Research: Ethical Considerations


Principle


Content


Honesty


• A researcher must be honest in the proposing, planning, performing, and reporting of research


• A researcher must honestly describe the research contribution and disclose any potential conflicts of interest


• Fabrication, falsification, and misrepresentation are not allowed in scientific communication


Objectivity


• The researcher needs to be free from external influences such as personal interest, value commitments, or community bias


• A researcher should strive for objectivity in research design, data analysis and interpretation and publication


• Science will never be completely free from political, social, cultural, or economic influences


Carefulness


• Research should be conducted in a precise manner to avoid mistakes and errors


• Researchers should critically examine their own work as well as the research of peers


• Researchers must avoid self-deception, bias, and conflicts of interest


• All research activities, such as consent forms, data collection, and data analysis should be well documented.


Fair credit


• Researchers must ensure the fair allocation of research credit, for example, authorship credit in publications, patents and other materials


Openness


• Openness promotes the advancement of science and scientific knowledge


• Data, resources, and ideas should be shared among researchers


• Researchers should be urged to review and criticise each other’s work


Confidentiality


• Researchers must protect parts of the research project that should remain private (e.g., research plan, papers, personal records, and proprietary information)


• Researchers must protect study participants’ personal information


Respect for collegians


• Researchers must treat their peers, research staff, and students fairly and avoid causing them harm


• A researcher cannot discriminate against colleagues and students based on their sex, race, ethnicity, religion, or other characteristics, such as qualifications


• Researchers should help, educate, train, mentor, and advise their co-workers and students


Respect for intellectual property


• Every researcher must respect intellectual property, for example, copyrights


• Researchers must respect the work of others, i.e., they cannot use unpublished data or results without permission and must make sure to give credit to whom it belongs


• Researchers must avoid plagiarism


Freedom


• No organisation or institution should hinder a researcher’s right to independently conduct research


• Nobody should interfere with a researcher’s freedom of thought and inquiry


Protection of human research subjects


• Researchers are responsible for protecting the rights, dignity, and welfare of human subjects


• Researchers must protect research participants’ autonomy and obtain valid informed consent


• Any researcher who is involved with study participants must protect study subject privacy and ensure the confidentiality of their personal data


• Researchers should strive to minimise research harms and risks and maximise benefits


• Researchers should pay special protection to subjects from vulnerable populations


• Researchers must fairly distribute the benefits and burdens of research


Stewardship


• Researchers should make good and fair use of human, financial, and technological resources


• Every researcher is responsible for taking care of the research site as well as the research materials and tools


Respect for the law


• Researchers must conduct research according to relevant law and institutional policies


Professional responsibility


• Researchers should proactively improve their professional competence and expertise throughout their careers


• Researchers should promote scientific competence through mentoring, education, and leadership


• Researchers are responsible for reporting misconduct as well as any illegal or unethical activities that threaten the integrity of research


Social responsibility


• Researchers are responsible not only for the people participating in the research, but also for anyone who may be affected by their research results


• Researchers should avoid causing harm and strive to conduct research that will benefit society


• Researchers should share research results in an ethical way, inform the public about the research results, and provide policymakers information that supports decision-making




Shaw and Satalkar [36] found that researchers emphasise honesty and objectivity as the most important aspects of research integrity. Furthermore, they identified transparency as another key aspect of research integrity. The requirement of transparency is linked to many important objectives of ethical research, e.g., replicability, accountability, efficiency, the accumulation of evidence over time, and prevention of misconduct. The main tenet of transparency is that researchers must disclose all of the relevant aspects/steps of research, for example, the data collection process, rules used to analyse the data and research results, in an open and detailed way. Researchers can further increase the transparency of their research by making data publicly available whenever possible [36].


