Offering Lottery Entry as an Incentive for Research Participation Compromises Informed Consent
Simon Paul Jenkins
Ethics & Human Research, May-June 2023; 45(3) pp 18-28
Abstract
This paper argues that offering entry into a lottery as an incentive to those who participate in research studies represents a challenge to the principle of informed, coercion-free consent that is considered an essential ingredient of permissible recruitment to studies. This is, first, because information about the chances of winning in this context is normally unavailable to potential participants and, without this, they cannot accurately weigh up the risks and potential benefits of participation. Second, even when this information is available, such an incentive capitalizes, I contend, on the difficulty of weighing up small probabilities, exploiting the fact that people tend to be beset by cognitive biases that make it challenging to make decisions rationally. The resulting conclusion is that we should not view lotteries as more ethical than simply paying participants, when the latter is feasible.

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials
Research Article
Nahathai Dukaew, Mingkwan Na Takuathung, Wannachai Sakuludomkan, Kanyarat Chairaksa, Preeyaporn Klinjan, Nimit Morakote, Nut Koonrungsesomboon
Clinical Trials, 16 May 2023
Abstract
Background/Aims
An informed consent form is essential in drug development clinical trials. This study aimed to evaluate regulatory compliance and readability of informed consent forms currently being used in industry-sponsored drug development clinical trials.
Methods
This descriptive, cross-sectional study evaluated the informed consent forms of industry-sponsored drug development clinical trials conducted at the Faculty of Medicine, Chiang Mai University, between 2019 and 2020. The informed consent form’s compliance with the three major ethical guidelines and regulations (i.e. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6(R2) Good Clinical Practice; Declaration of Helsinki; and the revised Common Rule) were analyzed. The document length and the readability scores (using Flesch Reading Ease and Flesch-Kincaid Reading Grade) were assessed.
Results
Of 64 reviewed informed consent forms, the average page length was 22.0 ± 7.4 pages. More than half of their length was mainly devoted to three elements: trial procedures (22.9%), risks and discomforts (19.1%), and confidentiality and the limit of confidentiality (10.1%). Although most of the required elements of the informed consent form content were included in most informed consent forms, we identified four elements with often missing information in the form: aspects of research that are experimental (n = 43, 67.2%), involvement of whole-genome sequencing (n = 35, 54.7%), commercial profit sharing (n = 31, 48.4%), and posttrial provisions (n = 28, 43.8%).
Conclusion
The informed consent forms in industry-sponsored drug development clinical trials were long but incomplete. Our findings draw attention to ongoing challenges in industry-sponsored drug development clinical trials, where deficient informed consent form quality continues to exist.

Readability of Consent Forms: Sponsor Templates versus Locally Approved Consent Forms
Dissertation
Joyce D. Brown
Rush University ProQuest Dissertations Publishing, 2023
Abstract
Background
Respect for person is a basic ethical principle of the Belmont Report and includes the need to treat research participants as autonomous individuals during the consenting process. Federal guidance has recommended consents be written at a 6th to 8th grade reading level. However, it is not clear that these reading recommendations actually occur in reality. The overall goal of this project explores whether the results of sponsor provided, and Institutional Review Board (IRB) approved consents at a local site achieve the desired reading levels.
Methods
This quality improvement project identified research studies in the Pulmonary and Critical Care Division of Rush University Medical Center from 2014-2023, where a sponsor consent and a Rush IRB consent were both available. Readability software calculated consent comparison scores. Data resulted from use of the Flesch Reading Ease (FRE), Flesch- Kincaid Grade Level (FKRL), and Simple Measure of Gobbledygook Index (SMOG) scores.
Results
After reviewing the research study records, 18 studies met inclusion criteria for the project and consents selected for the medical intensive care unit recruitment (39%) and (61%) for outpatient pulmonary disorders research. The eighth-grade level for each metric was 60 for FRE, 8 for FKGL and 8 for the Smog Index score. Using a t-test, the mean readability metrics for the sponsor consents was greater than the 8th grade (FRE: 53.75 (SE=1.56), t-test = -3.98; p = < 0.001; FKGL: 9.74 (SE=0.29), t-test = 5.83; p = < 0.000; Smog Index: 12.15 (SE=0.23), t-test = 17.62; p = < 0.000). Similarly, the mean readability metrics for Rush IRB consents was greater X than the 8th grade (FRE: 53.51(SE=0.90), t-test = -7.17; p = < 0.000; FKRL: 9.90 (SE=0.17), ttest =  10.61; p = < 0.000; Smog Index: 12.20 (SE=0.14), t-test = -29.13; p = < 0.000). Paired ttest results conducted on the sponsor and IRB consents show no difference on any of the readability metric and therefore show no statistically significant difference (sponsor vs. Rush IRB for FRE 53.75 vs. 53.51, t-test = -2.32, p = 0.81); for FKGL 9.74 vs 9.90; t-test = 0.83, p = 0.41, and for SMOG 12.15 vs 12.20, t-test = .33, p = 0.73.
Discussion
Readability scored both the sponsor and IRB consent templates above the 8th grade reading level. Additional research is warranted to advance the properties of readability in the sponsor and IRB templates.

A Narrative Review of the Rationale for Conducting Neonatal Emergency Studies with a Waived or Deferred Consent Approach
Review Articles
Anup Katheria, Georg M. Schmölzer, Annie Janvier, Vishal Kapadia, Ola D. Saugstad, Maximo Vento, Alla Kushnir, Mark Tracy, Wade Rich, Ju Lee Oei
Neonatology, 9 May 2023
Abstract
Emergency research studies are high-stakes studies that are usually performed on the sickest patients, where many patients or guardians have no opportunity to provide full informed consent prior to participation. Many emergency studies self-select healthier patients who can be informed ahead of time about the study process. Unfortunately, results from such participants may not be informative for the future care of sicker patients. This inevitably creates waste and perpetuates uninformed care and continued harm to future patients. The waiver or deferred consent process is an alternative model that may be used to enroll sick patients who are unable to give prospective consent to participate in a study. However, this process generates vastly different stakeholder views which have the potential to create irreversible impediments to research and knowledge. In studies involving newborn infants, consent must be sought from a parent or guardian, and this adds another layer of complexity to already fraught situations if the infant is very sick. In this manuscript, we discuss reasons why consent waiver or deferred consent processes are vital for some types of neonatal research, especially those occurring at and around the time of birth. We provide a framework for conducting neonatal emergency research under consent waiver that will ensure the patient’s best interests without compromising ethical, beneficial, and informative knowledge acquisition to improve the future care of sick newborn infants.