Ethical Principles in Research- Protecting the Research Participant

Ethical Principles in Research- Protecting the Research Participant

One of the critical decision points for the coordinator involved proceeding with the clinical trial without obtaining informed consent from the participant. The participant wanted to participate in the trial without fully knowing what the trial was about and what she was supposed to expect. The coordinator had the choice of letting her sign the papers without a comprehensive understanding of the process, but she decided to take time and explain to her what the study entailed. The process of obtaining informed consent should involve explaining the purpose of the study, if applicable, payment for participation, time and procedures involved, potential discomfort and risks, confidentiality, rights of the research participants, potential benefits to the society and the subject, withdrawal, and participation as well as identification of the investigators (Stangor, 2010).

The Internal Review Board places emphasis on the need to obtain informed consent before beginning any research that involves humans. This consent should be obtained from the IRB as well as the potential participants. It was important for Jen to obtain informed consent from the client in order to maintain integrity. The client needed to understand what the study was about, the potential risks, and her choice to participate or withdraw, among other things, before signing up for participation. This would help her to make an informed choice about the clinical trial. Furthermore, obtaining consent would help prevent any potential lawsuits or litigation, improve the relationship, build trust between the researcher and the participant, and enhance the participant’s autonomy and respect as an individual. Maintaining professionalism would require one to stay up-to-date with the current requirements of the IRB, and in this case, ensuring that informed consent is obtained from the client will be one way of upholding professionalism at work.

According to Stangor (2010), one of the most significant tools for offering freedom of choice and lessening psychological stress from taking part in behavioral research is making use of informed consent. The role of informed consent is to make sure that the participants take part in the study voluntarily and with full knowledge and information about what they are getting themselves into.

Data integrity or validity is important for advancing scientific and medical knowledge. It also helps to maintain public trust in the research, and therefore, issues of falsification of data are highly condemned in research (Kleppner, 2019). While conducting research that involves human participants, it is also important for them to understand their rights. For instance, it is crucial for the participants to note that they have the choice to participate or withdraw from a research study, and their decision needs to be completely voluntary. Participants should also be informed of any other non-research treatment choices that they might have. It is important to note that participants who are economically disadvantaged are less likely to decline to take part in research where monetary rewards are offered. Therefore, the freedom of voluntary choice is not always easy (Stangor, 2010).

Lastly, taking care of the welfare of the participants by ensuring that consent is obtained and that minimal or no harm comes to them in the course of the research is important. This will help improve trust between the researcher and participant as well as other stakeholders like investors and will also help minimize the potential of legal suits against individuals and the institution as a whole.

References

Kleppner, D. (2019). Ensuring the integrity, accessibility, and stewardship of research data in the digital age. National Academies Press.

Stangor, C. (2010). Research Methods for the Behavioral Sciences. (4^th ed). Wadsworth Cengage Learning.

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The ethics information covered in your text was from the viewpoint of a Principal investigator (i.e., the researcher responsible for the study). However, not everyone serves as a Principal investigator (PI); there are other roles individuals can play in research. One specific example is a large research project where the PI hires individuals to help in the data collection, analysis, and reporting. There are various ethical scenarios that can arise during data collection, analysis, and reporting. The video above covers three different scenarios and what should be done when faced with one of these situations.

Now that you know the importance of protecting the rights and welfare of Human Research Participants and that it is mandatory for every member of a research team. To engage in this interactive exercise, go to The Research Clinic  (Links to an external site.)and click on “Play Full Video.” Watch the introductory video all the way to the end.

Once that video is over, you will be presented with four different characters from which you will select the clinical research coordinator, “Jan Klein, RN.” Feel free to play other parts, but for this short assignment, address the questions from the experience of this character.  Take a screenshot of the final page after completing the activity.

ASSIGNMENT INSTRUCTIONS

After completing The Research Clinic activity:

Submit a screenshot of the final page before returning to the main menu.

Choose one of the critical decision points for the coordinator.

In one to two paragraphs, explain why the decision was critical to maintaining integrity based on the Internal Review Board (IRB) protocol.

Explain the role of informed consent, data integrity/validity, participant rights, and participant welfare.