Chapter 5

Regulations Affecting Clinical Research, Including HIPAA: The Regulatory Framework Within Which WCG IRB Functions

WCG IRB Compliance Statement:

WCG IRB is duly constituted and has written procedures in compliance with requirements defined in 21 CFR Parts 50 and 56, 312, 812, 45 CFR 46 and ICH Guidelines relating to Good Clinical Practice. WCG IRB’s mission is to ensure that research is conducted ethically according to the principles of the Belmont Report and in compliance with all federal and international (ICH) regulations, state laws and that the rights and welfare of human participants are protected.  

WCG IRB is registered with FDA/OHRP. 

WCG IRB registration number is IRB00000533 (IRB00002354 for our Canadian panel), and WCG IRB’s parent organization number is IORG0000432.

WCG IRB reviews many types of human participant research, including clinical research, behavioral research, and epidemiological research, in the United States and Canada. WCG IRB reviews research in accordance with three primary standards, as well as other regulatory standards, when appropriate:

  • The Food and Drug Administration (FDA) Regulations on research with human beings (21 CFR 50 and 56), and 
  • The Health and Human Services (HHS) Regulations on research with human beings (45 CFR 46 Subparts A, B, C, and D),
  • The International Conference on Harmonization (ICH) “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry.”

The FDA regulations apply to clinical investigations conducted on medical products under FDA jurisdiction that will be marketed in the United States; principally drugs, devices and biologics.

The HHS regulations apply to research that is funded by HHS and other agencies that have adopted “the Common Rule,” represented at 45 CFR 46, Subpart A. Institutions that receive federal funding for research must obtain an “assurance,” a formal agreement with the government in which the institution promises to take prescribed steps for the protection of human participants. Usually, the type of assurance will be a Federal-wide Assurance (FWA) from the Office for Human Research Protections (OHRP). However, for some research, other types of assurances may be used or necessary. If you have questions about obtaining an assurance, see the section of this investigator handbook entitled “Special Considerations for Federally Funded Research,” consult the OHRP web site, or contact WCG IRB Client Care at 855-818-2289 or 1-617-243-3924 or clientcare@wcgclinical.com.

WCG IRB can help researchers and institutions comply with the NIH Single IRB policy – contact us for more information.

The International Conference on Harmonization (ICH) is an international standard for drug approval that has been adopted as either law or guidance in many countries (EU, Canada, Japan and the United States). In the United States, FDA has adopted it as guidance. ICH is similar to the FDA drug and IRB regulations, but has a few stricter standards.

WCG IRB has established written procedures that ensure that research approved by WCG IRB meets these three primary standards. However, WCG IRB may vary from the requirements of one of the three standards when it is not applicable. For instance, we will allow the investigator to vary from the ICH requirement that the participant receive a signed consent form for an HHS-regulated behavioral interview study conducted in a setting where a signed copy of the consent form represents an unacceptable risk of breach of confidentiality for the participant.

In addition, WCG IRB reviews research funded by the Department of Defense, the Department of Education, and other federal agencies. 

Research Conducted Globally

For research conducted outside North America, WCG IRB is happy to provide U.S. review in conjunction with a local IRB when required for funding or regulatory reasons. Other cases can be considered on an individual basis.

We do not provide IRB review of research in other countries where there is not a local IRB. This includes research for which it is unclear if local regulations require IRB review, such as stem cell research, device research, tissue collection studies, and questionnaires and surveys. 

HIPAA

WCG IRB also provides services under the Privacy Rule (45 CFR Parts 160 and 164of the Health Insurance Portability and Accountability Act of 1996). WCG IRB will review requests for waivers of authorization and partial waivers of authorization for covered entities upon request (requests for review of partial and full waivers of authorization can be made through ClinSphere® eReview Manager or IRBNet). WCG IRB will also review authorization language upon the request of a covered entity. If the authorization language is embedded in the research consent document, then the IRB must review it. If the authorization language is separate from the research consent document, then the covered entity may determine whether or not to submit the language for IRB review. WCG IRB will review separate authorization documents upon request.