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Principles of Human Participant Protection

It is your ethical and legal responsibility as a researcher to demonstrate that your work does not create undue harm for the people whom you involve in it, or that any harm the research may cause is balanced by the potential social benefits of the research. It is also your responsibility to design and implement procedures to interact with and collect information from human participants in an ethical way, and to manage and share the information that they provide to you in ways that are in line with the overall goals of conducting ethical research. In addition to these general expectations, in many academic contexts, research involving human participants must be submitted for formal review and approval by one or more Institutional Review Boards (IRBs) before it begins.

Three Principles of Ethical Research

Three principles of ethical research (as defined in the 1979 Belmont Report) are:

  1. Respect. In order to respect the personal autonomy of research participants, you must provide them with clear, comprehensible, comprehensive, and accurate information about the research project in which you are inviting them to participate and about any risks participating might imply for them. Participants must be able to decide voluntarily whether to begin participation, and when to end it (i.e., participants must be able to freely choose to withdraw). You need to apply special care where the participant population might have diminished autonomy (e.g., children, people with diminished cognitive capacity due to age or a medical condition).
  2. Beneficence. You should design your research to minimize potential risks to individual participants while maximizing benefits to society. You should identify and strike an ethical balance between the immediate benefits and risks for project participants, and also consider the balance between long-term/society-wide risks of the project and its benefits (e.g., enhancing knowledge and developing novel social or political procedures or processes). An ethical conundrum for social science research is that it sometimes presents more than minimal risk without immediate, direct, or indirect benefit to participants. You should document such situations clearly as your project progresses.
  3. Research must be fair to individual participants; it must neither exploit nor ignore one group to benefit another (as, for example, in the Tuskegee syphilis study). Conversely, excluding potentially eligible participants from a study on the basis of social, racial, sexual or cultural biases and without a scholarly justification is also unacceptable. This principle comes into play most directly when you are identifying the study population and selecting study participants. You should strive to ensure that choices are made on a scholarly, substantive basis, and not based on factors such as individuals’ availability, manipulability, or other vulnerability.

Belmont Report Passage
A passage from the original edition of the Belmont report. Source: archive.org

You should keep these principles in mind and apply them through every phase of research projects that involve interacting with human participants – from assessing the risk/benefit to individuals of participating in the project; to selecting participants; to obtaining informed consent for their participation; to actually collecting information from them; to managing, using, sharing, and considering the potential re-use of the data in the future.

Three Key Concepts Related to Data Collected from Human Participants

Three key terms – related but distinct – that are invoked in conversations regarding human participants and concerns about protecting them are:

  • Privacy: The right of individuals to limit access to aspects of their person such as thoughts, identifying information, and biological and genetic information; privacy is sometimes considered a human right.
  • Sensitivity: An attribute of data; medical and financial data as well as other personal data protected by state and federal law are examples of sensitive data; whether or not, or the degree to which, data are considered sensitive may differ by context.
  • Confidentiality: Concerns the way in which information is conveyed and limitations that the source may put on its use and further dissemination; information that someone has disclosed in a relationship of trust is confidential and can be shared only with that person’s permission.

Assessing Benefits and Risks to Participants

You may find it challenging to identify the direct benefits that accrue to individuals as a result of participating in your project (as opposed to the generalized social, political, and/or intellectual benefits of your research). We suggest that you think broadly, considering not only how your work may help particular participants, but how it might benefit specific groups, institutions, or organizations of relevance to that participant, such as government agencies, businesses, political parties.  Also consider what effects it might have at the local, state, national, or international level; and how it could help particular polities or societies understand themselves and potentially make positive changes.

When you are considering the risk that participating in your research project might entail, it can be useful to establish a baseline of ordinary risk, and to assess the risk of taking part in your project against that baseline. Be particularly alert to the question of whether potential disclosure of any participant’s responses might expose them to:

  • criminal/civil liability, or
  • damage to their financial standing, employability, or reputation.

Here is how the U.S. National Science Foundation ranks the sorts of risk that might arise from research situations:

  • Harms commensurate with daily life, requiring no special protection:
    • Mere inconvenience [such as] when a survey or other research interaction is administered at an inconvenient time or place or simply takes a long time to administer.
  • Harms that have the potential for serious effects, which IRBs should examine:
    • Emotional or psychological harm, for example when a research interaction causes upset, or worry about breach of confidentiality.
    • Social harm due to stigma or other negative social outcomes of breach of confidentiality.
    • Physical harm if revelations [a participant makes about other persons] get back to those persons, particularly when researchers study domestic violence, gang activity, political activity in a conflict zone, or other phenomena concerning violence-prone individuals.
    • Financial harm if information conveyed by a participant may result in loss of employment or insurance coverage.
    • Legal harm when illegal activities are disclosed by a participant.
    • Moral harm when participation in research strengthens subjects' inclinations to behave unethically.”