Informed Consent and Privacy

Nursing research is concerned with people; therefore, the subjects of study are typically human beings. The term human subject refers to a living individual about whom an investigator conducting research obtains information or biospecimens through intervention or interaction, and uses or analyzes this information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Researchers must respect people’s rights and dignity. A key element of this is respecting autonomy—the individual’s right to make their own choices and take actions free from coercion. Of fundamental importance here is the concept of informed consent. This means that researchers obtain and document a participant’s agreement to take part in a study after providing sufficient information that could reasonably affect their decision.

A norm of voluntary participation is presumed in all nursing research. In other words, researchers cannot force anyone to participate without that person’s knowledge or consent—so much for that Truman Show experiment (“The Truman Show,” 2025)! Researchers must therefore design procedures to obtain subjects’ informed consent to participate in their research. Informed consent is defined as a subject’s voluntary agreement to participate in research based on a full understanding of the research and of the possible risks and benefits involved. Although it sounds simple, ensuring that informed consent is truly obtained is a much more complex process than you might initially think!

The first requirement is that, in giving their informed consent, participants may neither waive nor even appear to waive any of their legal rights. Beyond the legal considerations, most institutional review boards (IRBs) or research ethics boards (REBs) require researchers to share some details about the research purpose, potential benefits of participation, and, most importantly, possible risks associated with participating in that research. Researchers must also describe how participants’ identities will be protected, how and for how long data will be collected and stored, and whom to contact for additional information about the study or participants’ rights. This information is typically shared with participants in an informed consent form. In some cases, participants are asked to sign the consent form to indicate that they have read and fully understand its contents. In other cases, participants are provided a copy of the form and researchers are responsible for making sure that subjects have read and understand the form before data collection begins.

One last point to consider when preparing to obtain informed consent is that not all potential research participants are equally competent or legally able to consent. These individuals are sometimes referred to as members of vulnerable populations—people who may be at risk of undue influence or coercion.

Consent rules are more stringent for vulnerable populations. For example, minors require the consent of a legal guardian, though age-appropriate consent forms may also involve the minor in the decision-making process. Prisoners and parolees are also considered vulnerable due to the risk that they may perceive participation as linked to a desirable reward, such as early release. Another concern is that vulnerable populations may be underrepresented in research and denied potential benefits due to concerns about their ability to consent.

Researchers must take extra care to ensure consent procedures for vulnerable populations are non-coercive, and the approval process for such research may be more rigorous than for non-vulnerable populations. At the same time, researchers must avoid excluding individuals solely because they are vulnerable, as this could deny them potential benefits. Awareness of these ethical considerations is crucial for identifying appropriate solutions in each research context.

Another key aspect of respecting people’s rights and dignity is protecting their privacy—their ability to decide or control what personal information is shared with others. This requires researchers to uphold and maintain confidentiality, meaning they agree not to disclose participants’ personal information without their consent or a legally valid reason. Ideally, researchers can go a step further by ensuring anonymity, where no names or other personally identifying details are collected at all, making it impossible to link data back to individual participants.

Remixed from:

• Research methods in psychology (4th ed.) by Dr. Rajiv Jhangiani, Dr. Carrie Cuttler, and Dr. Dana C. Leighton, KPU. (2019). Published under a CC BY-NC-SA 4.0 license.
  • Chapter 15: Moral Foundations of Ethical Research

• Quantitative Research Methods for the Applied Human Sciences, by Peter Morden (2024) published under a CC BY-NC-SA 4.0 license.
  • Chapter 1: Introduction

Media Attributions

• Figure 3.1 Participant feeling pressured to sign a consent form vs. participant signing a consent form after having time to review the document with thorough informed consent. is by Ime Stavinga/TRU Open Press and is subject to the CC BY-NC-SA 4.0 license.
• Figure 3.2 is by Ime Stavinga/TRU Open Press and is subject to the CC BY-NC-SA 4.0 license.

References

Gregson, K. & Stavinga, I. (2025, November 8). Interview with Christina Hamaguchi on working with vulnerable populations [Video]. YouTube. https://www.youtube.com/watch?v=sTSBMjpbETw

Gregson, K. & Stavinga, I. (2025, October 29). Research ethics with Dr. Tracy Hoot [Video]. YouTube. https://www.youtube.com/watch?v=_crZkfLEcxs

Jhangiani, R. S., Chiang, I.-A., Cuttler, C., & Leighton, D. C. (2019). Research methods in psychology (4th ed.). Kwantlen Polytechnic University. https://kpu.pressbooks.pub/psychmethods4e/

Morden, P. (2024, December 9). Quantitative research methods for the applied human sciences. Concordia University Library. https://opentextbooks.concordia.ca/quantitativeresearch/

The Truman Show. (2025, November 3). In Wikipedia. https://en.wikipedia.org/wiki/The_Truman_Show