Experts Share Ways to Streamline Informed Consent Process in Clinical Trial Startup

At a busy research site, a clinical trial is ready to launch — but it’s stuck in limbo over a single paragraph in the informed consent form (ICF). The issue? Language relating to the potential cost of participation. One site’s language on what they will pay for differs from another’s, and the contradictory wording needs to be reviewed and agreed to by the sponsor before the IRB can proceed. While the trial waits for approval, patients who are eager for a new treatment face delay.

This scenario, shared during a recent Advarra webinar, captures one of the frustrating bottlenecks that arise when institution-specific requirements hold up the single Institutional Review Board (sIRB) review process. Minor differences in language — whether related to costs, state laws or institutional policies — can derail timelines, slowing the path to innovative therapies.

Advarra convened a panel of experts to discuss practical solutions for balancing compliance with efficiency in clinical trial startups. Regulatory attorney and director of IRBMed for University of Michigan Kindra Cooper, Advarra institutional research director Josh Fedewa, and Advarra global review services leader James Riddle offered insights into how stakeholders can streamline the ICF process without compromising participant protection.

Why Institutional Requirements Matter

Institutional differences are not arbitrary. Many requirements address legitimate concerns like compliance with state laws or unique operational contexts. For instance, in Nebraska, a person must be 19 before they are legally considered an adult with full rights and responsibilities, such as signing contracts or consenting to participation in research without a guardian. In most other states, the age is 18, so tailoring consent language for where trials are located is critical.

Age isn’t the only factor to consider. In California, HIPAA forms must be printed in size 14 font. Meanwhile, Illinois has specific requirements relating to the Genetic Information Privacy Act (GIPA), which mandates unique consent language to address how genetic data will be stored and used. This is where the informed consent process helps to translate these requirements into meaningful, localized information for participants.

“From an institutional perspective, we view the informed consent — even in these multi-site trials — as the best way of delivering local context-specific information to participants that may not apply to subjects at other sites,” Cooper said.

However, not all modifications are rooted in legal or regulatory necessity. Some reflect institutional preferences that add complexity without providing additional protection to participants, according to Fedewa.

“Sometimes, institutional preferences or policies masquerade as needs,” Fedewa said. He pointed to examples like requiring financial office contact details in consent forms — details that could just as easily be communicated in an ancillary document. “These additions can complicate reviews and delay approvals unnecessarily.”

Key Challenges in the Current Process

The ICF process can often become a maze of negotiations, with three primary hurdles:

• Multiple Handoffs: Each sponsor, CRO, site and IRB reviews and modifies the document, leading to delays. These reviews, edits and changes can go back and forth multiple times, even after the central IRB has completed its review.
• Conflicting Language: Disputes often arise over state-specific requirements, like Illinois’s genetic information law, which different sites interpret differently.

“We’ve seen sites in the same state use slightly varied language, creating confusion for sponsors and IRBs,” Fedewa said.

• Resource Constraints: Many institutions lack dedicated legal counsel for research, forcing study teams to juggle legal and operational reviews. This adds days—or even weeks—to the process.

Real-World Concerns: Key Questions from the Field

During the webinar’s Q&A session, participants shared additional examples of common pain points.

As highlighted at the beginning of this article, one participant described how misaligned cost language repeatedly delayed their trials. In this case, each research site required slightly different wording to reflect its financial policies, causing time-consuming back-and-forth reviews. To resolve the issue, panelists suggested moving these details to a separate addendum, rather than embedding them in the main consent form, could streamline the process without sacrificing transparency.

Another raised the issue of readability. Public teaching hospitals often prioritize plain language in consent forms to ensure accessibility for diverse patient populations. While the FDA requires these forms to be written in a language understandable to participants, there’s room for interpretation in how this standard is applied, according to Cooper.

“There are no black-and-white rules about reading levels in the regulations,” Cooper said. “It’s left to the IRB to determine what’s appropriate for the participant population.”

Solutions and Best Practices

To address these challenges, the panelists highlighted several practical solutions aimed at improving efficiency in the informed consent process:

• Negotiate Early

Pre-negotiating institution-specific language during the Clinical Trial Agreement (CTA) phase can help avoid conflicts during the IRB review process. Aligning on language early ensures smoother approvals and minimizes delays.

• Pre-Vetting Templates

Institutions that proactively align with sponsors on standardized consent language see significant reductions in review cycles and back-and-forth negotiations. Pre-approved templates streamline the process by addressing common issues upfront.

• Use Ancillary Documents

Site-specific details—such as parking information or financial office contacts — can be communicated through separate participant-facing materials rather than embedded in the main consent form. This approach keeps ICFs streamlined and easier to review.

• Dedicated Resources

Hiring dedicated legal counsel for research operations ensures expertise is available to manage reviews efficiently and consistently. This investment can significantly reduce bottlenecks and improve turnaround times.

Looking Ahead

The industry is already making strides toward addressing these inefficiencies. Institutions are adopting centralized systems to manage ICF language, and sponsors are increasingly open to pre-negotiation during CTAs.

The panel also stressed the importance of collaboration. By working together earlier in the process, sponsors, CROs and sites can resolve potential conflicts before they become delays.

“It’s about recognizing that every stakeholder shares the same goal: getting therapies to patients faster,” Cooper concluded.

Streamlining the informed consent process is a critical step in reducing clinical trial delays. By addressing real-world challenges—like misaligned cost language and readability concerns—stakeholders can make significant strides in improving study startup times.

The key lies in balancing compliance with efficiency. Through early negotiation, pre-vetted templates, and thoughtful use of ancillary documents, the industry can overcome the hurdles that have long plagued the informed consent process. In doing so, institutions and sponsors can deliver therapies to patients faster — without compromising the quality or integrity of the research.

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