Human Research Ethics

As defined in the beginning of this chapter, primary research is any research that you do yourself in which you collect raw data directly rather than from articles, books, or internet sources that have already collected and analyzed the data. If you are collecting data from human participants, you may be engaging in human subjects research. When conducting research with human participants, you must be aware of and follow strict ethical guidelines required by your academic institution. Doing this is part of your responsibility to maintain academic integrity and protect your research subjects.

In the United States, human subjects research is guided by three core principles outlined in the Belmont Report: respect for persons, beneficence, and justice.^[1] The first principle, respect for persons, means that researchers must respect the autonomy of research participants and provide protections against coercion, particularly for vulnerable populations. The second principle, beneficence, means that researchers have an obligation to enact the following rules: “(1) do not harm and (2) maximize possible benefits and minimize possible harms.”^[2] The third principle, justice, means that research participation should be distributed, rather than concentrated heavily on one population. For example, the Belmont Report references the infamous Tuskegee Syphilis Study, in which researchers “used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population,”^[3] along with a number of other serious ethical violations.^[4] Respect for persons, beneficence, and justice guide researchers in ethical research practices.

In addition to the Belmont Report, there are a number of federal agencies that have guidelines and requirements governing human subjects research.^[5] For example, the Office for Human Rights Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) all provide oversight of human subjects research. Colleges and universities like Texas A&M University have institutional review boards, or IRBs, that review research plans to ensure compliance with government regulations and ethical guidelines.^[6] Researchers, including professors and students, are required to seek and receive approval from their campus IRB before conducting human subjects research projects.

The Office for Human Rights Protections (OHRP) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”^[7] The type of research conducted in a college class for the purposes of developing research skills does not always meet the formal definition of research, because it may not be systematic or generalizable. Students should check with their course instructors to determine whether Internal Review Board (or IRB) approval is required for a course research assignment.

Regardless of whether a specific study meets the specific criteria for human subjects research, researchers at every stage of their career should adhere to the core principles of ethical behavior. Even when completing assignments and studies that do not meet the formal definition of human subjects research, researchers and students should abide by the principles of respect for persons, beneficence, and justice.

Below are three common research methods that use human subjects, along with specific ways that can help you conduct such studies ethically.

Interviews. Provide participants with information about the interview experience and have them sign an informed consent form before you begin. If you plan to record interviews, either with audio or video, ask for specific consent for the recording. Be sure to inform participants that they may skip questions that they are uncomfortable with or end the interview at any time.

Surveys/Questionnaires. At the beginning of the survey/questionnaire, provide an informed consent section that includes a description of the research project, risks and benefits, and researcher contact information. Participants must consent to participate in order to be included in the study.

Naturalistic observation in non-public venues (or field observations). In naturalistic observations, the goal is to be as unobtrusive as possible, so that your presence does not influence or disturb the normal activities you want to observe. If you want to observe activities in a specific workplace, classroom, or other non-public place, you must first seek permission from the manager of that place and let participants know the nature of the observation. Observations in public places may not require informed consent, though researchers should seek IRB approval. Photographs or videos require specific informed voluntary consent and permission.

These are the most common methods used in undergraduate courses. There are many other methods, including engaging with people and their information via social media, organizing focus groups, engaging in beta-testing or prototype trials, etc. For the purposes of your writing course, however, these other methods are generally not recommended because they involve additional ethical considerations for you and your instructor. At Texas A&M University, questions about research ethics or whether IRB approval is required for a study should be directed to the Human Research Protection Program.^[8]