June 2025: RAC Digest

Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

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Welcome to the RAC Digest!

RAC stands for “Research Administration and Compliance”.

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

• These 10 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:

IMPORTANT NOTICE:

Please note the following articles listed below, the blog author was granted permission to summarize key points ONLY. It will be notated if interested folks can contact the authors for a copy of the article or if the article can’t be shared for other purposes (other than for discussing general key points in this post):

1. Privacy, Policy, and Profits: Survey of Patient Preferences for Research on De-Identified Biosamples – please email Dr. Marielle S. Gross, MD, MBE if you would like to review the article
2. The Black Prisoners of Stateville: Race, Research, and Reckoning at the Dawn of Precision Medicine – individuals without institutional access to this article may contact the authors for a copy (contact information located within the article)
3. Content and Readability of Informed Consent Documents Approved by Research Ethics Committees of Health Institutions in South-East Nigeria – this article can’t be shared for other purposes

Let’s get started:

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Bridging ethics and culture: a co-created, culturally sensitive informed consent framework for research in Bimoba and Mamprusi communities in Ghana

• While Western informed consent (IC) models emphasize individual autonomy, IC models in many Global South communities (e.g., Ghana) focus on collectivist cultural norms
• Findings of the study led to the development of an IC and participant recruitment framework, including the following four steps:
  • Community entry
  • Independent mediation at households
  • Invitation of eligible participants
  • Multi-step recruitment approach
• The study illustrates how individual autonomy can be effectively used in sociocultural contexts where decision-making is relational (i.e., in communities)

Comfort of Sexual and Behavioral Health Survey Research Participation among Undergraduate Students: Findings from a Random Sample of a Southern University

• The majority of undergraduate students surveyed reported feeling somewhat or very comfortable answering online survey questions related to sensitive topics such as:
  • Alcohol use,
  • Drug use, and
  • Mental health
• Though fewer students reported comfort with questions about sexual behaviors, researchers found that students who used alcohol before or during sex were over six times more likely to be comfortable answering sexual behavior questions
  • There were no other major demographic factors influencing comfort levels on these topics
• Based on these findings, research of this nature can meet the CFR’s minimal risk standard and may be evaluated as exempt, rather than expedited, IRB review
  • However, this should be evaluated on a case-by-case basis (given the researcher’s study sample was somewhat small and homogenous)

Empowering Research Teams: A
Guide to Effective Post-Award
Management Training for Principal
Investigators and Research Staff

• This article how to develop an effective post-award management training for principal investigators and research staff
• Post-award training should encompass:
  • Teaching research teams why something is important and necessary
  • Opportunities for hands-on skill building related to post-award management
  • How-to documents, written guidelines, forms, and contact information to assist the research team
• Lastly, the training content and needs should be tailored towards your institution

Privacy, Policy, and Profits: Survey of Patient Preferences for Research on De-Identified Biosamples

• The study aims to identify patient preferences to inform ethical frameworks, policies, and technologies for advancing biobanking and precision medicine
• A significant portion of participants preferred receiving research results that could impact their health
  • This especially held true if these research results impacted their family’s health
  • Research results were desired even if it meant being re-identified
• Over half of the participants stated they would prefer maximizing working with for-profit companies to speed the development of new cancer treatments
• Participants expressed strong preference in being informed if their donated tissues are in high demand
  • They also stressed that they should have a say in how their samples are used, especially when researchers are in competition for their samples

Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration–National Institutes of Health Collaboration

• The FDA and NIH formed an initiative to define clinical research terms related to innovative study designs, with a focus on studies using real-world data (RWD)
  • This working group was initiated in April 2023
• This paper describes how the Modernizing Research and Evidence (MoRE) glossary was developed
  • You can review the glossary itself here: MODERNIZING RESEARCH AND EVIDENCE (MoRE) CONSENSUS DEFINITIONS: AN FDA-NIH COLLABORATION

Developing, implementing, and transferring a faculty-led RCR training program

• Virginia Tech’s division of Scholarly Integrity and Research Compliance (SIRC) developed an “Investigator Series” to fulfill the RCR training requirement
  • This series invites investigators to examine the ethical dimensions of their research and lead conversations about how they address these issues in their daily work
  • This proactive approach provides real-life dilemmas and solutions (in lieu of being a check-the-box compliance activity for an institution’s RCR program)
• RCR coordinator identify faculty who might be interested in presenting for the series and provide consultations to explain the goal of these presentations: provide insights into the decisions that were made to facilitate ethical research
• The RCR coordinator also serves as the presentation moderator to provide introductory key points about ethical research
  • Further, they ensure that discussion and questions about the presentation remain framed around the central topic of conducting ethical research

Bots, scammers, and fraudulent responders: a year of disrupted data collection

• The study highlights how bots, scammers, and fraudulent responses can compromise the integrity of research leading to harmful/ineffective policies and/or interventions
• Common fraud prevention methods (e.g., CAPTCHA, trick questions, IP tracking, and attention checks) are increasingly ineffective against evolving bots that incorporate AI
• The article further describes the ethical trade-offs with online research
  • One example mentioned was the verification of participant identities via social media (as participants may feel that researchers have violated their confidentiality by searching for them online or violated of trust)
• Though a manual process, the paper suggests the following in evaluating the truthfulness of survey responses, e.g.,
  • Using the standard methods mentioned above along with reviewing for consistency/duplication of survey responses, grammar issues in survey responses, and the time to complete the survey

Disclosing generative AI use for writing assistance should be voluntary

• This paper indicates that mandatory disclosure policies are unnecessary, can lead to tensions, and are overall counterproductive
• As an example, the authors state how the assistance of AI for spelling and copy editing doesn’t meet the requirements for formal recognition as the tool didn’t assist with content generation
• It is also the authors’ concern that investigators will include a blanket statement that the investigator used AI to assist with writing, but not specifically being transparent of how AI was used to assist with writing

The Black Prisoners of Stateville: Race, Research, and Reckoning at the Dawn of Precision Medicine

• This paper discussed that Black prisoners were integral to the Stateville studies, providing the crucial data about adverse drug reactions (as opposed to the viewpoint that only White prisoners were of interest)
• Stateville researchers localized primaquine (antimalarial) sensitivity to a genetic disorder resulting in reduced activity of the enzyme glucose-6-phosphate dehydrogenase (G6PD)
  • Decreased enzyme activity renders individuals unable to combat the oxidative stress triggered by exposure to antimalarial drugs
• The researchers not only studied the Black prisoners, but also recruited their family members to study the inheritance pattern in a coercive manner
• Lastly, the article stresses the lack of accessibility of G6PD testing in certain communities
  • The World Health Organization (WHO) recommends G6PD testing to protect those who are G6PD deficient as part of antimalarial campaigns; however, financial barriers and other challenges inhibit this

Content and Readability of Informed Consent Documents Approved by Research Ethics Committees of Health Institutions in South-East Nigeria

• This study assessed the content and readability of the 241 informed consent documents (ICDs) approved for biomedical research in South-East Nigeria from 2019 to 2021
• A vast majority of the ICDs lacked the basic elements of informed consent (as outlined in the Common Rule)
  • Further, the readability for ICDs were below recommended standards
• The paper recommends that institutions train researchers and ethics committee members on how to write clear and concise ICDs that are easy to read and understand

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I hope you found this content useful!