IRB: Additional Resources

Students must register their research and complete their CITI training before starting their research.

Accomplishments should be submitted to: Scholarly Activities/Research Publications

• De-Identification Guide 
• Elements of Informed Consent

• General Consent Template
• Verbal Consent Template
• Online Survey Consent Template
• Information Sheet
• Case Report Informed Consent Form
• FERPA Consent to Release Student Information for Research Form
• Data Use Agreement Template 
• IRB Protocol Template

• ACOM Student Research Policy
• ACOM Student Research Procedure
• FERPA Compliance Policy
• FERPA Rights Policy
• Research Misconduct Policy
• Handling Allegations of Research Misconduct Procedure
• Responsible Conduct of Research Policy
• Principal Investigator Policy

• HIPAA Authorization Required Elements 
• Request Southeast Health EPIC Access
• Data Management Procedure & Data Requests

Decision Charts (For Research Determinations)

• Does your research involving secondary data require IRB review? 
  • Secondary Data 
• FERPA and the use of educational data
  • FERPA Compliance
• Does your research require IRB review?
  • IRB Review

Human Subject Regulations Decision Charts: 2018 Requirements [Content created by Office for Human Research Protections (OHRP)]

• Chart 01: Is an Activity Human Subjects Research Covered by 45 CFR Part 46?
• Chart 02: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.104(d)?
• Chart 03: Does Exemption 45 CFR 46.104(d)(1) for Educational Practices Apply?
• Chart 04: Does Exemption 45 CFR 46.104(d)(2) for Educational Tests, Surveys, Interviews, or Observation of Public Behavior Apply?
• Chart 05: Does Exemption 45 CFR 46.104(d)(3) for Benign Behavioral Interventions Apply?
• Chart 06: Does Exemption 45 CFR 46.104(d)(4) for Secondary Research that Does Not Require Consent Apply?
• Chart 07: Does Exemption 45 CFR 46.104(d)(5) for Public Benefit or Service Programs Apply?
• Chart 08: Does Exemption 45 CFR 46.104(d)(6) for Food Taste and Acceptance Studies Apply?
• Chart 09: Does Exemption 45 CFR 46.104(d)(7), Storage for Secondary Research for Which Broad Consent Is Required, Apply?
• Chart 10: Does Exemption 45 CFR 46.104(d)(8) for Secondary Research for Which Broad Consent Is Required Apply?
• Chart 11: Is Continuing Review Required Under 45 CFR 46.109(f)?
• Chart 12: Waiver or Alteration of Informed Consent in Research Involving Public Benefit and Service Programs Conducted by or Subject to the Approval of State or Local Government Officials (45 CFR 46.116(e))
• Chart 13: When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f)?
• Chart 14: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?

The Family Education Rights and Privacy Act (FERPA) is a federal law that safeguards the privacy of student education records. These records are considered confidential and may not be disclosed to third parties without the student’s written consent. Any educational institution receiving funding from programs administered by the U.S. Department of Education is required to comply with FERPA.

FERPA defines education records as any records—regardless of format—that contain information directly related to a student and are maintained by an educational institution or a party acting on its behalf. Examples of education records include:

• Graded assignments or papers
• Exams
• Transcripts
• Class rosters
• Computer systems containing student information

To access student education records for research purposes, the Principal Investigator (PI) must obtain the student’s written, signed consent. This requirement may apply even in cases where human subjects research regulations do not mandate a signature. In such instances, FERPA’s more stringent requirements take precedence. The Institutional Review Board (IRB) does not have the authority to waive this requirement.

Researcher Responsibilities When Handling FERPA-Protected Data

Approval to use student education records in research is conditional upon the researcher’s agreement to the following:

• Use the data solely for the purposes outlined in the approved research project. Any new or different use requires separate approval.
• Implement appropriate safeguards to protect the data from compromise or unauthorized access. A detailed data security plan should be included in the research protocol.
• Limit access to education records to only those research team members with a legitimate research-related need.
• Prevent individuals outside the research team from accessing any personally identifiable information.
• Share data only in aggregate form, ensuring that it is properly de-identified to prevent the inadvertent disclosure of student identities.