- Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect July 19, 2018.
- The changes to the Common Rule do not apply to FDA-regulated studies.
- ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source of information and updates about the revised Common Rule roll out.
- Studies submitted on or after July 19, 2018 will be reviewed under the revised Common Rule. Currently approved studies will continue to fall under the pre-2018 Common Rule requirements.
- The revisions to the Common Rule go into effect July 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date.
- New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 07.19.18.
- Revised SOPs will be posted on the UMCIRB website.
- Existing expedited studies approved prior to January 19, 2018 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with ORIC, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.
- Keep our website and the ePIRATE homepage checked for continuing and updated information.
- Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
- Remember, the revised Common Rule does not apply to FDA-regulated studies.
Supplemental Education for Investigators, Coordinators & Other Study Team Members
OHRP offers an assortment of educational videos developed by the Division of Education and Development. These videos provide information on a variety of topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human participants of research described at 45 CFR part 46. Each video is approximately 20-25 minutes in length. Click on the following link: HHS YouTube channel to view the selection of educational videos. A sample of video titles available includes:
- Biobanking: When Issues with Tissues Come a Knockin’
- When PIs Come a Knockin’: Everything Investigators Want to Know but are Afraid to Ask
- OHRP: Research Use of Human Biological Specimens and Other Private Information
- OHPR: Reviewing and Reporting Unanticipated Problems and Adverse Events
- OHRP Research Involving Vulnerable Populations
- OHRP: General informed Consent Requirements
The Research Clinic
The Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) present The Research Clinic. The interactive training video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct. The Research Clinic allows the viewer to assume the role of one of four characters and determines the outcome of the storyline by selecting decision-making choices for each “playable” character. Click on the following link to view “The Research Clinic”