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REVIEW ARTICLE
Year : 2013  |  Volume : 4  |  Issue : 3  |  Page : 134-140  

Informed consent: Issues and challenges

Lokesh P Nijhawan1, Manthan D Janodia2, BS Muddukrishna3, KM Bhat3, KL Bairy4, N Udupa2, Prashant B Musmade3
1 Department of Advanced Pharmaceutical Studies, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
2 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
3 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
4 Department of Pharmaceutical Quality Assurance, Kasturba Medical College, Manipal University, Manipal, Karnataka, India

Date of Web Publication21-Aug-2013

Correspondence Address:
Prashant B Musmade
Manipal College of Pharmaceutical Sciences, Manipal University, Manipal - 576 104, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2231-4040.116779

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  Abstract 

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.

Keywords: Human subjects, informed consent, institutional review board


How to cite this article:
Nijhawan LP, Janodia MD, Muddukrishna B S, Bhat K M, Bairy K L, Udupa N, Musmade PB. Informed consent: Issues and challenges. J Adv Pharm Technol Res 2013;4:134-40

How to cite this URL:
Nijhawan LP, Janodia MD, Muddukrishna B S, Bhat K M, Bairy K L, Udupa N, Musmade PB. Informed consent: Issues and challenges. J Adv Pharm Technol Res [serial online] 2013 [cited 2022 May 19];4:134-40. Available from: https://www.japtr.org/text.asp?2013/4/3/134/116779


  Introduction Top


For a drug to get approved and enter into the market it has to prove its safety and efficacy in clinical trials. Clinical trial is a term used to describe all research related activities, which use human being as subjects. As no individual has right to infract fundamental rights of another person for the sake of fulfilling his own purpose, so an important tool called "informed consent" came into existence.

The informed consent is described in ethical codes and regulations for human subject's research. The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding "to" or "not to" participate in the research study.

Conventionally informed consent is thought to be in terms of the documents signed and dated by participants, setting forth the purpose, benefits, risks and other study information necessary to allow the participants to make an informed and voluntary decision to participate in the clinical study. In reality, informed consent is the process that applies to each communication to participants, commencing with the subject recruitment material and the initial telephone screening of potential subjects through the conclusion of the study. It also describes the obligation of the investigator to inform the subject about personal benefits and risk, individual faces in study.

Informed consent is not only required for clinical trials but is an essential prerequisite before enrolling each and every participant in any type of research involving human subjects including; diagnostic, therapeutic, interventional, bioequivalence, social and behavioral studies and for all research conducted domestically or abroad. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, the procedures to be undergone, the potential risks and/or benefits of participation and alternative treatments available if any. Subjects in the study must participate willingly only after consenting based on the information given. [1],[2],[3]


  The Origins of Informed Consent Top


Informed consent is a central tenet of research ethics involving human beings and has evolved into present shape over a period of time. The journey of informed consent is briefly described below [Table 1], [Table 2] and [Table 3]. [4],[5],[6],[7]
Table 1: Evolution of informed consent

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Table 2: Classification of informed consent

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Table 3: Informed consent and obligations

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  Basic Elements for Written Informed Consent Documents Top


  1. A statement that the study involves research;
  2. An explanation of the purpose of research and the expected duration of the subject's participation;
  3. A description of the procedures to be followed and identification of any procedures that are experimental;
  4. A description of any foreseeable risks or discomforts to the subject, an estimate of their likelihood and a description of what steps will be taken to prevent or minimize them;
  5. A description of any benefits to the subject or to others that may reasonably be expected from the research. Monetary compensation is not a benefit;
  6. A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the subject;
  7. A statement describing to what extent records will be kept confidential, including a description of who may have access to research records;
  8. For research involving more than minimal risk, an explanation and description of any compensation and any medical treatments that are available if research subjects are injured; where further information may be obtained and whom to contact in the event of a research-related injury;
  9. Information on the amount of remuneration/compensation, if any, that will be provided to subjects;
  10. An explanation of whom to contact for answers to pertinent questions about the research and the research subject's rights (include the clinical center's patient representative and telephone number);
  11. A statement that participation is voluntary and that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled. [13]

