IRB Standards And Guidelines
UAF researchers are expected to maintain high professional standards as appropriate for their discipline. Researchers must also comply with Federal regulations and, for projects receiving external funding, sponsor requirements; these requirements should serve as minimum professional standards. It is the responsibility of principal investigators and student advisers to lead by example and to mentor trainees and staff in all aspects of research ethics and the responsible conduct of research.
Working with indigenous populations or disadvantaged groups requires additional care and preparation to ensure that activities are conducted in a culturally appropriate manner. Since much of the work of UAF researchers is conducted with Alaska Native communities, we have tried to provide links to information issued by Native organizations and to groups that have a history of working with Native communities.
- Office for Human Research Protections (OHRP), U.S. Department of Health and Human
Services is the primary regulatory agency affecting UAF research involving human participants.
This site has a wealth of information and guidance for the investigator as well as
- 45 CFR 46 Protection of Human Subjects - This is the actual regulatory code that that defines the roles and responsibilities of institutions, IRBs and principal investigators.
- Indian Health Service, US Department of Health and Human Services
- Model Tribal Research Code (PDF) (copyright by American Indian Law Center, Inc. 1999) has sample consent forms and documents providing guidance for research involving Alaska Natives and American Indians.
- Guidance on Extension of an FWA to Cover Collaborating Individual Investigators. Issued by the Office of Human Research Protections (OHRP). Individual Investigator Agreements extend an institutions Federalwide Assurance to cover an unaffiliated collaborator. A sample form is available on the Forms page.
- Guidance on the use of another institution's IRB. Issued by the Office of Human Research Protections (OHRP). IRB Authorization Agreements allow one FWA institution to rely on another FWA institution's IRB for review and oversight. A sample form is available on the Forms page.
U.S. Department of Education: Protection of Human Subjects in Research (this site provides links to pertinent guidance and regulations addressing research in an education setting - includes a link to 34 CFR part 99 FERPA)
‘Walk softly and listen carefully’: Building research relationships with tribal communities. The National Congress of American Indians Policy Research Center and Montana State University's Center for Native Health Partnerships published this policy paper in 2012 called, "Walk Softly and Listen Carefully: Building Research Relationships with Tribal Communities". It was produced with insights from those involved with tribal research in Montana and elsewhere.
Principles for the Conduct of Research in the Arctic. Prepared by the Interagency Social Science Task Force in response to a recommendation by the Polar Research Board of the National Academy of Sciences and at the direction of the Interagency Arctic Research Policy Committee. They are not intended to replace other existing Federal, State, or professional guidelines, but rather to emphasize their relevance for the whole scientific community. Examples of similar guidelines used by professional organizations and agencies in the United States and in other countries are listed in the publications.
Guidelines for Improved Cooperation Between Arctic Researchers and Northern Communities: This is a draft (8/23/2004) document created by the NSF Office of Polar Programs Arctic Sciences Section and Barrow Arctic Science Consortium with input from the Alaska Eskimo Whaling Commission, the Barrow Whaling Captains Association, the Alaska North Slope Borough Department of Wildlife Management, and the Alaska Native Science Commission.
Alaska Federation of Natives Research Guidelines (available on the Alaska Native Knowledge Network Website)
Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects (revised Oct. 2008). This document was originally adopted by the World Medical Association in June 1964.
The Belmont Report released in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, provides the ethical framework for the Federal Regulations designed to protect human research subjects.
Most of these links direct you to white papers, standards of professional conduct, or the code of ethic for a specified organization.
American Sociological Association (Code of Ethics)
Public Responsibility in Medicine & Research (PRIM&R) is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research.
Code of Research Ethics as adapted by the Alaska Native Science Commission from
the Kahnawake Schools Diabetes Prevention Project Copyright 459302 (January 22, 1997) available on the Alaska Native Science Commission website
Declaration on the Rights of Indigenous Peoples (A/RES/61/295). Adopted by the United Nations General Assembly, 9/3/07.
The Council on Government Relations (COGR) has drafted two excellent summary documents describing the changes to the federal regulations on human subject research. UAF researchers will see these changes reflected on the IRB website, the IRBNet submission system, and in protocol documents and templates. To read COGR's summaries.
The 2019 International Compilation of Human Research Standards edition has been released and is now available online. The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 131 countries and standards issued by several international and regional organizations. To learn more...
The Federal Policy for the Protection of Human Subjects (the Common Rule) has undergone substantial revisions. These changes will affect multiple aspects of the IRB review process. The IRB and the Office of Research Integrity are revising the affected IRB forms and templates, which will be posted on the IRB website and in the IRBNet protocol submission system on the Common Rule implementation date of January 21, 2019. You can read more about these changes here.
NIH's Office of Human Research Protections (OHRP) has made available country-based guides for the new European Union General Data Protection Regulations (GDPR). These new regulations apply to all data collected from individuals within the European Union (EU) and the European Economic Area (EEA). They apply to human research projects if data is collected from individuals in the EU and EEA. To read more about the GDPR in general.