What can you do to ensure that you treat your participants with respect?
- Be respectful when speaking about participants. ...
- Avoid showing them how they're wrong. ...
- Don't create unnecessary tension in groups. ...
- Don't try to sell them things. ...
- Don't try to teach them things. ...
- Protect their privacy in the community. ...
- Protect their privacy in final reporting. ...
- And finally, end your groups on time.
How would you ensure that the participants in your experiments are treated ethically and have their rights protected?
What should an ethical researcher do to protect participants?
What ethical obligations does a researcher have to ensure their participants are fairly treated in a study?
How can I apply ethical principles and guidelines when I do research?
- All participants in research must take part voluntarily, free from any coercion or undue influence, and their rights, dignity and autonomy should be respected and appropriately protected. ...
- Research should be worthwhile and provide value that outweighs any risk or harm.
What is ethics and how does it apply to research with human participants?
How do you protect participants anonymously?
Which of the following practices ensure the confidentiality of research participants?
Methods for keeping data confidential range from using routine precautions, such as substituting codes for participant identifiers and storing data in locked cabinets, to more elaborate procedures involving statistical methods (e.g., error inoculation) or data encryption.
Why is it important to protect human participants?
How can a good researcher balance ethical consideration and bias?
Why do we have to be concerned with ethics when conducting a research study?
What makes a study ethical?
What is respect for individuals involved in research?
Respect for individuals involved in research means appreciating their autonomy —their independence and freedom to make a decision without external influences. They should be allowed to make an informed decision whether or not to participate in research based on both written and verbal information that has been provided to them through an informed consent process. In other words, individuals can only take part in research “voluntarily” ( 8 ). “Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.” (Declaration of Helsinki 2013-Paragraph 25) ( 9 ).
What is responsible conduct of research?
Responsible conduct of research is not just knowing the three research ethics principles or published guidelines. It is about putting everything that has been discussed so far together in real life situations. I illustrate this point with two examples of public health research and discuss some of the ethical issues involved.
What are the two sections of informed consent?
The documents at the very least should contain two sections: a Participant Information section and a Signature section. The Participant Information section should include the following information ( 10 ):
What is the definition of privacy in scientific research?
In scientific investigations, researchers can only access information about a participant that the participant has agreed to divulge. Confidentiality is concerned with who has access to that information once it has been accessed by the researchers. The Declaration of Helsinki states: “Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.” (Declaration of Helsinki 2013-Paragraph 24).
What is the second principle of ethics?
The second research ethics principle is beneficence, and it is coupled with non-maleficence. This principle is concerned with maximizing benefits and minimizing harm to research participants. Some early scientists believed that there should be no boundaries in the quest to further knowledge. In 1895, a prominent Chemist at the University of Chicago wrote, “A human life is nothing compared to a new fact in science. The aim of science is the advancement of human knowledge, at any sacrifice of human life” ( 20 ). Such attitudes, which were widespread in the United States until the middle of the twentieth century, led to the abuse of human subjects in the name of scientific research. Ethical guidelines changed this paradigm, so that now the welfare of the research subjects is always a priority. “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.” (Article 8, Declaration of Helsinki, 2001) ( 3 ).
What is the aim of science?
The aim of science is the advancement of human knowledge, at any sacrifice of human life” ( 20 ). Such attitudes, which were widespread in the United States until the middle of the twentieth century, ...
What is the principle of justice in research?
The principle of justice in research is about fair distribution of burdens and potential benefits of participation in research. The health of all members of a community or population is equally important, and all those who are eligible should have an opportunity to take part in research without discrimination. “Groups that are underrepresented in medical research should be provided appropriate access to participation in research.” (Declaration of Helsinki, 2013-Paragraph 13) ( 9 ). This provision, however, does not necessarily mean equal involvement of everyone in research, because the needs of certain sub-populations may differ from one another. Equity should be a key consideration, with sub-populations with the greatest health needs receiving priority ( 24 ).
What is the common rule for research?
The federal regulations governing research with human subjects, which have been adopted by numerous federal departments and agencies, are often referred to as the Common Rule, which is modified from time to time. They were first written by the Department of Health and Human Services (DHHS).
What are the three basic ethical principles?
– obtain and document informed consent.
Can you collect data from minors without parental consent?
For example, we usually cannot collect data from minors without parental or guardian permission. All research participants must give their permission to be part of a study and they must be given pertinent information to make an “informed” consent to participate. This means you have provided your research participants with everything they need ...
What is the protection of privacy and confidentiality?
Protection of privacy and confidentiality. Protection against unjustifiable deception. The subject must give voluntary informed consent to participate in research. Guardians must give consent for minors to participate. In addition to guardian consent, minors over age 7 (the age may vary) must also give their consent to participate.
What is the importance of Henry Beecher's article?
In it he described 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. He noted that “unethical or questionable ethical procedures are not uncommon.” Beecher’s article played an important role in heightening the awareness of researchers, the public, and the press to the problem of unethical human subjects research.
