Index Page

Introduction-3
Why research needs to be regulated-4
Process of getting ethical approval-5
Anonymity, confidentiality, and privacy-6
Scientific misconduct-7
Vulnerable populations-8
Cultural aspects-9
Quantitative research-10
Qualitative research-11
Conclusion-12
Bibliography-13

Ethics are norms of conduct that distinguish between acceptable and unacceptable behaviour. Ethics are the principles and guidelines that help us to uphold things we value (Liaw and Tam, 2015). Research ethics refers to the field of ethics that systematically analyses the ethical and legal questions raised by research involving human subjects. The main focus is to ensure that the study participants are protected and that clinical research is conducted to serve the needs of such participants and society as a whole. The ethical principles of research include integrity, competence, non-maleficence, justice, dignity, beneficence, autonomy, honesty, responsibility, privacy and confidentiality. Research ethics involves the application of fundamental ethical principles to a variety of topics including scientific research. Research ethics educates and monitors a scientist conducting research to ensure high ethical standards. Successful research ethics only works when it is applied before the research has been conducted (Hendee, 2009). The focus of this e-book is to highlight important points to keep in mind to conduct a research study, which includes why research needs to be regulated, the process of getting ethical approval, scientific misconduct, vulnerable populations, considerations of cultural aspects and ethics of quantitative research and qualitative research. 

Introduction:

Ethics are norms of conduct that distinguish between acceptable and unacceptable behaviour. Ethics are the principles and guidelines that help us to uphold things we value (Liaw and Tam, 2015). Research ethics refers to the field of ethics that systematically analyses the ethical and legal questions raised by research involving human subjects. The main focus is to ensure that the study participants are protected and that clinical research is conducted to serve the needs of such participants and society as a whole. The ethical principles of research include integrity, competence, non-maleficence, justice, dignity, beneficence, autonomy, honesty, responsibility, privacy and confidentiality. Research ethics involves the application of fundamental ethical principles to a variety of topics including scientific research. Research ethics educates and monitors a scientist conducting research to ensure high ethical standards. Successful research ethics only works when it is applied before the research has been conducted (Hendee, 2009). The focus of this e-book is to highlight important points to keep in mind to conduct a research study, which includes why research needs to be regulated, the process of getting ethical approval, scientific misconduct, vulnerable populations, considerations of cultural aspects and ethics of quantitative research and qualitative research. 

Why does research need to be regulated ?

Research needs to be regulated to ensure the protection of subjects of research, and to assure accountability for ethical oversight on the part of institutions in which investigators work. It is important for research to be regulated to ensure appropriate steps are taken to protect the rights and welfare of human test subjects in the research being conducted. It is important to get for research to be regulated for researchers to protect themselves and others they research when they undertake any research involving other people and data that can identify other people (Liaw and Tam, 2015).


Researchers need to ensure that research participants' data and details are kept confidential unless they exist in the public domain and that they cannot be disadvantaged by participating in the research study. Researchers need to protect themselves and think carefully when collecting data as well as the risks that come with collecting the data (Liaw and Tam, 2015).

There are numerous steps to take in order to be able to receive ethical approval for a research study. The first step entails putting the research application into place, which includes all the necessary forms and documents required in order to begin with the research study. The next step of the process includes acquiring the signature from the director of the board. The individual below the board director, whom is known as the chief investigator will send all the documents and forms through to the director of the board. Once the signature is acquired from the director of the board, it will be sent to the Human Ethics Office. The third step of the process includes the Human Ethics Office examining the documents and forms to identify whether the research study has any risks that may not adhere to the principles of ethics, whether the research study is seen as suitable depends on the risk level, such as human test subjects being put into harm’s way or that could lead to a disadvantage for them. The fourth step entails the involvement of the Ethics Review Body whereby they review the application and decide whether the application will be approved or not. If the Ethics Review Body feels as if there are certain factors that do not adhere to the principles of ethics, the application can be turned down. Lastly if the application is seen as fit by adhering to the principles of ethics, the researchers will be notified by the Chief Investigator and the research study may be conducted (Liaw and Tam, 2015).

