| The
University of North Dakota recognizes the importance
of your decision to participate in a research
study. Your participation in the study is voluntary,
and you may choose not to participate or you
may discontinue your participation at any time.
Your decision whether or not to participate
will not affect your current or future relations
with the University of North Dakota.
Questions?
• The investigator conducting the study provides
contact information for specific questions
about the study procedures. You may contact
the investigator with questions at anytime
during or after the study.
• If you can’t reach the investigator or wish
to discuss the study with someone other than
the investigator, you may contact the Institutional
Review Board at 701-777-4279.
• If you have questions regarding your rights
as a research subject, or if you’d like to
discuss problems or concerns; obtain information;
or offer input with an informed individual
who is unaffiliated with the research project,
you may contact the Institutional Review Board
at 701-777-4279. All calls will remain confidential,
and if you prefer, anonymous.
Information About Becoming a Research
Participant
“Becoming a Research Volunteer: It’s Your Decision.”
Brochure created by the Office of Human Research
Protections, U.S. Department of Health and Human
Services.
http://www.hhs.gov/ohrp/outreach/documents/3panelfinal.pdf
“Clinical Trials Information”. Office of Research
Administration, School of Medicine and Health
Sciences, University of North Dakota.
http://www.med.und.nodak.edu/researchadmin/clinicaltrials.html
“Questions to Ask Before Participating in a
Research Study”. Office of Human Research Protections,
U.S. Department of Health and Human Services.
http://www.hhs.gov/ohrp/outreach/questions.html
“Taking Part in Research Studies: What Questions
Should You Ask?” Centers for Disease Control
and Prevention, U.S. Department of Health and
Human Services.
http://www.cdc.gov/hiv/resources/brochures/unC3bro.htm
Ethics Principles for Research
“The Nuremburg Code” Office of Human Research
Protections, U.S. Department of Health and Human
Services.
http://www.hhs.gov/ohrp/references/nurcode.htm
“Declaration of Helsinki: Ethical Principles
for Medical Research Involving Human Subjects”.
The World Medical Association.
http://www.wma.net/e/policy/b3.htm
“The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects
of Research”. Office of Human Research Protections,
U.S. Department of Health and Human Services.
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
Federal Regulations Governing Human Subjects
Research
Department of Health and Human Services (DHHS)
45 CFR 46 ("The Common Rule" - Human
Subject Protections)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Food and Drug Administration (FDA)
21 CFR 50 (Protection of Human Subjects)
http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr50_02.html
21 CFR 56 (Institutional Review Boards)
http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr56_02.html
21 CFR 312 (Investigational New Drugs)
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr312_01.html
21 CFR 812 (Investigational Device Exemptions)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812
Comparison of FDA and HHS Human Subject Protection
Regulations (by FDA)
http://www.fda.gov/oc/gcp/comparison.html
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