What was the National Research Act of 1974?
The publicizing of the Public Health Service Syphilis Study at Tuskeegee (1932-1971) led to the establishment of the National Research Act of 1974 which created a national commission that ultimately issued the Belmont Report (1979).
What is an IRB review?
The IRB review system is designed to provide an independent, objective review of research involving human subjects so that the privilege of conducting human subjects research may be maintained. Only activities that meet the definition of research with human subjects need review by an Institutional Review Board (IRB).
What are human subjects ethics?
National and international organizations have issued declarations on human subjects research ethics in response to medical experiments throughout history that were done on participants who did not consent to being treated, Dronitsky says . These include experiments on prisoners of war in German concentration camps in World War II, the Tuskegee Syphilis Study in the United States from 1932 to 1972, and various vaccine or pain study trials that took advantage of persons with mental disabilities or other underrepresented groups. The three major declarations each consist of several principles of research that act as scientific and moral guidelines for treating people who have agreed to be part of a research study.
What are the principles of human subjects?
Principles of Human Subjects Research Ethics. National and international organizations have issued declarations on human subjects research ethics in response to medical experiments throughout history that were done on participants who did not consent to being treated, Dronitsky says.
What industries are highly regulated?
In highly regulated industries such as medical devices, pharmaceuticals, biotechnology, and food safety , companies must constantly balance the demands of bringing new products to market quickly while also testing those products in a safe manner. Many of these products are tested on human subjects, and successful studies can improve human health ...
What are the three major declarations?
The three major declarations each consist of several principles of research that act as scientific and moral guidelines for treating people who have agreed to be part of a research study.
What does the Declaration of Helsinki call for?
The Declaration of Helsinki also calls for all research experiments to include a research protocol that indicates how principles of human subjects research ethics are being addressed, along with information about who is funding or otherwise sponsoring the research.
When was the Belmont report written?
Belmont Report. Written in 1978 in response to the Tuskegee study—in which 400 Black men with syphilis were neither informed of their diagnosis nor treated for the disease for decades—the Belmont Report provides guidance for the treatment of human subjects in research trials in the United States. The report builds on both the Nuremberg Code and ...
What are the emerging trends in biotechnology?
One of the emerging trends in biotechnology is the personalized treatment of rare diseases, made possible through highly targeted treatment plans and therapies that are, in some cases, based on a patient’s genetic and molecular makeup.
Why do researchers use qualitative methods?
Therefore, researchers can interpret people’s experiences because they are involved in human activities.
What is the role of a researcher in a qualitative study?
In qualitative studies researchers are often required to clarify their role in the research process (11) . In the QR procedure the researcher is involved in all stages of the study from defining a concept to design, interview, transcription, analysis, verification and reporting the concepts and themes.
Why is qualitative research used?
Research design. The qualitative method is utilized to explain, clarify and elaborate the meanings of different aspects of the human life experience. Therefore, researchers can interpret people’s experiences because they are involved in human activities.
What is confidentiality in healthcare?
For health care practitioners, confidentiality means that no personal information is to be revealed except in certain situations.
Reference
1 Code of Federal Regulations, Title 45, Public Welfare. Department of Health and Human Services, Part 46, protection of human subjects, subpart A, section 46.111, criteria for IRB approval of research. Available at: ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm ). Accessed December 5, 2008.
Ethical Approval for Studies Involving Human Participants
From Academic Medicine ’s Editorial Policy, Publication Ethics, and Complete Instructions for Authors, available in full at ( http://journals.lww.com/academicmedicine/Pages/InstructionsforAuthors.aspx).
Why Do Research Ethics Matter?
Getting Ethical Approval For Your Study
- Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB). An IRB is a committee that checks whether your research aims and research designare ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures ...
Types of Ethical Issues
- There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other. You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect datafrom participants.
Voluntary Participation
- Voluntary participationmeans that all research subjects are free to choose to participate without any pressure or coercion. All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study. It’s important to make it clear to participants that there are no negative con…
Informed Consent
- Informed consentrefers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval. Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree t…
Anonymity
- Anonymitymeans that you don’t know who the participants are and you can’t link any individual participant to their data. You can only guarantee anonymity by notcollecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos. In many cases, it may be impossible to truly anony…
Confidentiality
- Confidentialitymeans that you know who the participants are, but you remove all identifying information from your report. All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can. Some research designs aren’t conducive to …
Potential For Harm
- As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms. 1. Psychological harm:Sensitive questions or tasks may trigger negative emotions such as shame or anxiety. 2. Social harm:Participation can involve social risks, public embarrassment, or stigma. 3. Physical harm:Pain or injury can result from the study proce…
Results Communication
- The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible. Take steps to actively avoid plagiarism and research misconduct wherever possible.
Examples of Ethical Failures
- Research scandals with ethical failures are littered throughout history, but some took place not that long ago. Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity. To demonstrate …