These principles also highlight that collaboration and trust are necessary for conducting ethical research [1]. Scientific research has become an increasingly collaborative process that involves multiple stakeholders, all of whom are responsible for the ethical conduct of research [2, 7, 37, 38]. For this reason, ethical standards have been created to guide anyone who is involved in the research process and promote values that are essential to collaborative research action, such as trust, fairness, and accountability [39], as well as mutual respect and equality, shared goals, and defined roles and responsibilities [37].


Trust is vital to promoting cooperation between stakeholders in areas such as collaborative work, publication, sharing data, and teaching and mentoring. Trust also facilitates interactions between researchers, funding sources, scientific journals, universities, research ethics committees, and the organisations that support and participate in the research process. Furthermore, trust is an important part of study subject protection [40]. For example, the development of researcher–study subject trust can positively affect study participant commitment to the research process [37]. Finally, public trust can be pivotal to gaining public acceptance for the planned research [40]. Public trust also enhances the social value of research and can positively influence the dissemination and utilisation of research results. Researchers can build public trust by actively improving community awareness of the ethical aspects of their research [37].


Every institution in which research is conducted has an obligation to follow ethical principles and promote ethical conduct of research through leadership, education, training, support, and supervision [23, 37, 39]. Certain organisational factors, for example, organisational culture and research environment, have been suggested to promote the ethical and responsible conduct of research [23, 37]. An organisational culture that actively highlights the principles guiding ethical research conduct can help researchers recognise their role in protecting human subjects and, as such, ensure their commitment to ethical compliance. Research infrastructure, i.e., research administration along with clearly explained processes and practices, is key to supporting researchers’ work in the complex research environment and maintaining organisation-wide research ethics [23].


6.4 Realisation of Ethical Principles in Content Analysis


Research is a process of thinking, planning, and the continuous processing of knowledge. In qualitative studies, the gathered data are analysed to create concepts of social phenomena. As such, the approaches used for data handling and processing directly reflect the initial study design.


A clear description of the data analysis procedure is important, but it may be difficult to provide clear and straightforward rules for certain analytical techniques. Data analysis begins with the definition of the research issues and the collection of data. However, the data analysis process must also consider ethical aspects, for example, researchers must recognise that content analysis also includes distinct ethical aspects. The ethical framework developed by Emanuel et al. is a valuable tool for improving the quality of a research design due to its structured nature and ability to serve as a guide for reviewing the ethical and scientific aspects of a research protocol [7, 4143].


This specific framework was developed with the overarching goal of minimising the possibility of exploitation by ensuring that the research process respects study participants and simultaneously benefits society [7]. The framework comprises the following eight ethical requirements: collaborative partnership, social value, scientific validity, fair participant selection, favourable risk–benefit ratio, independent review, informed consent, and respect for the person. Additionally, it includes practical guidelines and specifications for how these requirements can be fulfilled in research practice [7, 41, 42].


Emanuel et al. combined traditional codes of ethics, ethics declarations, and relevant literature on research ethics when developing the model [7, 41, 42]. For example, the four ethical principles presented by Beauchamp and Childress—autonomy, non-maleficence, beneficence, and justice—are incorporated into the framework [6]. The presented requirements are addressed in a chronological order that follows the steps of a typical research process and provides a systematic, organised, and coherent framework that researchers and ethics reviewers can use to determine whether their research is ethical [7, 4143]. It is important to note that these requirements are regarded as universal and applicable to all countries, settings, and context [43]. Even though ethical research must meet all of these requirements, certain requirements may have to be adapted to the circumstances of a specific research project (i.e., the health, economic, cultural, and/or technological conditions in which the research is conducted) [42].The ethical requirements presented in the framework are general statements of values; as such, they are applicable to all of the stakeholders that participate in the research process regardless of their professional background [7]. Therefore, it can be used to guide multi-professional discussion and decision-making concerning research ethics, and is also applicable to a wide range of qualitative research approaches.


The ethical framework, including the eight specific ethical requirements and their contents, is presented in Table 6.2. This table also provides brief descriptions of how each ethical requirement is relevant to qualitative research.


