Independent investigators play a vital role in advancing translational “bench to bedside” research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators while fostering an institution’s high-quality research and compliance.
The Hackensack Meridian Health (HMH) Research Institute’s IIRP uses a structured, integrated team approach to support independent investigators. Investigator-initiated research (IIR) is conceived by an individual, usually the principal investigator (PI), who develops a protocol for research at the site level. Examples of IIR include clinical trials with biomedical or social-behavioral interventions, data studies, surveys, quality of life studies, and epidemiological research.
Set up in 2019, the HMH IIRP program includes scientific, operational, and statistical elements, which were previously independent. “We help investigators with all steps of their project, from writing the proposal to carrying out the data analysis, supporting regulatory submissions, and disseminating results appropriately,” says Elli Gourna Paleoudis, PhD, Director, Investigator Initiated Research Program and Support Services, at HMH. “In setting up the IIRP, we took a ‘bottom-up’ approach. We were already supporting independent projects across multiple sites, and our program gradually evolved to meet this need. The IIRP is centralized, making it cost-effective, as well as being readily accessible to potential researchers.”
No specific equipment or software is needed for an IIRP. The main requirement is for a flexible team that is willing to work in different areas every day, handling protocols from across therapeutic areas. At HMH, support is offered to anyone with a promising idea for research, including attending and resident physicians, nurses, medical students, and occupational therapists. This type of approach could be tailored to any size of institution.
“By providing one-on-one support, our program adds motivation to initiate research, while reducing the investment required by the researcher,” explains Pamela Cooper, Manager, Investigator Initiated Research Program, HMH. Ways to promote the availability of an IIRP include development of a website, the inclusion of links in e-mail signatures, and a range of other resources such as master lists and an IIT library.
Starting from Scratch to Establish an Investigator-Initiated Research Program
Join Elli and Pam at ACRP 2025 [April 24-27; New Orleans, La.], where they will focus on how an IIRP, regardless of research portfolio size, will deliver scalable steps for success. View complete schedule.
“If you build it, they will come,” says Cooper, quoting from the 1989 film, Field of Dreams. Cooper suggests that institutions should be mindful of this, preparing for an influx of interest once the infrastructure is in place. At HMH, the numbers of projects underway have risen from 35 in 2015, to around 100 in 2019, and to more than 300 in 2024. Areas of support provided by the HMH IIRP include: study design and research methodology; biostatistics; regulatory; data management; basic training in topics such as Good Clinical Practice; manuscript preparation; and applying for external funding. The biostatistics team offers support in areas including protocol development, statistical analysis plans, data analysis, and preparation of abstracts and posters. The team brings expertise in clinical research, public health, behavioral research, and basic science.
“In addition to expanding our research output, we’ve had great feedback from investigators, who appreciate the centralized structure, and the fact that it is easy to identify contacts to help with their projects,” concludes Cooper.
Edited by Jill Dawson
