Tag: publication

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Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators! 260+ blog subscribers and counting!

Welcome to the RAC Digest!

RAC stands for “Research Administration and Compliance”.

The RAC Digest will feature select publications from the previous month.

• These 12 articles will come from journals related to research administration and research compliance.

As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

If your institution does not have access to the publications listed below and you would like access, please fill out the form below:

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What’s in a Lie? How Researchers Judge the Justifiability of Deception

• Researchers assess deception based on factors such as:
  • The nature of the deceptive act,
  • How believable the deception is,
  • Participant suspicions, and
  • The emotional or behavioral outcomes for participants.
• Ethical judgments are influenced by:
  • Relationships (e.g., adult/child),
  • The power dynamics involved, and
  • The norms of participant populations.
• Deceptive methods are often justified when non-deceptive methods can’t obtain “true” participant behavior and/or data.
  • However, participant harm must be minimized.
• Deception may reduce consent validity if it prevents participants from forming accurate beliefs about the study.
  • Truth-like or vague deception methods are recommended to preserve partial understanding of the study.
• More coherent, context-specific frameworks are needed to better guide ethical evaluations of studies involving deception.

Incorporating Gender-Neutral Language in IRB Materials: Perceptions of IRB Professionals

• The study surveyed 642 IRB professionals and found substantial support for incorporating gender-neutral language in IRB guidance and consent documents.
• Though this concept is highly supported, there are a few obstacles that hinder application. A couple of examples include:
  • Lack of resources and awareness
  • Perception that changes are not required by federal regulations
• Most respondents agreed that gender-neutral language is appropriate in IRB guidance, templates, and consent forms regardless of AAHRPP accreditation status.
  • However, respondents whose IRBs were not accredited showed stronger agreement than respondents whose IRBs were accredited.
• Most respondents indicated that the FDA and OHRP should provide guidance for IRBs and investigators regarding the use of gender-neutral language in IRB materials.

Undue Inducement and Disparate Impact: A Collectivist Account

• Bobier challenges the conception of undue inducement.
  • An offer is considered “undue” if it impairs the individual’s ability to make rational or voluntary decisions.
• He proposes a collectivist alternative, arguing that inducements are undue when they result in the disproportionate enrollment of protected classes.
  • This theory draws on the legal concept of disparate impact. I.e., shifting the ethical concern from individual autonomy to collective justice and equity.
• Finally, he states that this method of thought can be easily operationalized by IRBs.
  • Inducements are undue when they result in an unjustified disparate enrollment pattern:
    • A protected class of individuals is overly enrolled,
    • that protected class is not integrally tied to the study objectives, and
    • There are alternative recruitment methods available that would not result in this enrollment pattern.

Equitable Data Sharing in Collaborative Health Research in Sub-Saharan Africa: A Translational Bioethics Perspective

• Data sharing tends to be unequal.
  • Researchers in the Global South often act as data collectors.
  • Researchers in the Global North tend to control data analysis and publications.
• Several ethical, legal, and practical barriers hinder data sharing in Sub-Saharan Africa such as:
  • Lack mandatory frameworks for electronic data sharing
  • Inconsistent approval processes across countries which create delays destroy trust among researchers
  • Inadequate infrastructure (e.g., persistent power outages)
• The authors advocate for a translational bioethics framework that bridges ethical theory and practical application. Some key components include:
  • Embedding reciprocity into data-sharing policies
  • Establishment of clear data management plans, which define rules for data access, use, and storage while safeguarding privacy and security
  • Accountability mechanisms should include mandatory reporting structures.
    • Here researchers would be required to document how shared data is being used, by whom, and why.

Society of Family Planning Research Practice Support: Researcher and institutional review board considerations for sexual and reproductive health research with minor adolescents

• The article emphasizes that the inclusion of adolescents is essential for developing effective, age-appropriate interventions and policies.
• An interesting point to mention is that if state laws permit minors to consent to specific medical services (e.g., contraception), they can also independently consent to participate in research related to the service.
• Researchers and IRBs are encouraged to design studies that minimize risks and respect adolescents’ autonomy.
  • Relatedly, the authors offer guidance on how IRBs can interpret regulations to support ethical inclusion, e.g., when waivers of parental consent are appropriate.

