SPONSOR/CRO



SPONSOR/CRO

IRB Services is a service-driven organization with a core focus on participant protection in human research. We are committed to providing efficient customer-oriented services to research sponsors while providing the highest standard of human subject protection. We partner with Sponsors, CROs, and Researchers to promote and deliver scientifically and ethically sound human research. We act to cultivate a culture of conscience within our organization our partners.


When working with IRB Services you can simply expect more:

  • Multiple Boards with frequent meetings

  • Rapid reporting of Board decisions

  • Online submissions for sponsors and sites using SmartForms Technology and CIRBI™

  • Streamlined applications focused on essential information

  • Experienced and service oriented support staff

  • Dedicated experts for unique needs of various study phases:

    • Phase I & Special Projects

    • Phase II - IV Studies

    • Continuing Reviews

    • Translation Services

Community Based Research

Community based research comprises a range of activities in health, education, social and behavioral science as well as other disciplines designed to systematically gather important information about various aspects of the human condition. Most of these research projects employ qualitative research methodologies, or a mix of quantitative and qualitative methodologies, and often include special circumstances. Community based research functions work best by engaging and collaborating with communities and their citizens beginning with defining the research need through collaboration to completion of the research and communication of the results to the various stakeholders. Many times, such research projects are international in scope.

IRB Services has broad experience in reviewing community based research conducted in virtually every region of the globe, as diverse as the patient needs assessments, health determinants and outcomes in various communities and strata of society. These may include studies of substance abuse, domestic violence, problem gambling, human factors, and educational intervention innovation, to name a few. These projects are often publicly funded, or funded by the communities themselves with limited governmental or NCO support.

If you would like to know more about the services we offer to support community based research, including information about fees, please contact us for more information.

Phase I BA/BE (Bioavailability/Bioequivalence) Research

IRB Services understands the unique demands and requirements of fast paced Phase I BA/BE research and its nuances in both Canada and the United States. We have many years of experience in this area and work with many of North America’s largest and most successful clinics. Experienced and dedicated teams of IRB Services staff and IRB Reviewers facilitate rapid turnarounds while maintaining the highest quality in research participant protection, reliability, and service. Please contact us for information about our Phase I BA/BE Study review services.

Minimal Risk Research: Expedited Review

Research that poses no more than “minimal risk” to participants among other considerations may be eligible to be reviewed via an “Expedited Review”. “Expedited Review” means that the research is reviewed by the Chair, or one or more designated experienced ethics board members, instead of scheduling for a full IRB review at a convened Board meeting. Please contact us for information about Expedited Reviews.

Definition of “Minimal Risk”

Broadly speaking, minimal risk research is defined as research that poses no more risk to the participant than s/he would normally experience in daily life.

USA:

The U.S. FDA and Department of Health and Human Services (DHHS) have published a document titled “Categories of Research that May Be Eligible for Expedited Review” that apply to U.S. FDA regulated, or U.S. federally-funded, research. This document states that “research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110”

URL:
http://www.hhs.gov/ohrp/policy/expedited98.html) or
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm119074.htm)


CANADA:

The Canadian Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans 2nd ed. definition of “minimal risk” is as follows (TCPS Section B):

“Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday life that relate to the research.”

NOTE: The standard requirements for informed consent (or its waiver, alteration, or exception) under relevant laws and regulations apply regardless of the type of review--expedited or Full Board--utilized by the IRB.

However, there are provisions for applicants to request a waiver, partial waiver or alteration of the consent process, which is permissible under certain conditions. When a request for alteration or waive of the consent process is received, the IRB applies strict criteria that takes relevant laws and regulations into account when determining if a waiver, partial waiver or alteration of the consent process is permissible. Please note that these criteria are not always applicable to every project, and depend on regulatory and other considerations pertinent to the research and the jurisdiction where it will be conducted.

Please contact us if you have questions about eligibility for waiver or alteration of the consent process for your research project.

Examples of Research Projects that May Qualify for Expedited Review

A few examples of research project that may qualify for expedited review include naturalistic observational studies (including certain types of post-marketing surveillance), retrospective chart reviews using anonymized data, prospective collection of biologic samples by non-invasive means (e.g., mouth swab), research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies, etc.

Note: Some of these research activities may be exempt from IRB review. Please see “Exempt Research/Exemption Determinations”

Please contact us for more information about Expedited Review of Minimal Risk Research.

IRB Exempt Research/Exemption Determinations

Certain types of research activities may be exempt from IRB review. According to US regulations, there are six categories under which the research may be exempt from IRB review. Similarly, there are specific Canadian criteria for what constitutes research, and what types of research require ethics review.

Only research involving minimal risk to participants may be accepted for determination of exemption from IRB review. Please contact us for further information about IRB Exemption Determinations.