Information for Research Participants

---

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/education/brochures/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

 “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://ohsr.od.nih.gov/guidelines/nuremberg.html

“Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects”. The World Medical Association.
http://www.wma.net/en/30publications/10policies/b3/index.html

“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/policy/belmont.html

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.html

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/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm

---

IRB Main Page