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Research Ethics in Action

Various approaches are used to put guidelines and laws into practice. For example:

Informed consent
Informed consent is a process by which a person is provided with enough information about a study to decide whether he or she would like to participate. In this process, trial-site staff educate the prospective participant about the study, including the potential risks or harms, the potential benefits, study procedures, and what is expected of participants. The informed consent process then involves a written document called the informed consent form — which includes all of this information and more. An individual interested in volunteering for a study provides consent, and this is then documented on the informed consent form. Informed consent should be an ongoing process in which participants may decide to drop out of the trial at any point, even after providing consent to enroll in the study.

Study Design
1. Risk-benefit ratio
Researchers are expected to design studies that minimize risks to potential participants and implement every reasonable safeguard to protect participants from harms. Ethics review committees and other regulatory bodies review protocols to determine whether a trial should take place. If its risks seem too great in comparison to the benefits a participant might receive, then the study might not be approved, or it might be considered again once it has been redesigned by the investigators.

2. Selection of participants and location
For later-stage trials, participants in studies should be from populations who would benefit from the research findings. Such trials should therefore be conducted in locations where the illness exists and with participants who face or may face the particular health problem.

3. Full disclosure about alternative ways to treat the illness (for treatment studies) or offering a full package of ways to prevent the illness (for prevention studies)
When people consider joining a trial, they must be informed about other ways to treat their health problem (or prevent it) so they can decide whether to seek treatment that is already established or to agree to participate in a trial to test an experimental strategy. In the case of biomedical HIV prevention trials, ethical guidelines stipulate that participants be provided with information about how to reduce their risk of getting HIV and be offered other known prevention strategies like condoms, testing for and treatment of STIs, and clean needles. As new treatments or methods of prevention become available, participants should be informed about them.

Ethics Committees
Ethics Committees (ECs) and Institutional Review Boards (IRBs) are committees that sit within different institutions that conduct research, such as hospitals, universities, and government agencies. The role of these committees is to review research protocols and determine if they are ethically and scientifically sound. These committees include people who have expertise in scientific areas and also usually at least one person who is not a scientist but who has experience and expertise in other areas. Ethics committees are also expected to be diverse, with not all members representing one sex, age group, or cultural background.

These committees review protocols and make decisions about whether a research study can be conducted by their institution. Specifically, they might approve the research, require changes to the research, or deny approval of the research. Most research protocols must receive approval from several ECs or IRBs in order to proceed. This is particularly true with large international studies, where research is conducted at multiple sites and countries. In studies such as these, the protocol will have to be approved by the Ethics Committees at the sponsor organization, at the network conducting the study, at the institution receiving funds to conduct the research, at the sites where the research will take place, and by the governments of the countries where the research will take place.

What guidelines and laws have to be followed?
All research is funded by a sponsor — such as a government, a research organization, or a pharmaceutical company — and the sponsor of the research determines which regulations or guidelines must be followed, as does the country where the research is being conducted. For example, with research that is sponsored by the US government but conducted in another country, researchers must follow the laws and guidelines specified by both countries. Non-government sponsors of research must also follow the laws of the countries where the research is conducted, but they may specify additional ethical research guidelines to be followed.

Do these guidelines prevent all controversies and ethical breaches?
No. Challenges can still arise despite the many laws, guidelines, policies, and practical applications that have been put into place to help ensure that research conducted on human participants is done ethically. What is considered "ethical" changes over time, and different stakeholders may have varying views about what is "ethical" and what is not. There have been many controversies around clinical research over the years, where stakeholders disagreed about whether a trial was being conducted ethically, even causing trials to be shut down. It is the responsibility of funders to provide enough money to allow researchers to conduct the research ethically, of researchers to follow ethical guidelines and norms, and of community members who want to engage in the process to learn about research so that they can make constructive criticism to the process.