Human Research Protections (IRB)
Important Notice Regarding COVID-19 and IRB Research
The Human Research Participant Protection Program provides assistance to investigators in fulfilling their obligation to plan and conduct research involving human participants in accordance with the highest scientific and ethical principles. The Institutional Review Board (IRB) provides research oversight and evaluation of the institution's research involving human participants by ensuring compliance with the ethical principles embodied in The Belmont Report and the College of Charleston policies and procedures.
- Frequently Asked Questions [English] [en Español]
- Final Revisions to the Common Rule effective July 19, 2018
- Flexibility Policy for non federally funded research
- Qualtrics Survey Software is available for use by faculty, staff and students at no cost.
- Required Training (CITI Program)
COVID-19 Resources
- COVID-19 and IRB Research Guidance (pdf)
- IRB COVID Safety Notification for Research Participants (pdf)
- Safety Notification- Editable Version (rtf file)
- Safety Notification- Online Shortcuts (pdf with QR code and bit.ly link)
- COVID Checklist (fillable pdf)- only required for active in-person research involving more than minimal risk
- College of Charleston Back on the Bricks webpage
Guidance Topics
- Anonymity
- Anonymous Surveys
- Deception in Research
- Ethnography
- Public Data Sets (no irb application required)
- Research using Social Networking Sites New
- Student Records and FERPA
- Students as Research Participants
- Students as Researchers
- Teacher Action Research/Exemption Category 1
- Using Pre-Existing Data
Standard Operating Procedures
- Data Security
- Dietary Supplement Research
- EU General Data Protection Regulation
- Human Performance Laboratory
- Human Research Review Procedures
- Recruitment of Participants by Non-College of Charleston Researchers
- Reliance (Inter-Institutional) Agreements
Forms
Note: Use the NEW eForm application system for all new applications to the IRB beginning 2/8/2021. Any applications currently under review can remain in the Legacy Application system. Modifications and final reports of previously-approved protocols must be submitted in the Legacy Application system, unless PI has initiated a transfer to new eForm system. Contact compliance@cofc.edu for assistance or to request a transfer of your protocol to the new eForm system.
- NEW eForm Application System (requires CofC credentials)
- Instructions for Researchers
- Instructions for Faculty Sponsors (Note: Faculty sponsors now required to submit to the IRB on behalf of the student researcher)
- Video Instructions coming soon!
- Legacy Human Research Review Application and Addendum (requires CofC credentials)
- Instructions
- Note: no longer accepting new applications in Legacy system. Addendum submissions for existing protocols are still accepted.
- Legacy protocols can be moved to new eForm system by PI request. Please contact compliance@cofc.edu.
- Participant Compensation Form
- External Request to Recruit Research Participants (Non-College of Charleston researchers only)
Templates
- Anonymous Survey Consent
- Adult Consent - Letter/Narrative Style
- Adult Consent - Outline Style
- Adult Consent- Education Research (Exemption Category 1)
- Child Assent - Elementary School
- Child Assent - Middle School
- Parental Permission
- Parental Permission - Exemption Category 1
- Photo/Video/Audio Release
IRB Meetings and Membership
- Meeting Schedule and Application Deadlines - Deadlines are only relevant for applications requiring Full Board Review. Expedited and Exempt (Administrative) Reviews are conducted on a rolling basis.
- Membership Roster
- IRB Members Website (restricted access)
College of Charleston Policies and Procedures
- Policy on the Protection of Human Research Participants
- Financial Conflict of Interest Disclosure
- External Requests to Recruit Research Participants
Resources
- Office of Human Research Protections (OHRP)
- OHRP Frequently Asked Questions
- U.S. Federal Regulations - Protection of Human Subjects (45 CFR 46)
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- The Belmont Report
- Declaration of Helsinki
- Ethnography and IRBs
- Oral History Association Principles and Best Practices
- Federal Drug Administration (FDA) Science and Research
- International Compilation of Human Research Standards
- Listing of Social-Behavioral Research Standards from around the world (HHS)
- About Research Participation (HHS Public Outreach Website)
Federalwide Assurance (FWA) for the Protection of Human Subjects: #00000772
For further information contact
Compliance@cofc.eduResearch Protections and Compliance
Office of Research and Grants Administration
Office location: 407-G BellSouth Building