Informed Consent in Vulnerable Populations: The Case of Detained Persons with Attention Deficit Hyperactivity Disorder

• The study found no significant difference in informed consent comprehension between detained individuals with ADHD and those without ADHD.
• Individuals with ADHD and without ADHD demonstrated similar willingness to sign the informed consent forms and participate in research.
• Unfortunately, the overall understanding of the informed consent content was low in both participant groups.
  • This highlights a broader issue in conveying complex consent form content effectively to detained individuals.
  • Further research could investigate the effectiveness of alternative informed consent formats in improving the understanding of informed consent such as:
    • Interactive consent tools,
    • Audio-visual aids and
    • Comprehension checks

Optimizing Informed Consent—A Call to Action

• This viewpoint delves into the necessity to increase efforts to implement a truly participant-centered informed consent process.
• The authors express that informed consent should be considered as much an area of innovation as other aspects of clinical trial design and delivery.
• They intend to identify additional ways to improve how the research community designs and obtains informed consent, in partnership with:
  • Potential research participants,
  • Researchers, and
  • Others in the clinical trial and clinical practice communities

Research Participant Interest in Learning Results of Biomarker Tests for Alzheimer Disease

• Out of 274 cognitively unimpaired participants, 40% declined to learn their Alzheimer’s disease (AD) biomarker results.
  • Black participants were nearly twice as likely to decline receiving their biomarker results.
  • Further, participants with a known parental history of AD dementia were more likely to decline learning their biomarker results.
• Qualitative interviews revealed that declining the results was that knowing the results would be a burden. Examples of this perceived burden include:
  • Create or exacerbate memory concerns of the participant
  • Knowing these results may create negative emotions for the participant
  • May impact how the participant leads their life from that point forward

A Clinical Research Interaction Scale for Racial and Ethnic Minority Participants

• The study aimed to examine how the quality of interactions between clinical research staff and participants from racial and ethnic minority groups affects their trust in the research process and their willingness to engage in future clinical trials.
• The study found that negative experiences were associated with a decreased willingness among participants to enroll in future studies.
  • This suggests that improving the quality of interactions between research staff and participants from minority groups can enhance trust and potentially increase participation rates in clinical trials.
• It is recommended to implement training programs for research staff to guide culturally sensitive interactions and foster trust.

Digital Sentience? Evaluating the Integration of AI-Driven Tools in Animal Welfare Assessment

• AI tools enable real-time monitoring of physiological and behavioral indicators to detect stress, disease, and other welfare concerns.
  • They also help reduce animal use in research through predictive toxicology.
• A huge barrier to this is the requirement for large, high-quality, labeled datasets to train AI algorithms effectively.
• Many AI tools lack generalizability across species, environments, and behaviors.
  • Studies often use data from specific animal groups without testing adaptability for other various conditions.

Advancing Research Administration with AI: A Case Study from Emory University

• Emory University’s Office of Research Administration (ORA), in collaboration with the Goizueta Business School, developed a proof-of-concept generative AI chatbot named ORAgpt.
  • This tool aims to provide research administrators with instant, accurate information on ORA processes and policies.
  • Further, the tool would streamline administrative tasks and supporting research operations.

Inviting Participation: From Sample-Building to Relationship-Building in Participant Recruitment Processes

• The study challenges the conventional view of participant recruitment as a transactional, outcome-driven process.
  • The author advocates for a relationship-building approach, emphasizing sustainable, respectful participant–researcher interactions.
• Here, the invitational rhetoric framework is explored in how it can build sustainable participant–researcher relationships.
  • Using this framework as an analytical lens, the study evaluated how study advertisements on university Study Discovery Sites (SDSs) foster conditions of:
    • Value,
    • Safety, and
    • Freedom.
• Several recommendations were provided to researchers including designing recruitment materials that avoid oppressive language (e.g., stating “participant” in lieu of “subject”).

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I hope you found this content useful!