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Key Principles of Ethical Research

Key Principles of Ethical Research

When you are conducting research there are a number of ethical principles that should be taken into account, especially if your research involves human subjects. One basic principle all researchers should follow is ‘do no harm’. To adhere to this principle, you should ethically recruit subjects for your study, obtain informed consent, minimize any risks, be transparent throughout the study, always protect the anonymity and confidentiality of subjects and data, and obtain approval for your study through an Institutional Review Board or an Ethics Board.

1. Recruit Participants

There are a number of ethical considerations to take into account when recruiting participants for your study. You should develop recruitment strategies for finding subjects. Whatever recruitment strategy you employ, you need to ensure that the privacy of potential subjects is respected. If someone volunteers to be part of your study, you need to let them know what data will be collected and who else might see these data. Make sure you do not pressure potential participants into volunteering. Give them all of the information about the study and allow them ample time to decide whether they are willing to do what the study requires of them. Make sure that you present the study in an unbiased and objective way, outlining all procedures, benefits and any risks. Let potential participants know exactly how much time will be involved and what will be expected of them.

2. Obtain Informed Consent

Obtaining informed consent is ethical and is required for Institutional Review Board approval. When seeking informed consent, you must provide all relevant information about the research study to the subjects, in writing. In the United States, federal regulations mandate that if a research study involves subjects under 18 years of age, consent must be obtained from the parent or legal guardian and from the child. Examples of informed consent forms are available online, so you can use these as a guide. For example, here is a link to an Informed Consent Form Template from Trinity College Dublin, Ireland. Remember, when developing forms for children you should use age-appropriate language. When providing informed consent, researchers should inform subjects about how certain aspects of the study will specifically affect them. Explain the purpose and aim of the study, and let subjects know what the study procedures are and how long the study is expected to last. Make sure that participants understand all potential risks and any potential research benefits. Let them know that it is within their rights to not participate or to withdraw from the study at any point. You should also explain to the subjects how data will be entered, maintained, coded, and shared. This should include an explanation of all measures taken to reduce risk of breach of confidentiality and the limitations of these measures.

3. Minimize Risks

You need to determine how likely it is that any risks will occur and what the impact will be if they do. Develop a detailed plan for how you will ensure that your subjects receive necessary medical or professional intervention if they suffer any negative effects because of your intervention. Decide how you will ensure the safety of your subjects during the research project. Try to consider not only the physical risks, but also any psychological, financial, legal, or other risks participating in the study might pose. Write down each risk and determine what steps you will take to minimize that risk. Make sure that your research study relies on valid scientific methods. This will help to minimize risks to participants. Include a detailed description of all study procedures when you submit for Institutional Review Board approval. The board will identify areas that do not seem to minimize risk or where a more detailed plan is needed. There are approaches you can take in your study design which can minimize risk. Collect only data that are absolutely essential for the study. There is always a risk when you gather, analyze, store and share data. More data bring greater risk. The same is true for study procedures. Minimize the number of procedures in the study, including only those that are necessary. Make sure that you have developed identifiers and a robust coding scheme to protect confidentiality.

4. Privacy and Confidentiality

Provide subjects with clear and accurate information about what data will be collected, how the data will be used, how the data will be stored – with specific information about photographs, audio tapes, video tapes and medical records. Also explain how long it will take for the data to be destroyed following completion of the study and how the data will be destroyed. Understand any institutional, or government policies that apply to the handling of research data. The Office of Research, or equivalent, at your institution should be able to provide advice regarding these policies. Make sure you have access to a secure area with limited access where your data can be stored. Many researchers have documents with confidential information stored in a locked cabinet in a locked office or data room. In addition, make sure that your data collection techniques also allow for privacy and confidentiality. For example, if you are conducting interviews with participants, make sure that the interviews are held at a location where you cannot be overheard. Make sure that subjects’ names do not appear on any documents, such as surveys, that other researchers might see, or that research assistants might use for data entry. Have a clear data sharing plan that maintains confidentiality and make sure that everyone in your research group understands the plan. Include any plans for data sharing in the information provided to participants when asking them to consent. Make sure you include all types of data that will be shared when telling potential subjects about the data sharing plan. These might include video tapes, photographs, medical records, interviews, surveys, or audio recordings. Unless you have obtained signed consent to share specific data, it is unethical to do so even if it enhances your study.

5. Transparency

Obviously, you must maintain the integrity of the research study and respect privacy and confidentiality. But beyond that, you should be transparent with participants and your research group throughout your study. Explain possible risks, limitations to confidentiality approaches, and be forthcoming about any possible breach of privacy or confidentiality, if these occur during the study. Disclose any potential benefits of the study to the researchers. Inform participants about how the study is funded and name the funding organization.

6. Ethics Board Approval

Research studies should be approved by an Institutional Review Board or Ethics Board before they commence. Most funding agencies require this. There are a number of questions that guide review boards in reviewing proposals. The following questions are generally included:

✓ Are the risks to human subjects reasonable in comparison to the benefits and are those risks minimized?

✓ Is the study well designed?

✓ Is the selection of subjects fair?

✓ Has the informed consent process been clearly articulated and is it appropriate?

✓ Does the research study comply with required special considerations for vulnerable populations, for example children?

✓ Will subjects’ privacy be protected?

✓ Is there a clear plan for keeping data confidential and destroying data when appropriate?

There are many resources you can use to help you conduct ethical research. Most institutions have an office of research where you can seek advice. In addition, most institutions offer webinar training on ethical research and these are often mandatory. Many organizations publish codes and policies for research ethics. These include the National Institutes of Health, the National Science Foundation, and the World Medical Association’s Declaration of Helsinki.

 

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