Process of getting ethical approval

There are numerous steps to take in order to be able to receive ethical approval for a research study. The first step entails putting the research application into place, which includes all the necessary forms and documents required in order to begin with the research study. The next step of the process includes acquiring the signature from the director of the board. The individual below the board director, whom is known as the chief investigator will send all the documents and forms through to the director of the board. Once the signature is acquired from the director of the board, it will be sent to the Human Ethics Office. The third step of the process includes the Human Ethics Office examining the documents and forms to identify whether the research study has any risks that may not adhere to the principles of ethics, whether the research study is seen as suitable depends on the risk level, such as human test subjects being put into harm’s way or that could lead to a disadvantage for them. The fourth step entails the involvement of the Ethics Review Body whereby they review the application and decide whether the application will be approved or not. If the Ethics Review Body feels as if there are certain factors that do not adhere to the principles of ethics, the application can be turned down. Lastly if the application is seen as fit by adhering to the principles of ethics, the researchers will be notified by the Chief Investigator and the research study may be conducted (Liaw and Tam, 2015).

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Anonymity, confidentiality and privacy

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Anonymity refers to a situation in which a person is not known by or spoken of by name, this means that no-one including the researcher knows the personal data of the participants.

Confidentiality refers to the state of keeping or being kept secret or private, this means that the researcher knows the personal data of the participants, however their identities are not revealed to those outside the study.

Privacy refers to the right of people to choose freely under what circumstances and to what extent they will reveal themselves, their attitude and their behaviour to others (Ryerson University, 2017).

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Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behaviour in the publication of professional scientific research. “Research misconduct means fabrication, falsification, plagiarism and violation of authorship rules in proposing, performing, or reviewing research, or in reporting research results” (Nylenna and Simonsen, 2006).

Fabrication refers to the creation of non-existent data and results and the act of recording or reporting them. Falsification refers to the manipulation of research materials, equipment, processes or omitting data and results so that the research is not accurately represented in the research record. Plagiarism refers to the appropriation of another person’s ideas, processes, results or words without giving the appropriate credit. Authorship refers to the listing of authors who actively contributed to the overall design and execution of the research study. Scientific misconduct may occur at any stage of the research process which includes data, generation, recording, review and the publication (Nylenna and Simonsen, 2006)

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Scientific Misconduct

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Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behaviour in the publication of professional scientific research. “Research misconduct means fabrication, falsification, plagiarism and violation of authorship rules in proposing, performing, or reviewing research, or in reporting research results” (Nylenna and Simonsen, 2006).

Fabrication refers to the creation of non-existent data and results and the act of recording or reporting them. Falsification refers to the manipulation of research materials, equipment, processes or omitting data and results so that the research is not accurately represented in the research record. Plagiarism refers to the appropriation of another person’s ideas, processes, results or words without giving the appropriate credit. Authorship refers to the listing of authors who actively contributed to the overall design and execution of the research study. Scientific misconduct may occur at any stage of the research process which includes data, generation, recording, review and the publication (Nylenna and Simonsen, 2006)

Vulnerable Populations

A vulnerable population group is a subgroup of the population who is more likely to develop health problems as a result of exposure to risk or to have worse outcomes from these health problems than the population as a whole (Miracle, 2010). Vulnerable population groups include racial and ethnic minority groups, uninsured, underinsured, low-income children, frail older adults, mentally disabled, homeless, physically disabled and people with HIV/AIDS (Shivayogi, 2013)

Without cultural competence, researchers risk imposing their beliefs, values and pattern of behaviour upon cultures other than their own. Cultural aspects that should be considered include language barriers, distrust of health care services, religious differences, beliefs in alternative medicines and unfamiliarity with the concept of palliative care. Researchers should ensure that no cultural aspect is taken for granted when conducting the research which avoids any participant from feeling threatened or uncomfortable whilst the ongoing research study (Halkoaho et al., 2016).

Cultural Aspects

Without cultural competence, researchers risk imposing their beliefs, values and pattern of behaviour upon cultures other than their own. Cultural aspects that should be considered include language barriers, distrust of health care services, religious differences, beliefs in alternative medicines and unfamiliarity with the concept of palliative care. Researchers should ensure that no cultural aspect is taken for granted when conducting the research which avoids any participant from feeling threatened or uncomfortable whilst the ongoing research study (Halkoaho et al., 2016).

Quantitative Research

Quantitative research involves several methods of data collection, such as survey-questionnaires, telephonic or online. The type of research requires that the variables under consideration should be measured (Ahmad et al., 2019).

Quantitative research uses larger samples of subjects or respondents allowing the researcher to generalize the data to the population from which the samples were drawn. This form of research is concerned with how often a variable is present and generally uses numbers to communicate this amount. The use of numbers allows greater precision in reporting results. These ethical norms include issues such as requirements for honesty, requirements for informed consent, anonymisation and storage of data, the right of access to data for participants and the duty of confidentiality for all those who undertake research (Chambers, 1997).

