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Informed Consent Forms: Key Elements and Best Practices for Clinical Studies

Informed consent form is a process in which competent participants, after receiving and comprehending all research-related information, can voluntarily express their intention to participate in a clinical trial. While clinical trials identify the safety and efficacy of the investigational product,1 the primary goal of IC is to safeguard the patients or participants being recruited in these trials and ensure that they have received the information they need to know about what they are getting themselves into.

Role of Language for Effective Informed Consent Form

A language-based approach to creating and interpreting informed consent forms

The patient information sheet attached with the informed consent form (ICF) suggests that the principal investigator informed the individual in every detail about their involvement in the research procedures.2 In simpler terms, the main purpose of the ICF is to inform the prospective participants in a clinical trial that they are “subjects of research” rather than actual patients. Additionally, to take the voluntary decision, the information contained in the ICF must be understandable to the prospective participant or the representative.3 Therefore, the language of ICF plays a major role in the consent process.

Understanding Significance of Informed Consent Forms in Clinical Trials

As per 21 CFR 50.20, ‘no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative’.3

The consent procedure must correspond to the specific organization regulations for clinical trials as well as the patient’s right to autonomy. Both the investigator overseeing the clinical research and the volunteers are protected by laws and consent rules. An Institutional Review Board (IRB) often keeps an eye on how ethical guidelines are followed during the planning and execution of studies.4

One of the most significant advancements in the area of ethics about biomedical research involving human beings in the last five to six decades has been the acknowledgment of the moral right of research subjects to make their own choice, to self-determine, or to decide on the study’s involvement. These three elements are the key to the ICF.5

The collaborative nature of the ICFs is another crucial aspect, which enables participants and the investigator to agree on multiple reasonable options while taking into account the participant’s particular preferences and priorities and the best available specific evidence.4

Participants’ Decision-Making Influenced By Language

The language of ICFs is bringing a new debate about whether it should be universally understandable, as it is quite difficult for participants from different regions and without prior knowledge of clinical trials or research to comprehend the information or rules. However, even english speakers struggle to grasp the language of ICFs; imagine how difficult it would be for persons with limited English proficiency.

The impact of language about key information and financial implications was determined in a research investigation in which the participants respond, with higher frequency to understand the compensation for injury process specific to the trial in tailored ICFs compare with the standard one. The findings of this study suggested that refining ICFs to clarify the key information to the participants in the context of comparative effectiveness trials is beneficial to improving study comprehension more easily.7

In addition, according to both the United States (US) Food and Drug Administration (FDA) and the US Department of Health and Human Services (DHHS), it is mandatory to translate the ICFs for all participants with limited English proficiency. The ICF must meet the requirement of these both agencies according to the following guidelines: 6,8

Per FDA Regulation:

  • 21 CFR 50.20
  • 21 CFR 50.25
  • 21 CFR 50.27

Per DHHS:

  • 45 CFR 46.116
  • 45 CFR 46.117

In clinical trials conducted under the FDA guidelines, the ICF must comply with 21 CFR 50.20 and comprise the information needed by each of the eight fundamental aspects of 21 CFR 50.25(a) and each of the six aspects of 21 CFR 50.25(b) that apply to the investigation. However, the IRBs have the last say on whether the information in the ICF is enough.8 Moreover, the information in the ICFs must be given a lay language that can be easily comprehended by the participant with no prior knowledge and should be given in writing for the majority of the time.

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Summary

Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin
Clinical Protocol should be submitted for each planned clinical
The standard Lorem Ipsum passage, used since the 1500s
Section 1.10.32 of "de Finibus Bonorum et Malorum", written by Cicero in 45 BC
1914 translation by H. Rackham

Significance of Communication in Building Participant-Investigator Bond

Communication in healthcare settings demands specialized advanced communication skills, as well as an increased awareness of oneself and others. When the participant and investigator speak different languages, the informed consent procedure becomes more complicated since the informed consent. Discussion must be completed either in the patient’s native language or through an interpreter.

As we discussed above, the language of the ICF must be easy or lay to understand; this also applies while interpreting the information to the participants. The discussion or interpretation of the information of the ICF between the investigator in charge and the participants must be in simpler terms instead of speaking complicated medical terms. To make communication more effective, there are a few things that can be done, which includes:9

  • Establishing rapport with the participants
  • Obtaining permission for the discussion and preparing the participants prior to the discussion
  • Gathering information about the patient’s perspective
  • Providing information about clinical research procedures and their role in it
  • Discuss the next steps that will be done after their enrollment

These things are essential to have clear and effective communication between the healthcare provider and the participant during the interpretation of the ICF information or rules.

