Part 2 – Overview of Terms and the Belmont Report

An overview of terms

A study is led by a Principle Investigator (or PI), who is the leader and point of contact in a study for participants, staff and the institution. To aid them in this process, a research assistant will assist in things like enrolling subjects, assisting in experiments or interviews, collecting data, helping with calculations or similar roles. You should be in contact with your PI and go to them in the event that you have questions or concerns related to your duties during the study.

Research on human subjects usually requires ethical oversight by an Institutional Review Board (IRB), a group of individuals that reviews studies to assure they are ethical and abide by a body of federal laws that govern human research practices called Common Rule. Once a study is approved by an IRB, its parameters cannot be changed without the PI first consulting and notifying the IRB.

Before a participant can partake in a study, they must first review and sign an Informed Consent, which is a document that explains all the key information about the study and the risks involved. More details will be given on the consent process later. Further, any information that an individual does not want publicly known is deemed private personal information and is considered especially important to keep confidential.

A research aide or assistant’s job is to help the Principle Investigator with performing the actual study itself. It is very important to follow the instructions of a PI even if they seem tedious or cumbersome, as the PI will be beholden to a very complex set of ethical regulations. Furthermore, if there is ever an unexpected accident or incident in the study, it is important to immediately contact the PI and inform them.

 

Ethics basics

A document that outlines the basis of human research ethics, the Belmont Report, was released by the federal government to help establish the guiding principles that research with human subjects should follow. There are three core values that the Belmont Report outlines that anyone involved in human research should be familiar with:

Respect for Persons – A human research subject must at all times be voluntarily participating in the study and further, fully informed of the risks posed to them. At no point in the study must they feel pressured to choose one way or another – including to participate. Therefore, it is important to note that all research participation must be voluntary, which means they have the option to not involve themselves in the research and further be able to withdraw at any point. Additionally, they must never feel pressured or overtly influenced in making this decision, be it by coaxing from research staff or feeling unduly swayed by incentives like pay or status to disregard risks to themselves. Finally, unless the study requires the subject to be unaware of certain parameters to gain accurate data (which the PI will be able to decide), the subject must have a clear understanding of everything they will be expected to do in the study and any risks or benefits posed to them. At no point should a research aide or assistant attempt to sway a subject to participate nor conceal information about the study, even if they disagree with the subject’s choice. Subjects also may drop out of a study at any point, even after signing Informed Consent, and this decision should be immediately accepted and not contested.

Beneficence – Research should always consider the well-being of the subjects and maximize the benefits while minimizing any risks or negative effects. All due concern and attention should be given to minimizing risk for human research subjects, and the principle risk in most social science research is a breach of confidentiality. Therefore, the information gained from subjects must be treated respectfully and kept secure. As a research aide or assistant, accessing and reviewing this information outside of the study parameters is strictly prohibited. You are not to talk about personal information of subjects outside the study or talk to subjects about their participation afterwards, especially when sensitive information is involved.

Justice – Research on human subjects must be both representative of the sample population and not biased in its benefits or risks. This value primarily concerns itself with who is selected to participate with the study. If the study is paid, then subjects should not be selected based on the personal preferences of the research staff, or if the subject involves risks, it is important to not attempt to shift the sample population to people with lower incomes or disadvantaged backgrounds. If a large number of research subjects is needed, is important to not select only subjects that are convenient or nearby. As a research aide or assistant, it is important to assure that those selected for the study chosen in an unbiased way that will not skew study results. You are welcome to suggest participants to a study, but assure that it is because these individuals will further the research project, not because of personal relationships or to attempt to direct participation incentives.