichotomy between autonomy and beneficence: from liberalism to communitarianism and beyond. J Intern Med. 2011;269(4):375–379; doi: 10.1111/j.1365-2796.2011.02349_2.x.
 
2.
Dankar FK, Gergely M, Dankar SK. Informed consent in biomedical research. Comput Struct Biotechnol J. 2019;17:463–474; doi: 10.1016/j.csbj.2019.03.010.
 
3.
Satyanarayana Rao KH. Informed consent: an ethical obligation or legal compulsion? J Cutan Aesthet Surg. 2008;1(1):33–35; doi: 10.4103/0974-2077.41159.
 
4.
Sepucha K, Ozanne E, Silvia K, Partridge A, Mulley AG Jr. An approach to measuring the quality of breast cancer decisions. Patient Educ Couns. 2007;65(2):261–269; doi: 10.1016/j.pec.2006.08.007.
 
5.
Habiba M, Jackson C, Akkad A, Kenyon S, Dixon-Woods M. Women’s accounts of consenting to surgery: is consent a quality problem? Qual Saf Health Care. 2004;13(6):422–427; doi: 10.1136/qhc.13.6.422.
 
6.
Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ. 2012;184(5):533–540; doi: 10.1503/cmaj.112120.
 
7.
Pandiya A. Readability and comprehensibility of informed consent forms for clinical trials. Perspect Clin Res. 2010;1(3):98–100.
 
8.
Singer PA. Recent advances: medical ethics. BMJ. 2000;321(7256):282–285; doi: 10.1136/bmj.321.7256.282.
 
9.
Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348(8):721–726; doi: 10.1056/NEJMsa021212.
 
10.
Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW. Comprehension during informed consent in a less-developed country. Lancet. 2002;360(9342):1301–1302; doi: 10.1016/S0140-6736(02)11338-9.
 
11.
Hudak PL, Frankel RM, Braddock C 3rd, Nisenbaum R, Luca P, McKeever C, et al. Do patients’ communication behaviors provide insight into their preferences for participation in decision making? Med Decis Making. 2008;28(3):385–393; doi: 10.1177/0272989X07312712.
 
12.
DeCosta A, D’Souza N, Krishnan S, Chhabra MS, Shihaam I, Goswami K. Community based trials and informed consent in rural north India. J Med Ethics. 2004;30(3):318–323; doi: 10.1136/jme.2002.001065.
 
13.
Gupta UC, Kharawala S. Informed consent in psychiatry clinical research: a conceptual review of issues, challenges, and recommendations. Perspect Clin Res. 2012;3(1):8–15; doi: 10.4103/2229-3485.92301.
 
14.
Kharawala S, Dalal J. Challenges in conducting psychiatry studies in India. Perspect Clin Res. 2011;2(1):8–12; doi: 10.4103/2229-3485.76284.
 
15.
Kocańda K, Głuszek S. Can a drunk patient give informed consent for medical treatment? Med Stud. 2019;35(3):243–245; doi: 10.5114/ms.2019.88424.
 
16.
Kadam RA. Informed consent process: a step further towards making it meaningful! Perspect Clin Res. 2017;8(3):107–112; doi: 10.4103/picr.PICR_147_16.
 
17.
Pawliczak R. Skin prick test and patient informed consent [in Polish]. Alergol Pol – Polish J Allergol. 2020;7(1):47–52; doi: 10.5114/pja.2020.93831.
 
18.
Pawliczak R. Sublingual immunotherapy and patient informed consent [in Polish]. Alergol Pol – Polish J Allergol. 2019;6(2):43–48; doi: 10.5114/pja.2019.86347.
 
19.
Bhansali S, Shafiq N, Malhotra S, Pandhi P, Singh I, Venkateshan SP, et al. Evaluation of the ability of clinical research participants to comprehend informed consent form. Contemp Clin Trials. 2009;30(5):427–430; doi: 10.1016/j.cct.2009.03.005.
 
20.
Kumar S, Mohanraj R, Rose A, Paul MJ, Thomas G. How ‘informed’ is informed consent? Findings from a study in South India. Indian J Med Ethics. 2012;9(3):180–186; doi: 10.20529/IJME.2012.061.
 
21.
Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Patients’ perceptions of written consent: questionnaire study. BMJ. 2006;333(7567):528; doi: 10.1136/bmj.38922.516204.55.
 
22.
Michie S, Lester K. Words matter: increasing the implementation of clinical guidelines. Qual Saf Health Care. 2005;14(5):367–370; doi: 10.1136/qshc.2005.014100.
 
23.
Pawliczak R. Immunotherapy and patient informed consent [in Polish]. Alergol Pol – Polish J Allergol. 2019;6(1):5–12; doi: 10.5114/pja.2019.84260.
 
24.
Miller VA. Parent-child collaborative decision making for the management of chronic illness: a qualitative analysis. Fam Syst Health. 2009;27(3):249–266; doi: 10.1037/a0017308.
 
25.
Nijhawan LP, Janodia MD, Muddukrishna BS, Bhat KM, Bairy KL, Udupa N, et al. Informed consent: issues and challenges. J Adv Pharm Technol Res. 2013;4(3):134–140; doi: 10.4103/2231-4040.116779.
 
26.
Ohmann C, Banzi R, Canham S, Battaglia S, Matei M, Ariyo C, et al. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open. 2017;7(12):e018647; doi: 10.1136/bmjopen-2017-018647.
 
ISSN:2544-4395
Journals System - logo
Scroll to top