
Written by Elissa Capelle Vaughn,
What’s the origin story of a life-changing consumer medical product or surgical advancement?
The road toward a medical breakthrough isn’t possible without human research and clinical trials. Studies are where the big ideas are born and tested. Research brings invested parties together across industries, from doctors to legal teams, to gather valuable insights for product development and medical procedures.
Clinical trials are more than a necessary step. They’re a powerful signal of trust to patients and over-the-counter consumers. As Google puts it, the topic of health falls under “your money, your life.” The stakes are high from every angle, whether you’re leading or sponsoring a study, making compliance essential at every level of a research study.
Learn more about the accountable parties behind human research compliance.
Who Leads the Study?
Behind every clinical research study is a large team of industry professionals with wide-ranging expertise. These teams develop and manage the human research end, or human subject research (HSR), of the clinical trial.
Every team member has a duty to uphold all compliance measures relating to this type of work. The job of compliance doesn’t rest with just one person; however, some individuals have more compliance-related duties.
For example, the principal investigator (PI) is the head researcher who leads the human research study and works with study participants. They’re the “face” of the study for clinical trial participants and must exemplify the highest standards of clinical trial compliance.
It’s not uncommon for PIs to delegate study workloads to lower-level investigators or research coordinators, especially if the study is large. However, despite delegation, the lead PI is still the primary party responsible for ethical breaches. For example, if a PI delegates a portion of the study to another researcher, and that researcher violates compliance regulations, the PI is also held responsible for noncompliance.
It’s important to understand that human research PIs interact directly with voluntary trial participants. Compliance ensures the integrity of the study and data.
Participant Safety Oversight
Since the PI leads the human research study, they’re in charge of overseeing patient safety. Therefore, this role requires frequent communication with doctors and relevant external parties, like clinical trials lawyers who ensure medical product testing is legal and compliant with industry and state regulations.
The study’s principal investigator is expected to immediately report any serious adverse events (SAEs) and unexpected adverse events (AEs) to both the study sponsor and the Institutional Review Board. IRBs also work directly with clinical trial lawyers.
PIs are responsible when a study participant is injured. Therefore, they must develop an injury care protocol before launching the study, ensuring that medical care is quickly administered.
ALCOA Compliance
FDA approval is crucial in medical product development, whether you’re developing a new prescription drug or a bandage. PIs must strictly follow the ALCOA data documentation framework to ensure a smooth path to FDA approval. ALCOA stands for:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
Research study data must be attributed to the lead researcher who produced (and modified) the report.
Data must be legible, which means it must be presented in a clear manner.
All study data must be recorded at the very time it was generated, ensuring that reports are contemporaneous.
Reports must be original; PIs are required to show the original copy of the data report.
Lastly, PIs must ensure that all reported research data is accurate and reliable. Research reports should also be free of errors before submitting to an approval body. All case report forms (CRFs) must align with any medical records or lab results from the study.
HIPAA and Policy Compliance
Human research studies are subject to both health and research-based laws. The Health Insurance Portability and Accountability Act (HIPAA) is widely recognized, also by patients and study participants. HIPAA protects clinical study participants from the unauthorized release of patient health information (PHI).
The Family Educational Rights and Privacy Act, or FERPA, may receive less attention in conversations about research, but it’s just as important. This act protects student records, which include academic performance and behavioral data.
Research studies cannot deviate from clinical trial agreements (CTAs), which also include compensation and injury coverage for study participants. Informed consent forms (ICFs) for study participants must align with the CTA.
It’s the responsibility of human research PIs to enforce these data privacy protocols.
Who Sponsors Human Research Studies?
This question will lead you to a range of corporate and academic entities, from major pharma companies to research institutions. While PIs are the “face” of the study for participants, sponsors are the “face” of the study itself.
Sponsors both initiate and finance medical research studies. Broadly, they’re accountable for a clinical study’s global impact, which could encompass multiple countries.
Study Quality Monitoring
Sponsors are responsible for selecting and monitoring a study PI’s overall performance. PIs legally commit to this role via Form FDA 1572, which is the official Statement of the Investigator.