  Requirements for Obtaining Informed Consent Top


  1. The investigator or a person designated by investigator must obtain informed consent
  2. Informed consent must be obtained before non-routine screening procedures are performed and/or before any change in the subject's current medical therapy is made for the purpose of the clinical trial
  3. The subject/subject's legally acceptable representative should not be forced to sign on consent or participate/continue to participate in the trial
  4. The subject/legally acceptable representative and individual obtaining consent must personally sign with date the form. The signature of the prospective subject/legally acceptable representative on informed consent document indicated that content of informed consent document has been adequately discussed and the subject/subject's legally acceptable representative freely gave the informed consent [Figure 1]. [13]
    Figure 1: Flow chart regarding various informed consent processes

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  Informed Consent Process Flow Top


Notes to Flowchart

  1. Source documents must reflect that consent was obtained before the start of study treatment and procedures
  2. A copy of the signed consent form must be kept at the site
  3. All versions of approved consent forms must be kept in the site study file; only the current Institutional Review Board (IRB) approved version may be used to consent new patients. [14]

  Waivers to Informed Consent Top


  1. A waiver of informed consent under 45 Code of Federal Regulations (CFR) 46.116 (d)
  2. An alteration of consent under 45 CFR 46.116 (d)

    An IRB may waive the requirements to obtain informed consent provided the IRB finds and documents that:
    • The research involves no more than minimal risk to the subjects;
    • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
    • The research could not practicably be carried out without the waiver or alteration and
    • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
  3. A waiver of parent/guardian permission under 45CFR 46.408 (c)
  4. A waiver of assent under 45 CFR 46.408 because the minors are not capable of assent
  5. A waiver of assent under 45 CFR 46.408 because the research holds out a prospect of direct benefit that is available only in the context of the research. [15]



  Challenges in Informed Consent Process Top


Language Barriers

It is assumed that the individual who signs the consent form does so with full understanding of what is stated on the consent form. However, it is very difficult to evaluate their viewpoint about trial since there is no established method to measure the level of understanding that a participant has about the information given. Thus, it can be assumed that there is a degree of misunderstanding that occurs. Misunderstandings can occur because of incorrect or inadequate language translations. Many individuals sign the consent form without being fully aware of what they are signing, which results in withdrawal of subject at later stages of ongoing clinical studies. Hence, the responsibility of researcher enlarges when a study is performed in multilingual subjects [Table 4]. [16]
Table 4: Barriers to participation in clinical trials

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Religious Influence

The informed consent process is designed to give every participant the liberty to decide whether to accept or refuse the recommended medical treatment. Sometimes their decision for participating in researcher projects is influenced by the religious beliefs. It is commonly observed that how the methodology of the experiment come into conflict with the rules of behavior set by a participant's religion. [17],[18]

False Expectations

Even when there are no language barriers or religious impediments to hinder the communication relationship between researcher and participant, misunderstanding can still occur due to participants false expectations of the experiment outcome. Some patient fear of being treated as mere "experimental model" for the studies while others refuse to take part because of historical evidences of clinical trial fraud and misconducts known to them. [17],[18]

Patient Perceptions

Most patients believe that, trials will put extra burden on them. They assume that the conventional treatment is best and they are afraid of the unknown side-effects of new treatment. Convincing and receiving an informed consent from such patient is most difficult. In some case disclosing too much information of the potential side-effects may unnecessarily scare the patient away from a potentially life-saving or life-enhancing surgery or procedure. [17],[18]

Children

Where research involves children (under the age of 18) consent/permission has to be obtained from parents. If the child is above 7 years of age then "child assent" is also mandatory. It is arguable that children are capable of being partners in research and that they have rights to receive information, to be listened to, have their wishes and feelings taken into account and to give or withhold consent if judged competent to do so. Difficulty arises when parents give their consent while child refuses to assent. [20]