Examples of research studies for quantitative research include survey research, correlational research and experimental research (Ahmad et al., 2019).

Qualitative research involves an in-depth study of one or a few instances of a phenomenon so as to generate descriptions of characteristics of those phenomena for later analysis. Qualitative research is about the quality of data rather than the quantity of data. The description and what patterns are shared with an audience are what provide credibility. Qualitative data is best for capturing why a phenomenon occurs. While conducting qualitative research, researchers must adhere to the following ethical conduct, upholding informed consent, confidentiality and privacy, adhering to beneficence’s principle and practice of honesty and integrity. Beneficence’s principle refers to the duty to maximize benefits to enhance the human subjects’ well-being. Ethics in qualitative research include that the researchers must state values and biases in writing reports, researchers must take steps to ensure that accurate accounts of participant perceptions are written, researchers have the responsibility to use the data to enhance social change and consent is sometimes obtained through personal interaction with individuals or communities (Ahmad et al., 2019).

Examples of research approaches that are usually qualitative in nature include case studies, ethnography, interviews, participant observations and autoethnography (Ahmad et al., 2019).

Qualitative Research

Qualitative research involves an in-depth study of one or a few instances of a phenomenon so as to generate descriptions of characteristics of those phenomena for later analysis. Qualitative research is about the quality of data rather than the quantity of data. The description and what patterns are shared with an audience are what provide credibility. Qualitative data is best for capturing why a phenomenon occurs. While conducting qualitative research, researchers must adhere to the following ethical conduct, upholding informed consent, confidentiality and privacy, adhering to beneficence’s principle and practice of honesty and integrity. Beneficence’s principle refers to the duty to maximize benefits to enhance the human subjects’ well-being. Ethics in qualitative research include that the researchers must state values and biases in writing reports, researchers must take steps to ensure that accurate accounts of participant perceptions are written, researchers have the responsibility to use the data to enhance social change and consent is sometimes obtained through personal interaction with individuals or communities (Ahmad et al., 2019).

Examples of research approaches that are usually qualitative in nature include case studies, ethnography, interviews, participant observations and autoethnography (Ahmad et al., 2019).

Conclusion

In conclusion, when a researcher is wanting to conduct a research study, they should ensure they are fully aware of the ethical principles that should be adhered to and what steps need to be followed to ensure receiving ethical approval to continue with their research study. If the researcher takes vulnerable populations and cultural aspects into consideration, it will help them achieve ethical approval. If the researcher makes certain to avoid any form of scientific misconduct, it will help in achieving ethical approval. Therefore, once the researcher has suitable ethical principles adhered to and acknowledges the importance of the research process, ethical approval, vulnerable populations and cultural aspects it could lead to a successful research study.

Ahmad, S. et al. (2019) ‘Qualitative v/s. Quantitative Research- A Summarized Review’, Journal of Evidence Based Medicine and Healthcare, 6(43), pp. 2828–2832. doi: 10.18410/jebmh/2019/587.
Chambers, L. W. (1997) ‘Qualitative and quantitative research methods’, Canadian Journal of Public Health, 88(1), pp. 9–10. doi: 10.1007/BF03543069.
Halkoaho, A. et al. (2016) ‘Cultural aspects related to informed consent in health research: A systematic review’, Nursing Ethics, 23(6), pp. 698–712. doi: 10.1177/0969733015579312.
Hendee, W. R. (2009) ‘Ethics in research’, IFMBE Proceedings, 25(13), pp. 204–205. doi: 10.1007/978-3-642-03895-2_59.
Liaw, S. T. and Tam, C. W. M. (2015) ‘Research ethics and approval process: A guide for new GP researchers’, Australian Family Physician, 44(6), pp. 419–422.
Miracle, V. A. (2010) ‘Vulnerable populations in research’, Dimensions of Critical Care Nursing, 29(5), pp. 242–245. doi: 10.1097/DCC.0b013e3181e6d13e.
Nylenna, M. and Simonsen, S. (2006) ‘Scientific misconduct: a new approach to prevention’, Lancet, 367(9526), pp. 1882–1884. doi: 10.1016/S0140-6736(06)68821-1.
Ryerson University (2017) ‘Guidelines on Anonymity and’, pp. 1–7. Available at: https://www.ryerson.ca/content/dam/research/documents/ethics/guidelines-on-anonymity-and-confidentiality-in-research.pdf.
Shivayogi, P. (2013) ‘Vulnerable population and methods for their safeguard’, Perspectives in Clinical Research, 4(1), p. 53. doi: 10.4103/2229-3485.106389.