Table 6.2

The ethical framework presented by Emanuel et al. [41, 42], as well as examples of how it can be applied to a qualitative study





























































Requirement


Selected content


Examples from a qualitative study in the field of clinical research [27, 37, 38]


Collaborative partnership

 

• The community in which the research is conducted should participate in the research process (planning, conducting, and overseeing research as well as sharing the results)


• Collaboration among research stakeholders helps to ensure that the benefits of the research are fairly distributed and that community values, circumstances, culture, and social practices are respected


• The partners involved and their responsibilities in the research process should be clearly defined before the research is started


• This study was part of a collaborative research ethics project


• The planning of the study included collaboration between representatives of the target hospital’s administrative staff and scientific service centre. These stakeholders were especially involved in selecting the target population and designing the interview themes and structure


• The research process respected circumstances that were relevant to the organisational and study site circumstances, i.e., cultural and social practices. For example, the study participant recruitment process was planned carefully in collaboration with one representative of the organisation who knew the organisation and research sites well. The organisation’s concerns about the timing of the study participant recruitment were taken into account in order to avoid staff excessive workload or stress


Social value

 

• Research has social value if it generates scientific knowledge that can improve health or well-being (instrumental value)


• Research that does not produce social value exposes study subjects to risk and leads to the misuse of limited resources


• The potential social value, as well as potential beneficiaries, of research must always be defined


• Social value can only be realised if the results are effectively disseminated and implemented


• Researchers must investigate ways to increase the social value—and reduce the adverse impact—of research


• This study provides new knowledge about nurse leaders’ and administrative staff’s roles in ensuring and maintaining the ethical conduct of clinical research in their hospitals and describes their views of how ethical issues are covered in current clinical research practice.


• The results of this study can be utilised to improve the status and rights of clinical research subjects. In addition, this study increases the transparency of the clinical research process in university hospitals.


• The presented knowledge can be used for:


  – research management


  – planning and conducting ethical research


  – development activities


  – research ethics education


  – increasing public awareness about research ethics


  – enhancing multidisciplinary debates


  – increasing the visibility of research ethics


Scientific validity

 

• The study must be planned and conducted in a way that uses accepted scientific principles and methods to produce reliable and valid data (appropriate design and methods)


• The study must be designed in a manner that is practically feasible for the social, political, and cultural environment in which it is to be conducted


• The applied qualitative methods were chosen to provide a rich and comprehensive description of a phenomenon that had attracted limited research attention. The choice of a qualitative approach was appropriate because ethical aspects of clinical research are often complex, multidimensional, and conceptually oriented


• A secondary supra-analysis was employed to produce a broader and deeper conceptual understanding of the phenomenon under study. Data were analysed by deductive-inductive content analysis


Fair participant selection

 

• Selecting the target population based on the research objectives will ensure valid research


• Participants must be selected in a way that minimises risks and maximises the social value of research


• Selection criteria should be transparent and consistently applied


• If certain study participants are identified as vulnerable, specific safeguards are needed to protect these individuals


• The participants in this study were nurse leaders and administrative staff, including principal investigators, administrative managers, and elected officials. These study participants were selected as potential participants due to their professional responsibilities in enabling and managing clinical research in their hospitals


• The purposive sampling used to invite these participants had the following inclusion criteria: I) experience and knowledge in conducting clinical research; and II) willingness to participate in the study. The inclusion criteria were kept broad to minimise bias


A favourable risk–benefit ratio

 

• Researchers must identify and minimise the potential risks to study participants (including physical, psychological, social, and economic risks)


• Researchers must identify and maximise the potential benefits to study participants


• Researchers should also compare the potential risks and benefits of the planned study to create a risk–benefit ratio.


• The benefits to subjects should always reasonably exceed any risks to study subjects?