Vulnerable People and Groups

Vulnerable groups include the person who is absolutely or relatively incapable of protecting their interests. Obtaining informed consent is critical when working with them, specifically with some groups like people with learning disabilities. There may be potential problems of understanding what the research is about, what their role in the research will be and how the research will be used. Hence, obtaining informed consent can be difficult and special care needs to be taken to develop the appropriate strategies for communicating the implications of involvement in research. [21],[22]

Indian Scenario

In countries like India, the clinical investigations are based on regional values and practices, the concept of disease as perceived through social values and power hierarchies in family of villages based on cultural systems. To get a meaningful and ethical informed consent in these settings become challenging due to differences in cultural values in western countries and local customs in developing countries including India. In a study by DeCosta et al. [23] that was carried out in a village of Haryana state of India, the majority of respondents interviewed by them could decide on clinical trial participation after discussing with community members. Another important factor emerged from this study, which showed an implicit trust by respondents in the medical system and ignorance about the information that should be known before consenting to be a part of the research study. These factors put a huge responsibility on the part of the investigator to get informed consent. The investigator must explain in most comprehensive and complete manner the risks involved in participating in the research study. Thus, investigator should have the patience to get informed consent from these subjects allowing them to discuss with other family and community members. The ethical principles of western countries require all adults to be the primary decision makers of their participation, which may not be applicable in Indian system, which is culturally and socially different from the western world. [23] Another important aspect of informed consent arises in psychiatric clinical studies. As large numbers of psychiatry studies are conducted in India, these studies present complex and unique challenges in Indian context. These issues include risk of worsening of illness, use of placebo and validity of informed consent. The informed consent procedure requires patient to be of sound mind and in understanding the information presented and make a sound judgment regarding participation. Assessment of consent capacity may be difficult due to fluctuation in illness, which requires continued assessment of consent capacity. Thus, conducting clinical trials and obtaining informed consent for psychiatry studies is difficult and raises a doubt on the conduct of clinical trials due to lack of trained researchers. The guidelines are prepared keeping in mind the western culture and may not replicate the same results due to cultural variability in non-western countries like India. [24] The dilemma in obtaining informed consent from subjects with cognitive impairment includes validity of informed consent by subject, implications and validity of third party consent, protection of human subjects. Regulations don't provide information and guidance on ethical issues of psychiatry research. [25]


  Conclusion Top


Though enveloped by challenges, informed consent is an important tool in clinical trials, which facilitates the entry of new therapeutic interventions into the market. No research activity involving human subjects can be conducted and proceed unless informed consent is completely sought. The responsibility of conducting trial ethically and genuinely lies in the hands of those involved in it. Everyone must understand their obligations and should not misuse their power for own benefit. Rights, safety and well-being of trial subjects should always prevail over the interest of science and society, so that a layman never feels being deceived off in name of a social cause. The issue of informed consent in India is a challenge on the part of investigator as a lot of complexities arise. Further, regulations are based on the western guidelines, which do not necessarily reflect the requirements of India. The guidelines on informed consent in India should be based on complex factors such as culture, level of education, demographics and risks involved during the study.

 
  References Top

1.International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Guideline for good clinical practice E6(R1) June 1996. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf. [Last accessed on 2011 Apr 19].  Back to cited text no. 1
    
2.Berry IR. The Pharmaceutical Regulatory Process. New York: Marcel Dekker; 2005.  Back to cited text no. 2
    
3.Lee C, Lee LH, Wu CL, Lee BR, Chen ML. Clinical Trials of Drugs and Biopharmaceuticals. Florida: CRC Press, Taylor and Francis Groups; 2006.  Back to cited text no. 3
    
4.The Nuremberg code (1947). Br Med J 1996;313:1448. Available from: http://www.cirp.org/library/ethics/nuremberg/. [Last accessed on 2011 Apr 19].  Back to cited text no. 4
    
5.World Medical Association declaration of Helsinki. Ethical principles for medical research involving human subjects. Available from: http://www.ohsr.od.nih.gov/guidelines/helsinki.html. [Last accessed on 2011 Apr 20].  Back to cited text no. 5
    
6.The Belmont Report ethical principles and guidelines for the protection of human subjects of research. The National Commission for the protection of human subjects of biomedical and behavioral research; April 18, 1979. Available from: http://www.ohsr.od.nih.gov/guidelines/belmont.html. [Last accessed on 2011 Apr 20].  Back to cited text no. 6
    
7.International ethical guidelines for biomedical research. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), Geneva, 2002. Available from: http://www.nccr.gov.my/index.cfm?menuid=23 and parentid=17. [Last accessed on 2011 Apr 20].  Back to cited text no. 7
    
8.Research involving children under the age of 18. Available from: http://www.belmont.edu/irb/instructions/Consent.html#Children. [Last accessed on 2011 Apr 20].  Back to cited text no. 8
    
9.CFR-Code of Federal Regulations Title 21; Part 50-Protection of Human Subjects. Short form written consent document. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.27. [Last accessed on 2011 Apr 21].  Back to cited text no. 9
    
10.Investigator responsibilities-Protecting the rights, safety, and welfare of study subjects 2009 October. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf. [Last accessed on 2011 Apr 21].  Back to cited text no. 10
    
11.Informed consent. Available from: http://www.hhs.gov/ohrp/archive/irb/irb_chapter 3.htm#e2. [Last accessed on 2011 Apr 22].  Back to cited text no. 11
    
12.Niazi SK. Handbook of Bioequivalence Testing. USA: Informa Healthcare; 2007.  Back to cited text no. 12
    
13.Guidelines for writing informed consent documents. OHSR Information Sheets/Forms 2006 December. Available from: http://www.ohsr.od.nih.gov/info/sheet6.html. [Last accessed on 2011 Apr 26].  Back to cited text no. 13
    
14.Informed Consent Process Flow. Available from: http://www.ctnbestpractices.org/resources/study-patient-management/informed-consent/Informed_Consent_Process.pdf/view. [Last accessed on 2011 Apr 27].  Back to cited text no. 14
    
15.Waiver of Informed Consent. Available from http://www.irb.purdue.edu/waiveconsent.shtml. [Last accessed on 2011 Apr 29].  Back to cited text no. 15
    
16.Escobedo C, Guerrero J, Lujan G, Ramirez A, Serrano D. Ethical Issues with Informed Consent. Available from: http://www.cstep.cs.utep.edu/research/ezine/EzineEthicalIssueswithInformedConsent.pdf. [Last accessed on 2011 Apr 29].  Back to cited text no. 16
    
17.Jehovah′s Witness ethics 2009 September 29. Available from: http://www.bbc.co.uk/religion/religions/witnesses/witnessethics/ethics_1.shtml. [Last accessed on 2011 Apr 30].  Back to cited text no. 17
    
18.Jehovah′s Witnesses and Blood Transfusions. Available from: http://www.jwfacts.com/watchtower/blood-transfusions.php. [Last accessed on 2011 May 2].  Back to cited text no. 18
    
19.Gonzalez LE, Quinn GP, McIntyre J. Main Barriers to Participation. Available from: http://www.kon.org/urc/v9/gonzalez.html. [Last accessed on 2011 May 4].  Back to cited text no. 19
    
20.Child Assent Requirement 2010 January. Available from: http://www.nhlbi.nih.gov/childrenandclinicalstudies/terms_assent.php. [Last accessed on 2011 May 6].  Back to cited text no. 20
    
21.Ethical Principles for Researching Vulnerable Groups 2003 May. Available from: http://www.ofmdfmni.gov.uk/ethicalprinciples.pdf. [Last accessed on 2011 May 7].  Back to cited text no. 21
    
22.Levine RJ. The Ethics and Regulation of Clinical Research. Michigan: Urban and Schwarzenberg; 1981.  Back to cited text no. 22
    
