302 Informed Consent Process
| Document Name: Informed Consent Process | Document Number: 302 | Revision Date: 30JUL2024 | Supersedes: 403.00 |
| Target Group: Research Personnel | Approval Date: 20Dec2024 | Effective Date: 01Jan2025 | Training Required: -Human Subjects Protection (HSP) -Good Clinical Practices (GCP) |
Purpose
To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.
This Standard Operating Procedure (SOP) describes procedures for performing informed consent and storage of records by the CTRU staff to be in compliance with Ohio University, state, and federal policies and regulations.
Responsibilities
The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.
Procedures
1. General Requirements
- All researchers at Ohio University must obtain informed consent from human participants before their involvement in research. This is a matter of professional ethics across all disciplines.
2. Obtaining Informed Consent
- The PI or their delegate must ensure participants have ample opportunity to consider participation and that the process minimizes coercion.
- The consent document is part of an ongoing communication process, detailing the study's purpose, procedures, risks, benefits, participant rights, and alternatives. It should not be viewed solely as a legal record.
3. Witnessing Consent
- The consent can be witnessed by a designated study team member. If consent is obtained remotely, the study coordinator can document the discussion.
4. Addressing Understanding and Reconsenting
- If there are concerns about participant understanding, reconsent should be obtained at the next appointment, following a renewed discussion.
5. Documentation and Storage
- A signed copy of the IRB-approved consent must be provided to the participant and retained in the research file. Consent forms should be stored securely, accessible to authorized personnel, and separate from participant-coded data.
6. Oral Consent:
- If participants have limited literacy or language comprehension, oral consent may be obtained with a short form. This process requires a witness and IRB approval of both the oral presentation and short form.
7. Assent for Minors
- Assent forms must be used for minors who can understand a simplified consent version. For younger children, oral explanations must be provided. Both parental consent and child assent are required.
8. Informed Consent Document Contents
- Must be written in plain language, including the following elements:
- PI's name, project title, and identification as research.
- Purpose and objectives of the research, participant inclusion criteria.
- Procedures, including experimental aspects, duration, and participant activities.
- Risks, discomforts, and any alternative procedures.
- Benefits to participants and society.
- Privacy protection and data confidentiality measures.
- Treatment and compensation in case of injury.
- Contacts for questions about the study and participant rights.
- A statement on voluntary participation and the right to withdraw without penalty.
9. Special Participant Considerations
- Specific consent processes are required for vulnerable populations, including children, prisoners, mentally disabled individuals, pregnant women, and others as identified by federal regulations such as the Belmont Report.
10. Compliance and Storage
- Consent forms are legal documents and must be stored securely and separately from other data. They must be accessible for university or federal audits and retained according to regulatory requirements.
Applicable Regulations, Guidance, and Policies
| Regulation | Title |
|---|---|
| 21 CFR 50 | Protection of Human Subjects |
| 45 CFR 46 | Protection of Human Subjects |
| ICH E6(R2) | Guideline for Good Clinical Practice E6 Integrated Addendum |
| Belmont Report | Belmont Report |
| FDA Guidance for Industry | Adverse Event Reporting to IRBs- Improving Human Subject Protection |
References: None
Attachments: None
Appendices: None
Approver: Director, CTRU and Clinical Partnerships