• It is possible that this study did not directly benefit the study participants. However, it is possible that they enjoyed sharing their views, experiences, and recommendations, and felt that their participation was beneficial, for example, to their organisation and to society


• The potential harms of the study were related to time and financial resources. The limited resources could have prevented the participant from participating due to work commitments. No financial compensation for participation was offered


• This study did not cause any psychosocial harm to study participants because the study topic was not sensitive. However, it is possible that some of the participants were concerned that their employers would know that they participated in this study or identify their opinions based on the study results. Thus, the participants were offered the opportunity to choose the interview time and location. In addition, the processes related to data privacy and confidentiality were explained to them


Independent review

 

• Researchers must minimise the possibility of conflicts of interest and ensure public accountability


• Researchers are responsible for ensuring that the study is conducted in compliance with the law and research ethics regulations


• Every study must include an independent, transparent, and competent review process


• This study did not involve sensitive research topics or participants who could be considered as belonging to a vulnerable group. Thus, according to Finnish research legislation, this type of research does not need approval from an official research ethics committee (Medical Research Act 488/1999)


• Organisational approval from both university hospitals was obtained according to hospital protocols


• The study was conducted in accordance with international and national ethical guidelines (Finnish Advisory Board on Research Integrity [8]; WMA [13]), and every phase of the study was in line with the national legislation (Medical Research Act 488/1999, Personal Data Act 523/1999)


Informed consent

 

• The recruitment process must take into account the local context (cultural, political, and social factors)


• Researchers must provide potential participants with accurate, but not overwhelming, information about the research (aim, methods, risks and benefits, confidentiality, etc.) in culturally and linguistically appropriate formats


• Researchers should consider using a combination of verbal and written information


• Participants must make a voluntary and uncoerced decision about participation


• If subjects who are unable to give their informed consent (e.g., because of their age or clinical status) are to be enrolled, legally authorised representatives of these individuals may make the decision to participate in their behalf as long as it is in line with the individual’s values and interests


• Researchers should ensure that study participants understand that they have the right to refuse or withdraw from participation.


• Representatives of the organisations were informed about the research and recruitment before the recruitment process started


• During the recruitment and informed consent process, participants first received written information about the aim of the study, voluntary nature of participation, handling, storage and confidentiality of the data, and their right to withdraw participation at any time. Potential participants were also informed about the possibility to contact the researcher by phone or email with additional questions related to the research. An information letter was sent to potential participants by email. The participants had time to consider their participation and then expressed their willingness to participate by sending an email to the researcher or representative of the organisation


• Before each interview, the researcher and interviewee discussed the information letter and its contents. Written informed consent was obtained from each participant before the interview began


• Written information and joint discussions were used to ensure that each study participant understood the voluntary nature of participation. The joint discussions served as an opportunity for the researchers to evaluate each participant’s understanding of their rights


• Consent for the secondary use of interview data in another research project was obtained from research participants during the informed consent process.


Respect for participants

 

• Researchers must monitor the health and well-being of study participants


• Researchers must guarantee every study participant’s right to privacy and protect their personal data


• Researchers must respect the study participant’s right to withdraw from participation at any time without penalty and ensure voluntary participation through the study


• Researchers must be aware of their post-research obligations, such as informing research participants and the community about the research results


• The interviews were conducted in a quiet and private place to ensure privacy and confidentiality of personal information


• The interviews were conducted by the same researchers, who also transcribed interviews verbatim. This further protected study subject privacy and personal data confidentiality


• The collected data were coded. Each participant was assigned a numerical code and any personal data that might identify participants were removed. Furthermore, the analyses were conducted without the possibility to identify any single individual


• Data were stored according to the legal requirements. As such, all the gathered data, tapes, and transcripts with no identification will be stored in a locked place with no access by anyone other than the researcher for 10 years. The results of the study were reported without any possibility of identifying individual participants


• The results of the study were reported as a scientific publication in peer-reviewed journal, as a publication in a professional journal and presented at national and international conferences. Copies of the dissertation and written scientific articles were given to the research organisations. Furthermore, the results of the study were presented at professional meetings

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Apr 18, 2020 | Posted by in NURSING | Comments Off on Research: Ethical Considerations
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