23.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;30:318-23.  Back to cited text no. 23
[PUBMED]    
24.Kharawala S, Dalal J. Challenges in conducting psychiatry studies in India. Perspect Clin Res 2011;2:8-12.  Back to cited text no. 24
[PUBMED]  Medknow Journal  
25.Gupta UC, Kharawala S. Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations. Perspect Clin Res 2012;3:8-15.  Back to cited text no. 25
[PUBMED]  Medknow Journal  


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]


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[Pubmed] | [DOI]
38 Landslide exposure awareness: a community-based approach towards the engagement of children
Noemi S. Ruiz-Cortés,Irasema Alcántara-Ayala
Landslides. 2020;
[Pubmed] | [DOI]
39 Perceptions of South Africans on traditional leadership: a case of Limpopo Province
Mavhungu Elias Musitha
African Identities. 2020; : 1
[Pubmed] | [DOI]
40 Experiences and reactions of adolescent offspring to their fathers’ heavy drinking: A qualitative study from an urban metropolis in India
Prasanthi Nattala,Pratima Murthy,Mitchell G. Weiss,Kit Sang Leung,Rita Christopher,Jessy Sharoon V,Sumegha S
Journal of Ethnicity in Substance Abuse. 2020; : 1
[Pubmed] | [DOI]
41 Key components and IT assistance of participant management in clinical research: a scoping review
Johannes Pung,Otto Rienhoff
JAMIA Open. 2020;
[Pubmed] | [DOI]
42 Ethical challenges of obtaining informed consent from surgical patients
Sanaz Moeini,Mohsen Shahriari,Mahdi Shamali
Nursing Ethics. 2020; 27(2): 527
[Pubmed] | [DOI]
43 Supportive effect of body contact care with ylang ylang aromatherapy and mobile intervention team for suicide prevention: A pilot study
Stéphane Amadéo, Ngoc Lam Nguyen, Taivini Teai, Patrick Favro, Aurélia Mulet, Nathalie Colin-Fagotin, Moerani Rereao, Aurélia Malogne, Michel De Simone, Géraldine Rioche, Virginie Gassion, Paul Pere, Alban Prokop, Fabienne Bernis, Pierre Dufour, Annie Tuheiava, Germaine Vanquin, Steve Vilhem, Erick Gokalsing, Michel Spodenkiewicz, Marianne Pradem, Monique Seguin, Guy Beauchamp, Pierre Thomas, Guillaume Vaiva, Louis Jehel
Journal of International Medical Research. 2020; 48(9): 0300060520
[Pubmed] | [DOI]
44 Glossary for randomized clinical trials
V. Nagendrababu,H. F. Duncan,S. J. Pulikkotil,P. M. H. Dummer
International Endodontic Journal. 2020;
[Pubmed] | [DOI]
45 Contraceptive Autonomy: Conceptions and Measurement of a Novel Family Planning Indicator
Leigh Senderowicz
Studies in Family Planning. 2020;
[Pubmed] | [DOI]
46 Nothing to lose: a grounded theory study of patients’ and healthcare professionals’ perspectives of being involved in the consent process for oncology trials with non-curative intent
Mary Murphy,Eilís McCaughan,Matthew A Carson,Monica Donovan,Richard H Wilson,Donna Fitzsimons
BMC Palliative Care. 2020; 19(1)
[Pubmed] | [DOI]
47 Fostering ethical biomedical and health research in India during the COVID-19 pandemic
Nandini K Kumar,Vasantha Muthuswamy
Research Ethics. 2020; 16(3-4): 1
[Pubmed] | [DOI]
48

