Informed consent documents generally serve two purposes: provide information to participants about the research and to protect institutions and sponsors from liability. As a result, sponsors and IRBs may not permit changes to template consent forms that they provide. In contrast, the Federal Regulations require that key information is specifically designed to enhance understanding of the main reasons a person would or would not want to take part in research. The Federal regulations require that information be “organized and presented in a way that facilitates comprehension.” As a result, IRBs and Sponsors should provide more flexibility in making changes to key information documents that maximize comprehension.

Most IRBs and Sponsors provide templates, and these may or may not include guidance on formatting or using plain language. If your IRB or Sponsor has provided you with a template, we recommend that you address the key content they require (for instance, purpose of research, benefits, risks, alternatives), while incorporating our tips on formatting and plain language.

IRBs and Sponsors may not be familiar with these best practices, but they are evidence-informed and have been shown to increase comprehension. Our toolkit contains sample text you can use to justify why you have incorporated evidence-informed communication strategies into your key information sheet for your IRB or Sponsor. As we describe in the above FAQ, IRBs should provide more flexibility with key information since Federal Regulations require they be organized to maximize comprehension.

Using plain language involves writing in a simple and clear manner. This requires using lay language, avoiding technical jargon and terms that are difficult to understand, even when describing a complex clinical trial. Using plain language may be challenging especially for research professionals who are experts in their area and may prioritize accuracy of information over simple language. You may feel that using plain language leads to loss of nuance or meaning but evidence suggests that basic words are more easily understood for the vast majority of individuals. It may be helpful to remember that over half of US adults have basic or below basic literacy, and using plain language is an evidence-informed practice that increases understanding of information. Remember: The full informed consent form also provides space for further details and precision.

The Revised UBACC is a validated tool to assess whether a potential participant understands informed consent information prior to enrollment. It can be reliably administered in about 5 minutes with minimal training by Bachelor’s degree-level staff.

There is wide variation among clinicians when making individual determinations about participant understanding. Therefore, using a validated assessment with all participants avoids the need for researchers to use their individual judgment when deciding whether a potential participant has understood the research before consenting. The Revised UBACC provides a set of objective criteria to assess participants. It ensures that everybody understands and appreciates the study they are participating in, and helps researchers from wrongly assuming that participants understand the information that was presented to them.

Validated assessments are designed to ensure that specific aspects of providing informed consent to research – such as understanding, appreciation, and expressing a choice – are evaluated. These specific aspects of decision making may not be familiar to most researchers and therefore may not be assessed when using informal clinical judgement.

The Revised UBACC is specifically designed to address whether an individual has understood the particular study they are being asked to consent to. Questions are tailored to the specific study, for instance by asking participants to state the main risks or benefits in their own words. Assessments like the Montreal Cognitive Assessment (MOCA) or Mini Mental State Exam (MMSE) are global assessments of cognitive function to determine if an individual has signs of cognitive decline that may be due to an underlying condition, such as dementia. The MOCA and MMSE are not designed to assess whether an individual has understood a particular study prior to enrolling.

Using a study specific assessment like the UBACC helps ensure that a participant understands the study they are being asked to take part in, rather than whether they have cognitive decline or decisional impairment more generally. Individuals with diminished cognitive function as determined by the MMSE or MOCA may still be able to understand an individual study and make the decision to take part. This can be assessed using the Revised UBACC.

The role of an LAR is to make research participation decisions on behalf of a participant who can no longer decide for themselves. LARs may also be called proxies or surrogate decision makers. The majority of older adults support the idea of letting a person they designate make research decisions on their behalf.^1-3

Nevertheless, researchers have expressed concerns that an LAR could make a decision on behalf of a participant that might not align with what the participant would have wanted. This may lead to uncertainty or hesitation in appointing an LAR.

