To assure that, in research involving human subjects, the rights and welfare of the subjects are protected, and to provide our clients with excellent and professional service while complying with relevant federal regulations.
MidLands IRB is in compliance with requirements of FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46, and International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), as applicable.
Statement of Signature Requirement
Demonstrating a constant focus on delivering the highest quality performance possible, effective 01 September 2015, MLIRB will no longer apply signatures to approval documents and other routine communications provided to clients and to investigator sites. This decision was made based on review of current regulatory requirements, industry standards and a continued client focus. This process change is strengthened by our commitment to provide you with the quality of service you deserve.
MLIRB complies with regulations of the United States Food and Drug Administration as described in 21 CFR Parts 11, 50 and 56, the International Conference on Harmonization (ICH) E6, the Common Rule including the United States Department of Health and Human Services 45 CFR Part 46, and applicable local laws.
MidLands IRB Registration with OHRP and FDA
On January 15, 2009, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) issued final rules requiring registration of Institutional Review Boards (IRBs). The rules are effective July 14, 2009.
In accordance with 21 CFR 56.106 and 45 CFR 46.106, MidLands IRB is registered with the FDA and the Office for Human Research Protections (OHRP). The parent registration # is IORG0001486 which represents the overall registration of MidLands IRB.
Each IRB receives a distinct identification number under the parent registration number. The registration number for MidLands Board #1 is IRB00001931 and the registration number for Board #2 is IRB00007629. The MidLands IRB registration currently expires on 18 April 2017. The registration may be verified through OHRP’s web site at http://ohrp.cit.nih.gov/search/search.aspx.
WHAT OUR CLIENTS ARE SAYING
“The responsiveness and professionalism of MLIRB is truly impressive. I will always remember when MLIRB arranged a Saturday quorum on 2 days’ notice in order for our company to meet a dosing milestone for a sponsor. Their IRB Chairperson is always available to provide our Regulatory group with guidance and suggestions.”
Bradley D. Vince, D.O.
President and Medical Director
Vince and Associates Clinical Research
“The MidLand's Independent Review Board is the most professional and efficient non-academic IRB with which I have had the opportunity to work. Consisting of two boards who each meet weekly, they provide prompt review and approval of acceptable research protocols; possess devoted and committed, highly knowledgeable members who are above reproach with regard to conflict of interest; and consistently work to ensure full disclosure to subjects and subject protection from unnecessary risk. MidLands is our 'go to' IRB and I recommend them enthusiastically and without qualification.”
Sandra K. Willsie, D.O., MA, FACP, FCCP
Medical Director, Early Development Services
PRA Health Sciences
"It is always a pleasure to work with MLIRB. Their knowledge base allows for thorough and easy completion of necessary regulatory documentation prior to submission. Once submitted, MLIRB review, feedback and eventual decision is always within agreed window. Whenever contacting MLIRB, their staff is always friendly, professional and easily accessible."
Casey Johnson, D.O.
President, Principal Investigator
Johnson County Clin-Trials
"In my 16 years of working at a research site, MidLands IRB has been, in my professional experience, the best IRB to work with. Their boards are thorough and do a great job of protecting the subjects. The staff is efficient, friendly and helpful. For example, MidLands frequently works with us to meet very aggressive timelines. Additionally, their website is easy to use and access. I would recommend MidLands for any site or sponsor looking to explore a new IRB."
Regulatory Specialist, Early Development Services
PRA Health Sciences