Veritas IRB - hrppd

By: Veritas Irb  09-12-2011
Keywords: Human Research Protection Programs

Since drug research and development necessarily involves risk, this risk must be managed through careful planning, which necessitates the development of a Human Research Protection Program (HRPP). Development of an HRPP implies that the persons responsible for the conduct of a clinical trial:

  • adopt principles and standards toward the protection of research participants;
  • develop a structure by which employees, partners, and suppliers understand the set principles and standards, know their responsibilities, and are accountable for maintaining the pre-established standards;
  • develop a process by which compliance with the requirements of the HRPP is enforced and enhanced.

Veritas IRB’s regulatory and quality assurance experts can assist you, and your organization, develop an effective HRPP.

Our HRPP development services include:

  • Review and analysis of existing HRPP
  • Needs assessment of internal organizational structure and activities for HRPP development
  • Standard Operating Procedure (SOP) and policy drafting
  • HRPP compliance mechanisms development
  • On-site advice and training on HRPP development and quality assurance
  • Assistance with submissions for accreditation to the Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Keywords: Human Research Protection Programs

Other products and services from Veritas Irb


Veritas IRB - administration

If you choose to submit your study documentation by mail or courier, our administrative staff requires only one copy of at the time of submission, thus removing the administrative burden normally placed on you by other IRBs to produce multiple copies for board members. Administrative staff” refers to employees who work with the ethics board of Veritas IRB, but who are not members of the board itself.


Veritas IRB - compliance

Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects. World Health Organization Operational Guidelines for Ethics Committees that Review Biomedical Research. Division 5 of Part C of the Food and Drug Regulations of Health Canada. Mexican General Health Law, Title V, Articles 96-103. World Medical Association Declaration of Helsinki.


Veritas IRB - feasibility assessment

Our team of research professionals and consultants, as well as members of the Veritas IRB, can assist you with the development of innovative study designs and procedures by providing you with an initial ethics feasibility assessment. Feasibility assessments are very useful as they allow you to benefit from the insight of the IRB at the development stage of your study protocol. Clinical trials involving alternative medicine procedures.


Veritas IRB - services

Veritas IRB meets weekly and provides the following services as part of its standard ethical review and oversight program. Well-organized approval forms clearly identify the documentation reviewed and the decisions taken on each document. Adherence to AAHRPP-accredited procedures ensuring protection of research participant welfare and rights. On-call consultation with our knowledgeable staff on all aspects of study submission and review.


Veritas IRB - irb memberships

The Veritas IRB is a multidisciplinary group comprised of men and women with extensive knowledge of clinical research, medicine, dentistry, pharmacology, biomedical sciences, genomics, alternative medicine/natural health, ethics, law, and social sciences.


Veritas IRB - overview

Established in 1996, Veritas IRB is an experienced and transparent Independent Review Board committed to ensuring the safety and rights of research participants, the unbiased supervision of studies, and the conduct of research according to the highest standards of ethical and clinical practice. Veritas IRB is the only Canadian-based IRB to be fully-accredited by the Association for the Accreditation of Human Research Protection Programs.