Informed Consent Agreements

by Janet Salmons, Research Community Manager for SAGE Methodspace
Dr. Salmons is the author of Doing Qualitative Research Online, which focuses on ethical research and writing, and What Kind of Researcher Are You? which focuses on researcher integrity. With the code MSPACEQ322 you receive a 20% discount when you order the books from SAGE. Valid through September 30.

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Informed consent implies two related activities: participants need first to comprehend and second to agree voluntarily to the nature of their research and their role within it. …[I]n practice, the requirements of informed consent have proved to be anything but straightforward in the social sciences. (Israel & Hay, 2006).

Informed consent is meant to verify that the participant understands what is expected, including potential risks, and is willing to be a part of the study. A challenge for researchers is verification of this agreement. As with many areas of life, a proverbial handshake is not enough. When legal implications come into play, the required forms grow in length and complexity. Verbiage on forms, written by non-researchers, may require participants to have high levels of literacy or might be interpreted as coercion. As Israel and Hay note, more difficulties arise when researchers and participants do not share common languages or cultures.

Given these issues, does a signed agreement verify that someone is truly informed and willing to volunteer as a research participant? There are no simple answers to this question! This collection of open-access articles offers a variety of perspectives on the forms used for informed consent agreements.

Israel, M., & Hay, I. (2006). Informed consent. In Research ethics for social scientists (pp. 60-76). SAGE Publications, Ltd, https://dx.doi.org/10.4135/9781849209779.n5

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Araali, B. B. (2011). Perceptions of Research Assistants on How Their Research Participants View Informed Consent and Its Documentation in Africa. Research Ethics, 7(2), 39–50. https://doi.org/10.1177/174701611100700203
Abstract. This paper discusses the issue of informed consent from an African perspective with a particular emphasis on the problems posed by the documentation of consent in the African socio-cultural environment. The paper presents two small-scale surveys which typify and exemplify the African perspective with regard to procedures for obtaining consent (agreement) and for documenting it. To avoid causing moral pain to African research participants and the feeling of having been used as mere sources of data, this paper suggests, as a shortterm solution, that African cultural values be incorporated in the procedures and regulations aimed at protecting their human rights. As a long-term solution, the paper encourages universities and research institutions operating in Africa to come up with clear guidelines of ethical conduct which would satisfy both the interests of ordinary Africans (particularly the rural and uneducated population) and legal requirements to which Western research institutions and funding agencies are subjected.

Biggs, J. S., & Marchesi, A. (2015). Information for consent: Too long and too hard to read. Research Ethics, 11(3), 133–141. https://doi.org/10.1177/1747016115583381
Abstract. The length of participant information sheets (ISs) for research and difficulties in their comprehension have been a cause of increasing concern. We aimed to examine the information sheets in research proposals submitted to an Australian HREC in one year, comparing the results with national recommendations and published data. Information sheets in all 86 research submissions were analysed using available software. The work of Flesch was used for Reading Ease or Readability and that of Flesch and Kincaid for the level of education required for comprehension, the Reading Grade Level. The mean length of 86 information sheets was 3110 words; many had more than 5000 words. Using the Flesch scale of 0 to 100, with 0 meaning most difficult and 100 very easy to read, the mean readability level was 47. The mean length of education needed to easily grasp the information was 11.6 years, equivalent to senior secondary school. Information sheets in research projects submitted to an HREC were often too long to be read in a reasonable time and too difficult to be easily understood. Recommended standards for information sheets were infrequently met.

Curran, D., Kekewich, M., & Foreman, T. (2019). Examining the use of consent forms to promote dissemination of research results to participants. Research Ethics, 15(1), 1–28. https://doi.org/10.1177/1747016118798877
Abstract. It is becoming widely recognized that dissemination of research results to participants is an important action for the conclusion of a research study. Most research institutions have standardized consent documents or templates that they require their researchers to use. Consent forms are an ideal place to indicate that results of research will be provided to participants, and the practice of inserting statements to this effect is becoming more conventional. In order to determine the acceptance of this practice across Canada we conducted an assessment of 121 institutional consent document templates from 65 institutions (hospitals and universities) looking for language that endorsed results dissemination to participants. About half (51%) of the documents we examined had language included which stated that results should be made available. In an era where research participation in hospital settings and universities is becoming ubiquitous there should be a reciprocal expectation that results should be provided. The success of research should be measured in part by its accessibility and dissemination to all stakeholders.

Davies, H. (2022). Reshaping the review of consent so we might improve participant choice. Research Ethics, 18(1), 3–12. https://doi.org/10.1177/17470161211043703
Abstract. Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps:

Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.

Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.

Step 3: After a gap, if necessary, reviewing and checking understanding.

Step 4: Reaching agreement and recording consent.

These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.

Paasche-Orlow, M. K., Taylor, H. A. & Brancati, F. L. 2003. Readability Standards for Informed-Consent Forms as Compared with Actual Readability. New England Journal of Medicine, 348, 721-726.
Abstract. Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight.

Perrault, E. & Nazione, S. 2016. Informed Consent-Uninformed Participants: Shortcomings Of Online Social Science Consent Forms And Recommendations For Improvement. Journal Of Empirical Research On Human Research Ethics : Jerhre, 11.
Abstract. As informed consent forms continue to lengthen, are these lengthening forms helping to create better informed participants? The aim of this research was to determine whether the length of consent forms affected reading frequency and comprehension, and to provide recommendations on how to improve consent forms in the social sciences so they are more likely to be read. A quasi-experiment was conducted using actual consent forms at two liberal arts schools, one requiring a long form (463 words, n = 73) and one requiring a shorter form (236 words, n = 57). Participants exposed to the shorter form reported fully reading, or at least skimming the form more frequently than those exposed to the longer form. Those exposed to the shorter form also comprehended more of the form's information. The majority of participants indicated consent forms need to be shortened if researchers want future participants to be more likely to read these forms' contents. Additional recommendations are discussed.

Ripley, K. R., Hance, M. A., Kerr, S. A., Brewer, L. E., & Conlon, K. E. (2018). Uninformed consent? The effect of participant characteristics and delivery format on informed consent. Ethics & Behavior, 28(7), 517-543.
Abstract. Although many people choose to sign consent forms and participate in research, how many thoroughly read a consent form before signing it? Across 3 experiments using 348 undergraduate student participants, we examined whether personality characteristics as well as consent form content, format, and delivery method were related to thorough reading. Students repeatedly failed to read the consent forms, although small effects were found favoring electronic delivery methods and traditional format forms. Potential explanations are discussed and include participant apathy, participants trying to save time by not reading the consent form, and participant assumptions about consent forms.

Quinn SC, Garza MA, Butler J, et al. Improving informed consent with minority participants: results from researcher and community surveys. Journal of Empirical Research on Human Research Ethics : JERHRE. 2012 Dec;7(5):44-55. DOI: 10.1525/jer.2012.7.5.44. PMID: 23324203; PMCID: PMC3685140.
Abstract. Strengthening the informed consent process is one avenue for improving recruitment of minorities into research. This study examines that process from two different perspectives, that of researchers and that of African American and Latino community members. Through the use of two separate surveys, we compared strategies used by researchers with the preferences and attitudes of community members during the informed consent process. Our data suggest that researchers can improve the informed consent process by incorporating methods preferred by the community members along with methods shown in the literature for increasing comprehension. With this approach, the informed consent process may increase both participants' comprehension of the material and overall satisfaction, fostering greater trust in research and openness to future research opportunities.

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