The reasons for deciding to form an in-house IRB or Ethics Committee (EC) are multi-faceted. Perhaps you are a non-governmental organization (NGO) or think tank who wants to make human subjects research part of your strategic mission and vision and wish to conduct IRB review internally. Maybe you are a private research site or clinical research organization (CRO) that sees in-house IRB review as a vital component of an evolving compliance program. Or, maybe you are international organization desiring to compete in the international clinical research market and need to form an IRB or EC for site selection purposes.
Whatever your reasons for forming an IRB or EC, building a research review operation from the ground up is not a simple task.
Before ever conducting an IRB meeting, an organization must go through important capacity building exercises to ensure that the research review operations are structurally and administratively sound and that the IRB or EC is appropriately qualified through its knowledge and experience to ensure that subjects are adequately protected. A failure to address either the administrative or substantive aspects of IRB or EC review leaves both human subjects and organizations vulnerable to increased risk.
And so, if you are building an in-house IRB or EC from the ground-up, it is critical to have a knowledgeable advisor guide you through the process of carefully considering issues such as:
- How to identify qualified IRB members and chairs.
- How to train and educate IRB members on their ethical and regulatory responsibilities.
- How to select the individual or department who will be responsible for administering the IRB or EC.
- How to develop standard operating procedures to guide the operations and determinations of the IRB or EC.
- How to determine the number of staff members needed to administer the IRB or EC.
- How IRB or EC related data will be stored and managed.
- Whether office space is needed for the IRB or EC.
- Whether an electronic system will need to be purchased or built to support the IRB or EC’s operations.
- How investigators will submit research to the IRB or EC.
- Whether the IRB or EC will need to develop submission forms for investigators.
- Whether the IRB or EC will need reviewer tools and checklists to aid them in their review.
- How investigators will be trained and educated on their IRB or EC-related responsibilities.
Though the challenge of building an IRB or EC may seem daunting, HRP can leverage its over 50 years of combined experience in human subject protection to make the process of developing a research review operation as seamless and straightforward as possible. For more information about our IRB and Ethics Committee Start-Up services, please contact us at (347) 862-9321 or by email at services@thehrpconsultinggroup.com.