Working With Human Subjects

Informed Consent

What is informed consent? Before someone can agree to participate in a research project, that person needs to understand just what will be required in the research. We can understand why someone who agrees to have blood drawn or to have an invasive medical procedure needs to understand the risks and benefits involved, but even in research that doesn’t appear to pose any risk, subjects have a right to understand what they are being asked to do.

Informed consent has become a bedrock principle for research using human subjects based on research in past projects that denied key information to the subjects. As a result, subjects in the Tuskeegee syphilis study, for instance, received no treatment for the disease, put partners at risk, and ultimately died under horrific circumstances. Participants in the Milgram experiments suffered psychological trauma after they administered what they believed were fatal levels of electrical shock to other “participants” in the experiment. In these and other cases, subjects were victimized by the research. Bernie Rollins, ethics professor at CSU, contextualizes ethical issues in human subject research at http://web.research.colostate.edu/rcr/Default2.aspx.

The IRB provides information about and a template for consent forms at http://web.research.colostate.edu/ricro/hrc/forms.aspx. It’s worth taking the time to consider what constitutes informed consent and why getting consent fulfills ethical considerations for human subjects, so let’s look at key points on the template.

Title: The title of your project as it appears on the consent form will be the same as the project title approved on the e-protocol. The title should indicate the focus of your project, though you may well discover after completing your data analysis that you want to change the title of your thesis or project report. That’s no problem so long as all the work relating to data collection uses the title of the approved research protocol.

Purpose: Students sometimes worry that if they disclose too clearly the purpose of the research they will initiate the Hawthorne effect so that subjects report data to confirm researchers’ goals. Remember, however, that little research is conducted to substantiate a foregone conclusion. Rather, most research investigates, so researchers can certainly explain in brief what the focus of the research is and why it matters.

Jared Tomlin in 2004 noted this purpose for his research: “Information collected in this study may help teachers to develop more effective writing heuristics, provide necessary resources to facilitate student writing, and improve our understanding of the complexity of the writing process.” The general description of the purpose would not help even the most suggestible subjects know just what responses “would make the researcher happy.”

What will I be asked to do?: In this section, lay out clearly but briefly what you expect participants to do. Again, Jared Tomlin’s project gives a good example of a crisp description of procedures: “Study participants will complete surveys about their writing processes at the beginning, middle, and end of the semester, each taking approximately 10 minutes to complete. The students selected for case studies will participate in three one-hour writing sessions, some involving protocol analysis, where they will be videotaped and asked to speak aloud while writing, as well as three one-hour, audiotaped interviews throughout the semester.”

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life. Most of our research projects involve no risk, but in some studies, breach of confidentiality can pose minimal risk to participants. Be sure to evaluate risk factors carefully and to be clear about what you will do to protect subjects from even minimal risk. If your project involves more than minimal risk, then you need to be explicit about how you will safeguard participants and how the benefits to them balance such risks.

Benefits might not accrue to the participants of the project itself; rather, benefits from the study might apply to a larger group of people at a later time. In many projects in English studies, the benefits show up for students in other classes as teaching methods get refined over time. In other projects, data collected in one site is transferred to help writers in another site. Be realistic about immediate benefits to your subjects (“you might learn more about your own writing process”) as well as larger benefits to other groups.

Confidentiality: Because we characterize writers and their writing in much of our research, maintaining confidentiality is among the most important safeguards for human subjects. Although few researchers will indulge in pointedly hurtful characterizations, writers might well be uncomfortable with almost any label applied to their writing. Consider, for instance, how we might refer to freshman composition students: “introductory” is less loaded than “beginning” which in turn is more positive than “naïve.” None of these terms is negative when applied to writing, yet subjects in research might feel stigmatized if their participation in research characterized this way were to be revealed. Safeguarding confidentiality, particularly if you collect private information that can identify a particular subject, is a key element in obtaining consent, so any possible breaches of confidentiality must be disclosed on a consent form.

In their “tips,” the IRB notes these guidelines for an easy-to-read Informed consent document:

  1. Use the newly revised consent template on the RICRO website.
  2. Use words that are familiar to all the participants; define any uncommon words.
  3. Use the same words or phrases consistently.
  4. Make sentences short and simple.
  5. Use short paragraphs, conveying one idea per paragraph.
  6. Make the document in “you” format.
  7. Underline, bold or boxes to emphasize text rather than all caps or italics.
  8. Readability of the document should be at the 6th-8th grade reading level.
  9. Avoid using acronyms or abbreviations.
  10. If applicable, place compensation, i.e., t-shirt, gift certificate, etc., in the procedures section or a separate compensation section.
  11. If there are no known benefits to the participant from the research, state this. For example, “There are no known benefits in participating, but we hope you will...”
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Introduction