Informed Consent Form Challenges for Genetic Research in Jordan
Almuthanna K Alkaraki,Omar F Khabour,Karem H Alzoubi,Lina M K Al-Ebbini,Zaid Altaany
Journal of Multidisciplinary Healthcare. 2020; Volume 13: 235
[Pubmed] | [DOI]
49 Understanding voluntariness of consent in first-in-human cell therapy trials
Kristina Hug
Regenerative Medicine. 2020;
[Pubmed] | [DOI]
50 Identification of factors that influence occupational accidents in the petroleum industry: A qualitative approach
Zahra Naghavi Konjin,Seyed Bagher Mortazavi,Hassan Asilian Mahabadi,Ebrahim Hajizadeh
Work. 2020; : 1
[Pubmed] | [DOI]
51 Using patient and public involvement to improve the clinical pathway for participants in clinical trials
Ben Hood
Cancer Nursing Practice. 2020;
[Pubmed] | [DOI]
52 Informed Consent in the Newly Established Biobank
Judita Kinkorová,Ondrej Topolcan,Radek Kucera
International Journal of Environmental Research and Public Health. 2019; 16(20): 3943
[Pubmed] | [DOI]
53 Biology Teachers’ Worldviews on the Global Distribution and Loss of Biodiversity: A GIS-Based Mental-Mapping Approach
Florian Fiebelkorn,Susanne Menzel
Frontiers in Psychology. 2019; 10
[Pubmed] | [DOI]
54 Can a Like Save the Planet? Comparing Antecedents of and Correlations Between Environmental Liking on Social Media, Money Donation, and Volunteering
Alexander Georg Büssing,Annelene Thielking,Susanne Menzel
Frontiers in Psychology. 2019; 10
[Pubmed] | [DOI]
55 Perspectives concerning the law on Advance Directives and Advance Care Planning and their effects on end-of-life care in Italian Intensive Care Units
Gilda Cinnella,Claudio Lo Presti
Minerva Anestesiologica. 2019; 85(4)
[Pubmed] | [DOI]
56 A Review of Clinical Data Management Systems Used in Clinical Trials
Aynaz Nourani,Haleh Ayatollahi,Masoud Solaymani Dodaran
Reviews on Recent Clinical Trials. 2019; 14(1): 10
[Pubmed] | [DOI]
57 Awareness and opinions of research professionals about Indiaæs new drugs and clinical trials regulations: Protocol for a cross-sectional online survey (Preprint)
Vishal Vennu,Saurabh Dahiya
JMIR Research Protocols. 2019;
[Pubmed] | [DOI]
58 Why did I stop? And why did I restart? Perspectives of women lost to follow-up in option B+ HIV care in Dar es Salaam, Tanzania
Adellah Sariah,Joan Rugemalila,Joyce Protas,Eric Aris,Helen Siril,Edith Tarimo,David Urassa
BMC Public Health. 2019; 19(1)
[Pubmed] | [DOI]
59 Designing AI for Social Good: Seven Essential Factors
Josh Cowls,Thomas King,Mariarosaria Taddeo,Luciano Floridi
SSRN Electronic Journal. 2019;
[Pubmed] | [DOI]
60 Ethical issues in consenting older adults: academic researchers and community perspectives
Shoroq M. Altawalbeh,Fadi M. Alkhateeb,Omar F. Attarabeen
Journal of Pharmaceutical Health Services Research. 2019;
[Pubmed] | [DOI]
61 Encouraging managers of care homes for older adults to participate in research
Nick Smith,Ann-Marie Towers,Grace Collins,Sinead Palmer,Stephen Allan,Jennifer Beecham
Quality in Ageing and Older Adults. 2019; 20(3): 120
[Pubmed] | [DOI]
62 Difficulties and challenges in the development of precision medicine
Xiaoqin Liu,Xin Luo,Chunyang Jiang,Hui Zhao
Clinical Genetics. 2019;
[Pubmed] | [DOI]
63 Promoting informed consent in a children's hospital in Tabriz, Iran
Neda Kabiri,Sakineh Hajebrahimi,Gisoo Alizadeh,Solmaz Azimzadeh,Nayyereh Farajzadeh,Amin Talebpour
JBI Database of Systematic Reviews and Implementation Reports. 2019; 17(12): 2570
[Pubmed] | [DOI]
64 Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation
Rajesh Ranjan,Nidhi B. Agarwal,Prem Kapur,Amit Marwah,Rizwana Parveen
Asia Pacific Journal of Public Health. 2019; 31(8): 710
[Pubmed] | [DOI]
65 The Difficult to Access “Right-To-Try” U.S. Health Care Law
Douglas Van Nostrand
Clinical Thyroidology. 2019; 31(1): 33
[Pubmed] | [DOI]
66 Occupational health research beyond the work setting: inclusive inquiry with ethnic minority and immigrant workers
Marie-Anne S. Rosemberg,Doris M. Boutain,Jenny Hsin-Chun Tsai
Ethnicity & Health. 2019; : 1
[Pubmed] | [DOI]
67 Confidentiality, power relations and evaluation of potential harm in the study of the personal and organizational networks of travel agents in Moscow
Isidro Maya-Jariego,Deniza Alieva,Daniel Holgado
Social Networks. 2019;
[Pubmed] | [DOI]
68 Room for Improvement
Ryan S. DæSouza,Rebecca L. Johnson,Layne Bettini,Phillip J. Schulte,Christopher Burkle
Mayo Clinic Proceedings. 2019; 94(9): 1786
[Pubmed] | [DOI]
69 Dematerialisation of patient’s informed consent in radiology: insights on current status and radiologists’ opinion from an Italian online survey
Francesca Coppola,Lorenzo Faggioni,Roberto Grassi,Corrado Bibbolino,Agatina Rizzo,Nicoletta Gandolfo,Antonella Calvisi,Carlo Alberto Cametti,Giorgio Benea,Andrea Giovagnoni,Carmelo Privitera,Daniele Regge
La radiologia medica. 2019;
[Pubmed] | [DOI]
70 Impact of informed consent content and length on recruitment of older adults into a community based primary prevention trial
Fleur OæHare,Simone Spark,Zachary Flanagan,Stephane Heritier,Andrea Curtis,Sophia Zoungas
Contemporary Clinical Trials Communications. 2018; 11: 89
[Pubmed] | [DOI]
71 Informed consent comprehension among vulnerable populations in Ecuador: video-delivered vs. in-person standard method
Ana Quevedo,Cecilia Condo,Gilda Valenzuela,Lucy Molina,Eduardo Castillo,Ana Palacio,Denisse Pareja,Guillermo Prado,Yannine Estrada,Maria Rosa Velazquez,Leonardo Tamariz
Accountability in Research. 2018; : 1
[Pubmed] | [DOI]
72 Informed consent learning: Needs and preferences in medical clerkship environments
Tahra AlMahmoud,M. Jawad Hashim,Rabah Almahmoud,Frank Branicki,Margaret Elzubeir,Iratxe Puebla
PLOS ONE. 2018; 13(10): e0202466
[Pubmed] | [DOI]
73 The Question of Whether Orthopaedic Surgeons Should Delegate Informed Consent to PAs and NPs
Vasco Deon Kidd
JBJS Journal of Orthopaedics for Physician Assistants. 2018; 6(3): e28
[Pubmed] | [DOI]
74 Consentimiento informado en la discapacidad: trastorno del espectro autista
Beatriz Sanabria Barradas,Pascual Linares Márquez,Dora Elizabeth Granados Ramos
Revista Latinoamericana de Bioética. 2018; 19(36-1): 11
[Pubmed] | [DOI]
75 Assessment of the Right-to-Try Law: The Pros and the Cons
Brandon Brown,Camerin Ortiz,Karine Dubé
Journal of Nuclear Medicine. 2018; 59(10): 1492
[Pubmed] | [DOI]
76 Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience
Robyn Fossey,David Kochan,Erin Winkler,Joel Pacyna,Janet Olson,Stephen Thibodeau,John Connolly,Margaret Harr,Meckenzie Behr,Cynthia Prows,Beth Cobb,Melanie Myers,Nancy Leslie,Bahram Namjou-Khales,Hila Milo Rasouly,Julia Wynn,Alexander Fedotov,Wendy Chung,Ali Gharavi,Janet Williams,Lynn Pais,Ingrid Holm,Sharon Aufox,Maureen Smith,Aaron Scrol,Kathleen Leppig,Gail Jarvik,Georgia Wiesner,Rongling Li,Mary Stroud,Jordan Smoller,Richard Sharp,Iftikhar Kullo
Journal of Personalized Medicine. 2018; 8(1): 2
[Pubmed] | [DOI]
77 Gender Attitudes in Religious Schools: A Comparative Study of Religious and Secular Private Schools in Guatemala
Darin Mather
Religions. 2018; 9(7): 219
[Pubmed] | [DOI]
78 Organ dose variability and trends in tomosynthesis and radiography
Jocelyn Hoye,Yakun Zhang,Greeshma Agasthya,Greg Sturgeon,Anuj Kapadia,W. Paul Segars,Ehsan Samei
Journal of Medical Imaging. 2017; 4(3): 031207
[Pubmed] | [DOI]
79 Awareness and beliefs about alcohol use among women in India
Kanika Malik,Prabhat K. Chand,P. Marimuthu,L. N. Suman
International Journal of Culture and Mental Health. 2017; : 1
[Pubmed] | [DOI]
80 Does Kangaroo care affect the weight of preterm/low birth-weight infants in the neonatal setting of a hospital environment?
Colette Cunningham,Zena Moore,D. Patton,T. OæConnor,Linda E. Nugent
Journal of Neonatal Nursing. 2017;
[Pubmed] | [DOI]
81 Ensayos clínicos y consentimiento informado: visión de investigadores, pacientes y médicos de familia
Nuria Giménez,David Pedrazas,Susana Redondo,Salvador Quintana
Atención Primaria. 2016;
[Pubmed] | [DOI]
82 Prevalence and Characteristics of CAM Use among People Living with HIV and AIDS in Lebanon: Implications for Patient Care
Joana Abou-Rizk,Mohamad Alameddine,Farah Naja
Evidence-Based Complementary and Alternative Medicine. 2016; 2016: 1
[Pubmed] | [DOI]
83 Postal recruitment and consent obtainment from index cases of narcolepsy
Gambo Aliyu,Salah M. Mahmud
BMC Medical Ethics. 2016; 17(1)
[Pubmed] | [DOI]
84 Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study
Serebe Abay,Adamu Addissie,Gail Davey,Bobbie Farsides,Thomas Addissie,Ute Vollmer-Conna
PLOS ONE. 2016; 11(6): e0157056
[Pubmed] | [DOI]
85 Recruiting to Clinical Trials on the Telephone – a randomized controlled trial
Kim Thestrup Foss,Jesper Kjærgaard,Lone Graff Stensballe,Gorm Greisen
Trials. 2016; 17(1)
[Pubmed] | [DOI]
86 Ethical threats and safeguards: Principles for rehabilitation research
Brenda Morrow
International Journal of Therapy and Rehabilitation. 2015; 22(11): 506
[Pubmed] | [DOI]
87 Informed consent in paediatric critical care research – a South African perspective
Brenda M. Morrow,Andrew C. Argent,Sharon Kling
BMC Medical Ethics. 2015; 16(1)
[Pubmed] | [DOI]
88 Community perceptions and beliefs of blood draws for clinical trials conducted in Africa and their management: a systematic review of qualitative evidence protocol
George Adjei,Yeetey Enuameh
JBI Database of Systematic Reviews and Implementation Reports. 2015; 13(6): 27
[Pubmed] | [DOI]
89 The Revised World Medical Associationæs Declaration of Helsinki 2013: Enhancing the Protection of Human Research Subjects and Empowering Ethics Review Committees
Arnauld Nicogossian,Otmar Kloiber,Bonnie Stabile
World Medical & Health Policy. 2014; 6(1): 1
[Pubmed] | [DOI]
90 Elements for Adequate Informed Consent in the Surgical Context
Hernando Abaunza,Klaus Romero
World Journal of Surgery. 2014;
[Pubmed] | [DOI]



 
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