There are two broad ethical approaches to decision making on behalf of a research participant. The first is substituted judgement, which refers to making decisions based on what the participant would have wanted. In some cases, a participant might have stated their wishes about participating in a particular study before their decision-making capacity is compromised. For instance, if a participant becomes impaired during the course of a study for which they already consented, an LAR could reasonably presume to know the participant’s wishes about this particular study (using “substituted judgment”). However, in many cases it may not be possible to know what a participant would have decided about a particular research study if it was never discussed before. And some data indicate that LARs are not always good at predicting what a participant would have wanted.¹ This indicates that substituted judgment may be difficult in practice.

The second standard is “best interest”, which refers to making decisions that are in the best interests of the participant given what we know about the participant and the study. In reality, decision making will likely include elements of both. LARs may make decisions that take into consideration what we know about a participants’ prior wishes, values, and the risks and benefits of this particular study. Importantly, most LARs are likely to know the participant well and have a close relationship with them.⁴ Notably, evidence indicates that individuals are willing to allow their surrogate decision makers “some or complete leeway” in making research decisions; this suggests that the hybrid model that many people may use, may also be acceptable to participants.³

However, a third approach is possible: An LAR may make decisions that best serve their own interests. In such cases, it might make sense to advocate for a participant’s best interests or known wishes.

1. Abdoler E, Wendler D. Using data to improve surrogate consent for clinical research with incapacitated adults. Journal of empirical research on human research ethics : JERHRE. 2012;7(2):37-50.
2. Kim SYH, Kim HM, McCallum C, Tariot PN. What do people at risk for Alzheimer disease think about surrogate consent for research? Neurology. 2005;65(9):1395-1401.
3. Kim SY, Kim HM, Langa KM, Karlawish JH, Knopman DS, Appelbaum PS. Surrogate consent for dementia research: a national survey of older Americans. Neurology. 2009;72(2):149-155.
4. Kim SY, Karlawish JH, Kim HM, Wall IF, Bozoki AC, Appelbaum PS. Preservation of the capacity to appoint a proxy decision maker: implications for dementia research. Arch Gen Psychiatry. 2011;68(2):214-220.

Not all studies open to older adults (age 65+) will require the use of Legally Authorized Representatives (LARs). A major determinant of whether LARs are necessary is the risk level of the research study. As the risk level of a study increases, so too does the need to ensure participants and their LARs have adequate understanding.

Additional factors to consider are whether your study requires multiple visits. A one-time interaction may not require the use of an LAR. In contrast, a multi-year study where capacity to consent may change over the course of the study would justify the use of an LAR when the risk level justifies it.

1. Microsoft Word Help Center is a free online resource with guidance on formatting, layout, and inserting tables.
2. GCFGlobal.org program is a free program aimed to help people learn essential work skills. They have a free online training on word processing and many other related topics.
3. LinkedIn Learning – Some universities are partnered with LinkedIn Learning (formerly Lynda.com). If your university is partnered with LinkedIn Learning then you may be able to access this online educational platform for free. The platform contains educational videos on learning word processing. 

Here are links to peer-reviewed articles, federal regulations, and other documents we reference in each of our videos.

Informed Consent

1. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986.
2. Iltis AS, Misra S, Dunn LB, et al. Addressing Risks to Advance Mental Health Research. JAMA : the journal of the American Medical Association. 2013;70(12):1363-1371.
3. DuBois JM, Beskow LM, Campbell J, et al. Restoring Balance: A Consensus Statement on the Protection of Vulnerable Research Participants. American journal of public health. 2012;102(12):2220-2225.
4. Dubois JM, Bailey-Burch B, Bustillos D, et al. Ethical issues in mental health research: the case for community engagement. Current opinion in psychiatry. 2011;24(3):208-214.

