How Are We Protected Today?

Today, there are guidelines, regulations, and laws in place to ensure that research is conducted ethically, and with respect, fairness, and good treatment for all participants.

The Belmont Report established a set of guidelines to inform ethical research conduct. From these guidelines, Institutional Review Boards (IRBs) were established to oversee research practices at an institutional level, and the informed consent process is now the standard introduction for all prospective research participants.

All researchers must comply with numerous regulations before they can even begin their research study. All researchers and research staff must complete required training in research ethics before they can start their research studies.

Additionally, all professions (e.g., nurses, dentists, doctors, sociologists, etc.) have codes of ethics that guide conduct in research and/or in practice. People who conduct health and medical research are also guided by professional codes of ethics.

There are many systems in place to help to protect people who participate in research. Still, you, as an informed decision maker, are your own best protection when it comes to making smart decisions about participating in research. You should always feel confident about knowing what information you need to make an informed decision.

The Belmont Report

The Belmont Report is a report produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. This serves as the primary resource in the U.S. for conducting ethical research involving human subjects. The report summarizes the ethical principles that underlie all research involving human subjects and includes guidelines to ensure that these principles are followed. Three core principles identified in the report are:

  1. respect for persons
  2. beneficence ("to do good")
  3. justice.

The report focuses on three areas where these principles can be applied: informed consent, assessment of risks and benefits, and the selection of subjects.

The Belmont Principles

The three core principles identified in the Belmont Report, particularly relevant to the ethical conduct of research, are: respect for persons, beneficence, and justice. Respect for persons is the idea that all people who participate in research must do so voluntarily and with enough information to make an informed decision. Individuals who are unable to determine for themselves if they should take part in a research study or not (due to illness, mental disability, age, or other circumstances) are given special protection and consideration. Beneficence refers to protecting the well-being of an individual in a research study. Two general rules to follow to ensure beneficent actions are:

  1. do not harm
  2. maximize possible benefits
  3. minimize possible harms.

The principle of justice considers that both the burdens and benefits of research should be shared equally. That is, one group should not be selected to participate in research simply because they are easily available, in compromised positions (imprisoned or confined to institutions) or otherwise manipulated (low-income individuals offered large cash incentives to participate), particularly when these groups would be unlikely to benefit from the results.

Institutional Review Boards (IRBs)

An Institutional Review Board (IRB) is a committee responsible for reviewing research studies involving human subjects. The IRB's priority is to ensure that humans participating in research are protected from harm and are treated ethically. The IRB, also known as an ethics review board or independent ethics committee, must review, approve, and monitor all research involving humans, including clinical trials, behavioral studies, survey taking, focus groups, etc. The IRB examines all documents used for informed consent, reviews how the benefits and risks of the research are described, and requires that researchers share specific information with potential participants. IRB members can be researchers, non-researchers, or concerned community members.

Informed Consent

Before an individual can take part in a research study, he or she must first agree to participate. This is called "giving informed consent" and is based on the individual:

  1. having received information about the study,
  2. understanding the information given, and
  3. freely agreeing to join the study.

In other words, informed consent is the voluntary and knowledgeable agreement to participate in a research study. Informed consent is based on the principle of "respect for persons" identified in the Belmont Report, and requires that research subjects have the opportunity to choose what shall or shall not happen to them. Researchers must always include an informed consent process prior to allowing anyone join their study. During this process, potential subjects are given information about the study, what they will be asked to do and what will happen to them, potential risks and benefits, and are given the opportunity to ask questions.

Independent Review Before Funding a Study

All research studies go through multiple independent reviews by peer researchers. In each review, the treatment of human participants is examined to ensure that the research will be done in an ethical manner.

Data Safety Monitoring Boards

Many studies, particularly if they involve a treatment, drug or program to improve health, have an independent board called a Data Safety Monitoring Board. This board, consisting of people who are not working on the study, gets regular reports from the research team for the purpose of determining that participants are being treated fairly. Sometimes, a Data Safety Monitoring Board will recommend that a study stop because it involves a risk to participants that had not been previously foreseen. Similarly, sometimes the Board may recommend stopping a study early because the treatment being studied in the research is proving to be very effective and safe, and the board might recommend moving early toward seeking approval of the drug.

The Right to Leave a Study

Finally, one way that participants are protected in research is that they have the right to stop their participation at any time.

Important Question

How do these protections for human subjects shape your willingness to participate in research today?