And What Would be the Implications of Doing So?

Clear, concise, and easy communication between the investigator and the participants empowers the participant’s comprehension of information and their ability to make informed decisions about their enrollment and involvement in the clinical research, knowing the potential risks and benefits involved.

Furthermore, ICF is consistent with ethical values which promotes transparency, honesty, and respect for participants’ decisions. It guarantees that the participants’ well-being takes first place above society’s concerns. Besides, to maintain conformity with ethical and legal norms, regulatory authorities such as FDA require researchers to seek informed consent from the participants. Noncompliance from the investigator’s end might have substantial implications, such as invalidation of the study’s findings or legal consequences.

Identifying and Resolving Participants’ Concerns

Participants’ recruitment and retention are two major bottlenecks that significantly increase clinical trial delays. They are crucial for the clinical trial’s scientific validity as well as for financial considerations. Therefore, problems with recruiting and retaining participants should be addressed and reduced. During recruitment via ICFs, it is important to appropriately address concerns, including participant expectations, situational vulnerability, and understanding the objective of participation.

Moreover, participants with less education require more explanation time and in-depth conversations to satisfy their concerns regarding the information in the consent process. Hence, the investigator must be more empathetic and diligent with the participants while interpreting the information. They should also anticipate several questions from the participants’ end and address each of their questions positively and in detail to ensure their safety as well as privacy. The quality and quantity of communication between the investigator and the participant matter for a participant to make an informed decision.10

Inclusivity in Informed Consent Forms—What’s the Idea Behind it?

The ICFs should be inclusive of all gender-neutral language, as many transgender individuals have said they were discouraged from participating. Because they were addressed with improper pronouns or because the investigators didn’t know how to refer to gender-affirming operations accurately. The major rationale for utilizing gender-neutral language is to establish a welcome gesture for people of all gender identities and sexual orientations.11

Payoff

Therefore, based on the above discussion, it is evident that language and communication play an important role in participants’ informed decision-making. Also, a well-written, succinct, and gender-neutral ICF ensures early recruitment and retention. By providing the study participants with easy-to-understand, lay-friendly instructions. Moreover, these forms ensure the standard ethical considerations and legal norms set by the regulatory bodies are complied with by the researchers. Therefore, an ICF is the fundamental building block for conducting an ethical and accountable clinical trial.

References

  1. US Food and Drug administration. Informed consent for clinical trials. fda.gov. Published April 01, 2023. Accessed July 20, 2023. 
  2. American Cancer Society. What is informed consent? cancer.org. Published May 13, 2019. Accessed July 20, 2023. 
  3. Code of federal regulations. Subpart B—Informed Consent of Human Subjects. Updated July 24, 2023. Accessed July 25, 2023. 
  4. Shah P, Thornton I, Turrin D, Hipskind JE. Informed Consent. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 11, 2022. 
  5. Gupta UC. Informed consent in clinical research: Revisiting few concepts and areas. Perspect Clin Res. 2013;4(1):26-32. doi:10.4103/2229-3485.106373 
  6. US Department of Health and Human Services. 2018 Requirements (2018 Common Rule). hhs.gov. Accessed July 21, 2023. 
  7. Niyibizi NK, Speight CD, Najarro G, et al. Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information. BMC Med Ethics. 2022;23(1):34. Published 2022 Mar 27. doi:10.1186/s12910-021-00736-x. 
  8. US Food and Drug administration. A guide to informed consent. Published October 06, 2019. Accessed July 21, 2023. 
  9. Pick A, Gilbert K, McCaul J. The role of effective communication in achieving informed consent for clinical trials. Nurs Stand. 2014;29(10):45-48. doi:10.7748/ns.29.10.45.e9443 
  10. Chaudhari N, Ravi R, Gogtay NJ, Thatte UM. Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspect Clin Res. 2020;11(2):64-69. doi:10.4103/picr.PICR_206_19. 
  11. UCI office of research. Using inclusive, gender-neutral language in the IRB consent templates. news.research.uci.edu. Published June 15, 2023. Accessed July 24, 2023. 

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