Federal Regulations, policies, or guidelines

1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Washington, D.C.: United States Department of Health, Education, and Welfare; April 18, 1979.
2. National Institutes of Health. Inclusion Across the Lifespan Policy. 2019.
3. Menikoff J, Kaneshiro J, Pritchard I. The Common Rule, Updated. New England Journal of Medicine. 2017;376(7):613-615.
4. New “Key Information” Informed Consent Requirements. In: The Secretary’s Advisory Committee on Human Research Protections, ed. Attachment C
5. Research Involving Individuals with Questionable Capacity to Consent: Points to Consider. In: National Institutes of Health, ed. 2009.
6. Centers for Disease Control and Prevention. Health Literacy. 2019
7. Government US. Federal Plain Language Guidelines.
8. Mark Kutner EG, Justin  National Assessment of Adult Literacy (NAAL). National Center for Education Statistics. 2005.
9. Health Literacy: A prescription to end confusion. Institute of Medicine of the National Academies. 2004.
10. The Plain Language Action and Information Network. Plain Language. 2019

Cognitive Impairments

1. Grisso T, Appelbaum PS. Assessing competence to consent to treatment : a guide for physicians and other health professionals. New York: Oxford University Press; 1998.
2. Appelbaum PS, Roth LH. Competency to consent to research: a psychiatric overview. Archives of General Psychiatry. 1982;39(8):951-958.
3. Centers for Disease Control and Prevention. Cognitive impairment: A call for action, now! Atlanta, GA: CDC; February 2011.
4. Stewart RA, Liolitsa D. Type 2 diabetes mellitus, cognitive impairment and dementia. Diabetic Medicine. 1998;16:93-112.
5. Sinclair AJ, Girling AJ, Bayer AJ. Cognitive dysfunction in older subjects with diabetes mellitus: impact on diabetes self-management and use of care services. Diabetes Research and Clinical Practice. 2000;50:203-212.
6. Schmidt R, Fazekas F, Offenbacher H, et al. Magnetic Resonance Imaging White Matter Lesions and Cognitive Impairment in Hypertensive Individuals. Archrives of Neurology. 1991;48:417-420.
7. Vogels RLC, Scheltens P, Schroeder-Tanka JM, Weinstein HC. Cognitive impairment in heart failure: A systematic review of the literature. European Journal of Heart Failure. 2007;9:440–449.
8. Palmer BW, Ryan KA, Kim HM, Karlawish JH, Appelbaum PS, Kim SY. Neuropsychological correlates of capacity determinations in Alzheimer disease: implications for assessment. Am J Geriatr Psychiatry. 2013;21(4):373-381.
9. Alzheimer’s Association. Research consent for cognitively impaired adults. Alzheimer Disease and Associated Disorders. 2004;18(3):171-175.
10. Barstow C, Shahan B, Roberts M. Evaluating Medical Decision-Making Capacity in Practice. Am Fam Physician. 2018;98(1):40-46.
11. Wendler D, Prasad K. Core Safeguards for Clinical Research with Adults Who Are Unable To Consent. Ann Intern Med. 2001;135(7):514-523.

Older Adults general and Inclusion in Clinical Trials

1. Pierce R. A changing landscape for advance directives in dementia research. Social science & medicine. 2010;70(4):623-630.
2. Taylor JS, DeMers SM, Vig EK, Borson S. The disappearing subject: exclusion of people with cognitive impairment and dementia from geriatrics research. Journal of the American Geriatrics Society. 2012;60(3):413-419.
3. de Jonghe A, van de Glind EM, van Munster BC, de Rooij SE. Underrepresentation of patients with pre-existing cognitive impairment in pharmaceutical trials on prophylactic or therapeutic treatments for delirium: a systematic review. J Psychosom Res. 2014;76(3):193-199.
4. Herrera AP, Snipes SA, King DW, Torres-Vigil I, Goldberg DS, Weinberg AD. Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change. Am J Public Health. 2010;100 Suppl 1:S105-112.
5. Stanley B, Guido J, Stanley M, Shortell D. The elderly patient and informed consent. Empirical findings. 1984;252(10):1302-1306.

Evidence that most do not understand consent and Evidence Informed Consent Practices

1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA : the journal of the American Medical Association. 2000;283(20):2701-2711.
2. Paasche-Orlow MK, Brancati FL, Taylor HA, Jain S, Pandit A, Wolf M. Readability of consent form templates: A second look. 2013;35(4):12-19.
3. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine. 2003;348:721-726.
4. Flory J, Emanuel EJ. Interventions to Improve Research Participants’ Understanding in Informed Consent for Research: A Systematic Review. JAMA : the journal of the American Medical Association. 2004;292(13):1593-1601.
5. Resnik DB. Do informed consent documents matter? Contemp Clin Trials. 2009;30(2):114-115.
6. Montalvo W, Larson E. Participant Comprehension of Research for Which They Volunteer: A Systematic Review. J Nurs Scholarsh. 2014;46(6):423-431.
7. Dubois JM, Bante H, Hadley WB. Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects. AJOB primary research. 2011;2(4):5-17.
8. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving Understanding in the Research Informed Consent Process: A Systematic Review of 54 Interventions Tested in Randomized Control Trials. BMC medical ethics. 2013;14:28.
9. Kim EJ, Kim SH. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level. Clinical trials. 2015;12(3):232-236.
10. Agre P, Campbell FA, Goldman BD, et al. Improving Informed Consent: The Medium is Not the Message. IRB: Ethics & Human Research. 2003;Suppl 25(5):S11-S19.
11. Campbell FA, Goldman BD, Boccia ML, Skinner M. The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: a comparison of print, video, and computer-based presentations. Patient Education and Counseling. 2004;53(2):205-216.
12. Rudd RE CJ, Hyde J. Leave no one behind: Improving health and risk communication through attention to literacy. J Health Commun. 2003;Special Supplement on Bioterrorism (8 (Supplement 1)):104-115.

Evidence Regarding IRBs

1. Stark L. Behind closed doors: IRBs and the making of ethical research. Chicago: University of Chicago Press; 2012.
2. Gong MN, Winkel G, Rhodes R, Richardson LD, Silverstein JH. Surrogate consent for research involving adults with impaired decision making: Survey of Institutional Review Board practices. Critical care medicine. 2010;38(11):2146-2154.

Validated Assessments

1. Jeste DV, Palmer BW, Appelbaum PS, et al. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007;64(8):966-974.
2. Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, Saks ER. Assessing decisional capacity for clinical research or treatment: a review of instruments. The American journal of psychiatry. 2006;163(8):1323-1334.

Legally Authorized Representatives (LAR)

1. Kim SY, Kim HM, McCallum C, Tariot PN. What do people at risk for Alzheimer disease think about surrogate consent for research? 2005;65(9):1395-1401.
2. Kim SY, Kim HM, Langa KM, Karlawish JH, Knopman DS, Appelbaum PS. Surrogate consent for dementia research: a national survey of older Americans. 2009;72(2):149-155.
3. Kim SY, Uhlmann RA, Appelbaum PS, et al. Deliberative assessment of surrogate consent in dementia research. Alzheimer’s & dementia : the journal of the Alzheimer’s Association. 2010;6(4):342-350.
4. De Vries R, Ryan KA, Stanczyk A, et al. Public’s Approach to Surrogate Consent for Dementia Research: Cautious Pragmatism. Am J Geriatr Psychiatry. 2013;21(4):364-372.
5. Pope TM. Unbefriended and Unrepresented: Better Medical Decision Making for Incipacitated Patients without Healthcare Surrogates. Georgia Law Rev. 2017;33(4):923-1019.
6. Karlawish J, Kim SY, Knopman D, van Dyck CH, James BD, Marson D. The views of Alzheimer disease patients and their study partners on proxy consent for clinical trial enrollment. Am J Geriatr Psychiatry. 2008;16(3):240-247.
7. Kim SY, Karlawish JH, Kim HM, Wall IF, Bozoki AC, Appelbaum PS. Preservation of the capacity to appoint a proxy decision maker: implications for dementia research. Arch Gen Psychiatry. 2011;68(2):214-220.

Study Partners

1. Black BS, Taylor HA, Rabins PV, Karlawish JH. Study partners perform essential tasks in dementia research and can experience burdens and benefits in this role. Dementia (London, England).

Here are links to web-based materials we reference in each of our videos.

Writing Key Information Using Plain Language Video

www.plainlanguage.gov

www.cdc.gov