Question

Summarize below article 300 words no plagiarism. Thanks  INTRODUCTION Informed consent is a decision to participate...

Summarize below article 300 words no plagiarism. Thanks

 INTRODUCTION

Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation. Informed consent is a prerequisite for enrolling human subjects in biomedical research.

The concept of “Informed consent” was enshrined in the Nuremberg Code (1947) was reaffirmed in the 1964 Declaration of Helsinki and currently is one of the guiding principles for conduct in medical research.Informed consent in clinical research has two specific goals: to respect and promote a participant’s autonomy and to protect participants from harm.

A method to assess the quality of the informed consent in clinical research is by determining participants’ understanding of the information provided in the process of informed consent.5Understanding plays a significant role in research because it directly affects how ethical principles are applied in practice.

Research consent typically emphasizes disclosure on the presumption that more information aids potential participants in decision-making.However, some authors concluded that the investigation participants might frequently not understand the information provided by the researchers. Therefore in the last years, stakeholders tried to improve the informed consent process, by using multimedia tools and technologies or using quizzes that give immediate feedback. In Romania, the concept of informed consent in research is quite new, and it has not been grounded in the scientific society, less in the civic society.The literature review did not reveal studies conducted in Romania that investigates the participants’ understanding of the information provided by the researchers before enrolling them in biomedical research. Starting from this literature gap, we intend to study the understanding of the information provided by the researchers to the participants and the factors that may influence it.

This article explores the ethical challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. The objectives of the study research were: to analyze participant’s objective understanding of the information provided by the investigator before the start of the research procedures (e.g. do the participants understand the nature of the clinical trial?); to analyze participant’s subjective understanding of the information provided by the investigator prior to enrollment in the research study (e.g. do the participants think that they are well informed?); and to identify factors that could influence participant’s objective and subjective understanding.

This study used a quantitative survey design. Data was collected using a questionnaire in Romanian, the language spoken by the study participants. Twenty-nine (29) questions were asked of all participants, with an additional five questions asked of participants in phase II and III clinical trials. The questionnaire consists of two parts, with Part I assessing objective understanding and Part II assessing subjective understanding. The questionnaire was adapted from the Quality of Informed Consent (QuIC) scale first developed by Joffe et al.13and used with Prof. Joffe’s express permission.

In addition to the QuIC questions, socio-demographic data (age, gender, backgrounds, education, how many studies did the subject previously participate in) were also collected. The questionnaires were provided by the researcher during a face-to-face discussion with the study participants. Data were collected from two Research Centers from Iasi, Romania, between January and July 2016, and between November 2016 and February 2017.

The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The participants were split into two groups, one with 50 healthy volunteers recruited from a research center that conducts only phase I clinical trials and another with 50 cancer patients recruited from a research center that conducts phase II and III clinical trials. The researcher recruited participants after they signed the informed consent for their clinical trials.

Risks of participation in this study were small and consisted of a low level of discomfort that could appear because of the nature of the questions. To prevent this risk the researcher conducted the discussion in a non-critical manner, the participants weren’t rushed, and they received answers when they had questions, or they didn’t understand something. The questionnaire was anonymous. The researchers that ran the clinical trials didn’t have access to the positive or negative responses to the questionnaire, and the participation in the clinical trials wasn’t affected.

0 0
Add a comment Improve this question Transcribed image text
Answer #1

Informed consent is a agreement that the volunteer is ready to be participate in the research. Informed consent includes that the participant is ready , understands all the terms and condition and ready for the research.

All the consent consists of principles of ethics as participants must have authority as they can withdraw anytime from the research, there should be no anykind of harm to the participants.

Informed consent is a prerequisite for enrolling human subjects in biomedical research.

The concept of “Informed consent” was enshrined in the Nuremberg Code (1947) was reaffirmed in the 1964 Declaration of Helsinki and currently is one of the guiding principles for conduct in medical research.Informed consent in clinical research has two specific goals: to respect and promote a participant’s autonomy and to protect participants from harm.

Research consent typically emphasizes disclosure on the presumption that more information aids potential participants in decision-making.However, some authors concluded that the investigation participants might frequently not understand the information provided by the researchers. Therefore in the last years, stakeholders tried to improve the informed consent process, by using multimedia tools and technologies or using quizzes that give immediate feedback.

In the quantitative survey, 29 questions were asked from the participants.The questionnaire consists of two parts, with Part I assessing objective understanding and Part II assessing subjective understanding. The questionnaire was adapted from the Quality of Informed Consent (QuIC) scale first developed by Joffe et al.13and used with Prof. Joffe’s express permission.

Data were collected from two Research Centers from Iasi, Romania, between January and July 2016, and between November 2016 and February 2017.The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The participants were split into two groups, one with 50 healthy volunteers recruited from a research center that conducts only phase I clinical trials and another with 50 cancer patients recruited from a research center that conducts phase II and III clinical trials. The researcher recruited participants after they signed the informed consent for their clinical trials.

Risks of participation in this study were small and consisted of a low level of discomfort that could appear because of the nature of the questions. To prevent this risk the researcher conducted the discussion in a non-critical manner, the participants weren’t rushed, and they received answers when they had questions, or they didn’t understand something.

Add a comment
Know the answer?
Add Answer to:
Summarize below article 300 words no plagiarism. Thanks  INTRODUCTION Informed consent is a decision to participate...
Your Answer:

Post as a guest

Your Name:

What's your source?

