| Objective To understand the experience of nursing researchers and research participants on informed consent process and propose improvement strategies based on the five-element theory of informed consent,so as to standardize the informed consent practice of nursing research,improve the ethical review system of nursing research,and better respect and protect the rights of research participants.Methods Purpose sampling,maximum variation sampling were adopted to select nursing researchers in universities or hospitals who are carrying out research projects or have conducted research projects within 6 months,and research participants who are participating in or have participated in their projects.The interview outline was formulated under the guidance of the five-element theory of informed consent.Face-to-face semi-structured personal interviews with nursing researchers and research participants were conducted.The data were analyzed by conventional content analysis and directed content analysis.Results 23 nursing researchers and 19 research participants were interviewed.After collating and summarizing the interview data of 23 nursing researchers,8 sections(including 21 themes and 2 sub-themes)were finally formed,they were:(1)Participants' motivation: including 2 themes of personal benefits and others benefits,where personal benefits including 2 sub-themes of regain physical health and meeting psychological needs;(2)Understanding of the purpose of informed consent: including3 themes of respecting participants,enabling research to proceed smoothly,protecting both researchers and participants;(3)disclosure content: including 5 themes of research nature,research benefits,voluntary participation,privacy protection,and research risks;(4)assessment of competency: including 3 themes of communication feedback-based,objective characteristics-based,and score of scale-based;(5)Participants' understanding: including 2 themes of insufficient understanding and sufficient understanding;(6)Voluntary of consent;including 2 themes of participants' self-determination and family participation in determining;(7)Views on the way of expressed consent: including 2 themes of verbal consent was more suitable for the participants and written consent was more in line with the ethical norms;(8)Feelings about informed consent process: including 2 themes of trust relationship and informed consent complementing each other,and research should provide participants with certain benefits.After collating and summarizing the interview data of 19 research participants,4 themes and 3 sub-themes were finally formed,they were:(1)Participation in research is beneficial and harmless: including 3 themes of personal benefit,others benefit,and harmless;(2)Lack of understanding on research information;(3)Having competence to make decisions autonomously;(4)Different views on the way of expressed consent.Conclusion Most nursing researchers are able to value and implement the principle of informed consent,and most research participants are able to treat the study correctly and make autonomous decisions.However,there are still many problems among informed consent of nursing research,including insufficient disclosure of information,incomplete assessment of competence,insufficient understanding of participants in research,conflicts between consent standards and practices.Researchers should provide participants with sufficient,accurate and comprehensive information to respect participants' right to be informed and self-determination;using scales to assess competence is a more comprehensive and effective method;researchers should adopt multiple strategies to improve participants' understanding;shared decision-making with family members should be encouraged to meet the best interests and value preferences of participants to the greatest extent;verbal consent and written consent are all have advantages and disadvantages,further researches should be carried out so as to find out other consent methods which are more consistent with nursing ethics in the future.In addition,support and trust are two key elements of informed consent.Researchers should provide participants with support within their capabilities and establish a good relationship of trust with participants. |
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