Policies & Regulations
2018 Revised Common Rule
The 2018 Revised Common Rule went into effect on January 21, 2019. Since that date, all new research that is subject to HHS oversight is reviewed under the 2018 SOPs listed below unless the research is FDA-regulated. The Revised Common Rule Overview and Guidance provides details about the regulatory changes.
Standard Operating Procedures (SOPs) for the 2018 Revised Common Rule
- 2018 requirements SOP 01.0: Institutional Review Board (IRB) Authority and Institutional Commitment 04/2020
- 2018 requirements SOP 02.0: Initial Review Procedures 04/2020
- 2018 requirements SOP 03.0: IRB Relation to Other KUMC Committees 09/2020
- 2018 requirements SOP 04.0: Privacy and Confidentiality 09/2020
- 2018 requirements SOP 05.0: Reviews of Ongoing Research 06/2020
- 2018 requirements SOP 06.0: Continuing Review Procedures 06/2020
- 2018 requirements SOP 07.0: Informed Consent Requirements 06/2020
- 2018 requirements SOP 08.0: Selection and Recruitment of Subjects 06/2020
- 2018 requirements SOP 09.0: Vulnerable Populations 04/2020
- 2018 requirements SOP 10.0: Research with Human Biologic Material 12/2019
- 2018 requirements SOP 11.0: FDA-Regulated Research 06/2020
- 2018 requirements SOP 12.0: Social and Behavioral Research 06/2020
- 2018 requirements SOP 13.0: Collaborative Research 06/2020
- 2018 requirements SOP 14.0: Reliance on External IRBs 06/2020
- 2018 requirements SOP 15.0: Education and Training in Human Research Protections 06/2020
- 2018 requirements SOP 16.0: IRB Office Procedures 06/2020 (Kansas City campus)
- 2018 requirements SOP 17.0: Institutional Responsibilities 06/2020
- 2018 requirements SOP 18.0: Investigator Responsibilities 06/2020
- SOP 20.0: Flexible IRB Review 06/2020
Standard Operating Procedures (SOPs) for studies approved under pre-2018 Common Rule
The four SOPs listed below apply to any FDA-regulated studies and to any study approved by the IRB prior to January 2019 when the new common rule came into effect. Any "2018 requirement" SOPs not listed below apply to all studies approved by the IRB.
- pre-2018 requirements SOP 02.0: Initial Review Process 04/2020
- pre-2018 requirements SOP 06.0: Continuing Review Process 06/2020
- pre-2018 requirements SOP 07.0: Informed Consent Requirements 04/2020
- pre-2018 requirements SOP 10.0: Research with Human Biologic Material 12/2019
KUMC Policies Related to Research
- KUMC HRPP Policy on PI Proxy
- KUMC HRPP Policy on Genome-Wide Association Studies
- KUMC Research Institute Policies
- KUMC Research Records Retention
Links to Federal Policies and Regulations
- Office for Human Research Protections (OHRP)
- US Food and Drug Administration (FDA)
- Genomic Data Sharing (GDS / NIH)