Earn Coins

Coins can be redeemed for fabulous gifts.

Not the answer you're looking for? Ask your own homework help question. Our experts will answer your question WITHIN MINUTES for Free.
Similar Homework Help Questions
  • 61 2.2 Waived Consent in a Breast Cancer Trial In the case below, British researchers persuaded...

    61 2.2 Waived Consent in a Breast Cancer Trial In the case below, British researchers persuaded an ethics committee that a particular trial should not involve informed consent because the information to be comveyed in that process would be hurtful to the subjects. However, a subject learned later that she had been involved in the trial without her knowledge or consent. This disclo sure opens the question of whether informed consent should ever be waived and, if so, whether justifications...

  • First, read the article on "The Delphi Method for Graduate Research." ------ Article is posted below...

    First, read the article on "The Delphi Method for Graduate Research." ------ Article is posted below Include each of the following in your answer (if applicable – explain in a paragraph) Research problem: what do you want to solve using Delphi? Sample: who will participate and why? (answer in 5 -10 sentences) Round one questionnaire: include 5 hypothetical questions you would like to ask Discuss: what are possible outcomes of the findings from your study? Hint: this is the conclusion....

  • Use the this tool to critique the article Screening Questions Can't tell No 1. Was there...

    Use the this tool to critique the article Screening Questions Can't tell No 1. Was there a clear statement of the aims of the research? Whet was "he geal of the 'esearch? Why it was thought inportant? hs relevanoe · 。YesOcan't tell。No 2. Is a qualitative methodology appropriate? HINT: Consider If the research seeks to interpret or iluminate the actions and/or subjective expariences of neseanch Is qualitative research the right methodolagy for addressing the research ? Is it worth continuing?...

  • Clinical trial The design of the clinical trial for this study represented a single centered, double...

    Clinical trial The design of the clinical trial for this study represented a single centered, double blind, placebo-controlled trial that utilized randomization to target patients for the trial. The eligible patients for the study were aged 21-90 years and after receiving a biopsy, these patients had confirmed colorectal adenocarcinoma and were deemed eligible for receiving treatment for the surgery to remove their adenocarcinoma, but were instead given an opportunity to participate in this research trial with written informed consent. Potential...

  • I need help with research critique summary of this below article in APA format and in...

    I need help with research critique summary of this below article in APA format and in text citation and the reference en/poni%20perception%20article.pdf EATING DISORDERS 2018, VOL. 26, NO. 2, 107-126 https://doi.org/10.1080/10640266,2017.1318624 Routledge Taylor & Francis Group PREVENTION SERIES Check to Perceptions of disordered eating and associated help seeking in young women Annamaria J. McAndrew and Rosanne Menna Department of Psychology, University of Windsor, Windsor, Ontario, Canada ABSTRACT Disordered eating is common among young women, but rates of help-seeking are remarkably...

  • Directions What is a research proposal? The purpose of a research proposal is to identify and...

    Directions What is a research proposal? The purpose of a research proposal is to identify and formulate questions that arise from nursing practice and to design a research project to study the identified problem. The goal of a research proposal is to present and justify a research idea you have and to present the practical ways in which you think this research should be conducted. Research proposals contain extensive literature reviews and must provide persuasive evidence that there is a...

  • Summarize the following information in easily way and in simple words as your understanding without missing the keywords. ( the Question will be 25 on this information in final ) MARKETING RESEARCH FO...

    Summarize the following information in easily way and in simple words as your understanding without missing the keywords. ( the Question will be 25 on this information in final ) MARKETING RESEARCH FOR THE NEW VENTURE Information for developing the marketing plan may necessitate conducting some marketing research. Marketing research involves the gathering of data to determine such information as who will buy the product or service, what is the size of the potential market, what price should be charged,...

  • en in placebo-cont outweigh any sons for your answers ntrolled trials. Would the virus are unavailable...

    en in placebo-cont outweigh any sons for your answers ntrolled trials. Would the virus are unavailable bjections to such trials? and are not included in Cornell's promise to pr rticular vulner Chapter& Human Researeh 35s except to the very wealthy only very usceptible he said in an i medicine Nea to Test Drugs on Children Hasten , http:/www.nytines.com/ooolog/ta/ o years after Cornell opened the clinic, es some of the best AIDS treatment avail- s a country devastated by the epidemic,...

  • Read the article, more specifically the abstract, introduction, discussion and conlcusion and summarize those specific sections...

    Read the article, more specifically the abstract, introduction, discussion and conlcusion and summarize those specific sections in a paragraph or two. INTRODUCTION With the increase in recreational and competitive cycling, cyclists are experiencing more overuse inju- ries related to repetitive loading.Both intrinsic and extrinsic factors contribute to injury. Intrinsic fac- tors are inherent to the cyclist and include fitness level as well as anatomical alignment of the lower extremities. Extrinsic factors are generally asso- ciated with factors external to the...

  • Article Summary I Read the article below and provide feedback by writing a 2 page summary....

    Article Summary I Read the article below and provide feedback by writing a 2 page summary. Please write in essay format (you may include the questions but the response should be in essay format) Must include the following information Title of the article Author(s) of the article Reference list (include the article itself and any other reference material such as another article that is cited in your summary). Use the reference list in the article to get information about another...

ADVERTISEMENT
Free Homework Help App
Download From Google Play
Scan Your Homework
to Get Instant Free Answers
Need Online Homework Help?
Ask a Question
Get Answers For Free
Most questions answered within 3 hours.
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT