207 CTRU Biorepository
| Document Name: CTRU Biorepository | Document Number: 207 | Revision Date: 12JUL2024 | