What is included in an informed consent document?

[su_dropcap style="flat" size="4" class=""]T[/su_dropcap]he federal research regulations (45 C.F.R. § 46.116 (a)(5)(i)) stipulate that consent forms must first concisely describe key information about the study that prospective participants will likely want to know to make an informed decision about participation before providing more detailed information about the research. The federal research regulations (45 C.F.R. § 46.116 (b)) also list the required information to include in informed consent forms:

• Describe that the prospective participant is being asked to participate in research. You should include information to differentiate the research activities from any services the prospective participants may currently receive at the same place that is conducting the research.

• State the purpose of the research. You should use lay language and nonscientific terms to describe what you are aiming to discover.

• Describe all the procedures that will be used in your research, painting a picture of what the individuals will experience if they decide to participate. This description should also indicate which procedures are experimental (such as whether the study will test the effectiveness of a new educational intervention) and whether participants will be randomly assigned to an intervention or control group. You should also indicate the time commitment required of participants (such as the hours spent completing surveys) and how long participation will last (e.g., at what point a longitudinal study will end).

• Describe all reasonably foreseeable risks or discomforts that may arise from participation (see Questions #11 and #12). Discussion of risks should not reflect the “worst case scenario” but rather focus on those risks that are most likely to occur and those that are likely important to an individual’s decision about participating.

• Present the potential benefits of the research, including benefits to participants and benefits to others (see Question #14). You must take care not to overstate the potential benefits, particularly with experimental interventions as they do not yet have sufficient evidence of benefit (see Question #16).

• When applicable, describe any alternatives to participating in the research. This will apply only in research that is evaluating an intervention in some way. It must be clear to prospective participants whether they can receive the intervention or a similar intervention without participating in the research, or if participating in the research is the only way to receive this type of intervention. For example, if a psychology researcher is conducting a study to compare the effectiveness of two smoking cessation programs, the consent form should list smoking cession programs that are available outside of participating in the research, including whether the specific interventions offered in the research are available outside of the research. This helps participants to understand that research participation is not their only option.

• Describe the steps that you will take to protect the confidentiality of data collected during the research (see Question #23).

• Describe any financial compensation for research participation (see Questions #57 and #58). Compensation should not be presented as a benefit of research participation, but rather as an incentive or reimbursement for costs incurred (such as travel costs or time).

• Stress that research participation is voluntary (see Question #49). Prospective participants should be assured that they will not be penalized if they choose not to participate or if they stop participating after they are enrolled in the research. For example, individuals refusing or stopping participation should not lose any standard services provided by the institution where the research is being conducted.

• State whom participants can contact if they have questions about the research (usually the lead researcher) and if they have complaints, for example, if they feel they have been mistreated or misled in the research (usually the institutional review board [IRB] that provides oversight for the study). Names, telephone numbers, and emails of these individuals should be listed.

• Include one of two statements on the use of personal identifiers or identifiable biospecimens, if these are collected as part of the research:

1. that information and/or biospecimens collected in this research may be used by other researchers after all identifiers are removed; their additional consent would not be sought, or

2. that information and/or biospecimens collected in this research will not be used in other research, even if identifiers are removed.

The federal research regulations (45 C.F.R. § 46.116 (c)) describe that other information should be included if applicable, such as:

• the number of participants who will be involved in the study, if known, and

• a description of the circumstances under which an individual’s participation may be terminated by the researcher. For example, it may be reasonable to state that people may be asked to leave a focus group discussion if they are rude or combative.

In certain circumstances, an IRB may approve the exclusion of one or more of the required elements from a consent form.Additionally, most institutions have informed consent templates with required or suggested language that can be adapted to specific studies.Researchers are ethically bound by the federal research regulations to be truthful in the information they present in consent forms and not to include any statements that appear to waive participants’ legal rights (such as their right to sue the institution in the event of personal injury) or to release the investigator, institution, or research sponsor from liability (such as for negligence). Additionally, the informed consent form is often mistaken to be a legally binding contract because it includes technical and legal-sounding language, and participants are typically required to sign it. However, a consent form is not a legally binding contract. Participants are not required by law to comply with what they are asked to do in a consent form just because they have signed it, and they can stop participating in the research study at any time without penalties or other consequences. This is what makes a research consent form different from a legally binding contract.

This material is drawn from the SAGE Publishing text 100 Questions (and Answers) About Research Ethics by Emily E. Anderson of Loyola University Chicago and Amy Corneli at the Duke University School of Medicine. The book is a guide for graduate students and researchers in the social and behavioral sciences. It identifies ethical issues that individuals must consider when planning research studies as well as provides guidance on how to address ethical issues that might arise during research implementation. Questions such as assessing risks, to protecting privacy and vulnerable populations, obtaining informed consent, using technology including social media, negotiating the IRB process, and handling data ethically are covered.

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