PIs work with clinical trial participants directly. Study sponsors, on the other hand, are responsible for the quality of the study at large.
Study sponsors must form teams of experts to build and oversee quality assurance (QA) and quality control processes. Sponsors are expected to audit research labs and data to ensure all quality measures are followed.
If an audit reveals a compliance breach at a research site, the sponsor is expected to take immediate corrective action, which can include termination of the site.
Safety Reporting Duties of Sponsors
While PIs must report to IRBs, sponsors must also submit safety reports to government agencies. They must evaluate study data from all research sites to determine if trial products resulted in injuries. Life-threatening injuries must be reported to government regulatory agencies within 15 days.
What Are Contract Research Organizations?
Also known as CROs, contract research organizations are outsourced parties that work on clinical trials. Studies of this scope require a lot of work across various fields, prompting sponsors to outsource certain roles.
A sponsor may outsource all clinical trial management to a CRO. Once the Transfer of Regulatory Obligations (TORO) is complete, the CRO will select the PIs, oversee resource allocation, and so forth. CROs are accountable for specific duties outlined in their contract, which may also include data management, research site monitoring, or safety reporting.
Even with a TORO in place, study sponsors still retain primary legal liability for the medical product being studied. CROs are responsible for the operations they manage.
What Is the Role of an Institutional Review Board?
Conflicts of interest can tarnish the integrity and contaminate the data of a research study. Clinical trials require independent oversight solutions like institutional review boards (IRBs) to hold appropriate parties accountable.
The IRB for a study protects the rights and well-being of human research subjects. Clinical studies must be reviewed for acceptable risk-benefit before they can proceed. IRBs also review informed consent forms for clarity before they’re distributed to study participants.
The Data Safety Monitoring Board
While the IRB assesses the accountability of sponsors, CROs, and PIs, the data safety monitoring board (DSMB) monitors data for compliance.
For example, if a study’s data reveals an unexpected level of harm, this would be cause to cease a study. On the other hand, if the DSMB discovers benefits well above expectations, the DSMB would recommend ceasing the placebo control group so that these participants could benefit as well.
Hospital Compliance
Studies that are conducted within the hospital system are also reviewed by healthcare compliance teams. These teams focus on the hospital’s institutional risk and legal obligations.
Research billing is typically handled by hospital compliance teams. To avoid large fines under the False Claims Act, clinical trial drugs must be billed to the study, not Medicare. These teams also manage conflicts of interest that could arise between healthcare institutions (or pharmaceutical companies) and researchers.
Compliance Training and Education
You can’t have proper accountability without competency. Updated and ongoing compliance training is absolutely crucial to research integrity. To ensure all research staff are prepared, sponsors, CROs, and hospitals should mandate certified compliance training.
For example, training from the Collaborative Institutional Training Initiative, or CITI, is industry-standard for medical research professionals. A CRO may require that all study researchers have CITI training.
Human Subjects Protection (HSP) training is available through the Office for Human Research Protections under the U.S. Department of Health and Human Services. Good Clinical Practice (GCP) training, along with HSP, is also offered through the CITI program.
Research institutions and healthcare organizations can also foster a culture of compliance by promoting continuing education (CE) beyond industry-standard training. Including interactive compliance material in the research staff onboarding, like presentations and quizzes, can promote critical compliance principles from day one.
Conduct Compliance-First Research Studies
Designing a human research study with compliance in mind provides an extra layer of protection for all parties. Use this guide to develop a knowledge base of roles, responsibilities, accountable entities, and legal guidelines. Promote a culture of compliance to inspire medical breakthroughs built on ethics and good data.
Author Bio: Elissa Capelle Vaughn is a New York-based content writer who covers trending topics in health and wellness. She also brings a diverse background in sales and marketing to her work when discussing communication strategies in the health field.
Please also review AIHCP’s Health Care Management Certification program and see if it meets your academic and professional goals. These programs are online and independent study and open to qualified professionals seeking a four year certification


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