US Based or Funded Research
US Based or Funded Research
|Department||Applied Educational Research|
|Creation Date||June 2, 2014|
|Approval Date||June 2, 2014|
|Effective Date||June 2, 2011|
This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.
The purpose of this policy is to describe specific regulatory accountability for research that is based in the United States and/or is funded by a U.S. funding agency.
The REB is committed to promoting participant protection and ethical conduct for all research endeavours carried out at The Michener Institute. Investigators are required to comply with current scientific, regulatory and ethical standards for the protection of human research participants and the Michener Research Code of Conduct. All research involving human participants must meet certain criteria before REB approval is granted. Research projects that are based in the United States and/or are funded by a U.S. funding agency MAY require additional compliance with U.S. regulations.
This policy applies to the Chair, Investigators, members of the Research Office and/or administration, and REB.
2.1 United States Regulations
2.1.1 Research that is conducted or supported by the United States Department of Health and Human Services (HHS) or any other U.S. government agency and/or falls under the Food and Drug Administrations (FDA) purview must comply with the following requirements in addition to those requirements mandated for research in Canada (see References):
- Research conducted or supported by HHS:
45 CFR 46-Federal Policy for the Protection of Human Subjects (contains 5 parts of which subpart A “The Common Rule” is based) the baseline standard of ethics by which any government-funded research in the US is held-nearly all academic institutions hold their researchers to these statements of rights regardless of funding)
- Research that falls under the purview of the FDA (drugs, biological products, and medical devices):
21 CFR 50-Protection of Human Subjects http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html; and,
21 CFR 56-Institutional Review Boards http://www.gpo.gov/nara/cfr/waisidx_02/21cfr56_02.html.
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996.
- World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011. (DRAFT)
- Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)
- US Department of Health and Human Services (HHS) Code of Federal Regulations (CFR), Title 45 Part 46. http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html
- US Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Title 21 Parts 50 & 56. http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html & http://www.gpo.gov/nara/cfr/waisidx_02/21cfr56_02.html