April 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, and Investigators! 200+ 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 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.

Let’s get started:

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Expanding Roles for Research Administration and Research Development Professionals: A Team Science Coaching Program

• Addressing Interdisciplinary Challenges:
  • Interdisciplinary research teams often face issues like:
    • Misaligned goals,
    • Leadership struggles, and
    • Communication barriers.
  • The program aims to mitigate these challenges by introducing structured team coaching.
• Training RA and RD Professionals as Coaches:
  • The initiative trained RA and RD staff to serve as team coaches, equipping them with skills to:
    • Support team formation,
    • Collaboration, and
    • The development of research outputs.
• Utilization of Team Science Tools:
  • Coaches employed tools informed by the Science of Team Science (SciTS) to facilitate effective team dynamics and project progression.
• Natural Extension of RA and RD Roles:
  • Many found the coaching role to be a seamless addition to their existing responsibilities, although interpretations varied among individuals.
• Focus on Teamwork and Taskwork:
  • Coaches addressed both interpersonal dynamics (teamwork) and project-related tasks (taskwork), ensuring comprehensive support for research teams.
• Support for Diverse and Virtual Teams:
  • The coaching model proved particularly beneficial for teams integrating diverse perspectives and collaborating virtually over extended periods.
• Implications for Research Administration:
  • The program highlights the potential for RA and RD staff to play a more active role in facilitating interdisciplinary research.
  • This suggests shift towards more integrated support structures within research institutions.

The Representative Studies Rubric: A Tool for Diversity in Clinical Trials

• The Representative Studies Rubric (RSR) was created to promote diversity in clinical trials.
  • This 12-item questionnaire that assessed whether protocols included or excluded underrepresented groups such as:
    • People of all ages,
    • Women (cis and trans),
    • Gender nonbinary individuals,
    • People who inject drugs, and
    • Pregnant people.
  • It also evaluated the use of inclusive statistical practices, community engagement, and stigmatizing language.
• Many current HIV trials still exclude underrepresented populations—often without justification.
  • The retrospective review of 47 NIH-funded HIV/AIDS trials showed frequent unjustified exclusions of:
    • Transgenders,
    • Gender nonbinary people, and
    • People who inject drugs.
• Pregnant people are frequently excluded, limiting critical safety and efficacy data.
  • This occurred without clear scientific rationale of exclusion.
• Only half of the studies included specific enrollment goals for diverse populations.
• As a result, the NIH-funded HIV/AIDS Clinical Trials Networks mandated RSR use for future protocols to proactively promote diversity.

If your institution can’t access the publication, you can download the article here: The Representative Studies Rubric: A Tool for Diversity in Clinical Trials

“Dear Editor, may I speak with you?”

• Many journals prohibit appeals and limit communication after manuscript rejection, preventing authors from understanding editorial decisions.
• Factors such as an author’s prestige, institutional affiliation, or editorial board membership can unfairly influence publication decisions.
• Restricting the number of peer-review rounds can prevent authors from fully addressing feedback and improving their work.
• There is a call for advocacy for greater editor-author communication to foster fairness and mutual understanding in the review process.
• Authors should investigate journal policies before submission, while editors should embrace transparent, responsive practices in the process.

If your institution can’t access the publication, you can download the article here: “Dear editor, may I speak with you?”

Perceptions of network-level ethics in an engineering research center: Analysis of ethical issues & practices reported by scientific & engineering participants

• There were significant variations in how authorship was assigned e.g., some labs used structured discussions.
  • A major concern from participants was unequal contributions to the research.
• Many engineers deferred ethical considerations to biomedical partners, viewing ethics as outside their domain.
• Ethics and regulatory concerns (e.g., FDA requirements) were not deeply integrated into daily research decisions.
  • Some participants feared over-regulation could suppress innovation.
• While collaboration was a central goal, early-stage efforts were often informal or idea-based.
• Participants wanted clearer, network-wide policies on data sharing, authorship, and ethics training.
• Many participants admitted limited understanding of ethics beyond lab-level compliance expressed desire for more training.

If your institution can’t access the publication, you can download the article here: Perceptions of network-level ethics in an engineering research center: Analysis of ethical issues & practices reported by scientific & engineering participants

SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials

• SPIRIT 2025 is an updated guideline for writing protocols of randomized trials.
  • The revised checklist within the guidance integrated contemporary issues like open science, patient involvement, and transparency in reporting.
• Several other items were revised for clarity and completeness such as:
  • Data sharing,
  • Conflicts of interest,
  • Blinding, and
  • Statistical methods.
• SPIRIT 2025 incorporates elements from CONSORT Harms 2022, SPIRIT-Outcomes 2022, and the TIDieR checklist.

If your institution can’t access the publication, you can download the article here: SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials

Preserving Research Ethics Oversight Amid Decimation of the Research Enterprise

• The following actions of the Trump administration has threatened the funding and functioning of IRBs:
  • Cutting grants,
  • Capping indirect costs, and
  • Reducing regulatory staff
    • All three of these components are essential for protecting research participants and maintaining public trust.
• IRBs play a vital, legally mandated role in ensuring ethical conduct in human subjects research.
  • Their effectiveness depends on institutional support and federal guidance.
• Massive cuts to OHRP and the termination of SACHRP weaken the federal government’s ability to enforce ethical standards.

If your institution can’t access the publication, you can download the article here: Preserving Research Ethics Oversight Amid Decimation of the Research Enterprise

CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials

• CONSORT 2025 introduces a 30-item checklist for reporting randomized trials. Some new changes included:
  • Reporting on data sharing,
  • Conflicts of interest, and
  • Patient/public involvement.
• Items from related CONSORT extensions (e.g., on harms, outcomes, nonpharmacological treatments) and guidelines like TIDieR were incorporated.
• Revisions to existing items emphasize transparency about protocol access and changes made after trial commencement.
• The checklist aligns more closely with SPIRIT 2025 providing consistent guidance from protocol design to trial reporting.

If your institution can’t access the publication, you can download the article here: CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials

Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use

• Only 56% of the 903 FDA-approved AI-enabled medical devices reported clinical performance studies at the time of approval, raising concerns about the depth of evaluation.
• Fewer than one-third of clinical studies included sex-specific or age-specific data, limiting assessments of device performance across diverse patient populations.
• Lastly, the study emphasized:
  • The need for continuous post-market monitoring,
  • Improved reporting standards, and
  • Stricter regulatory oversight to ensure safety, effectiveness, and generalizability of AI-enabled devices in real-world clinical settings.

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I hope you found this content useful!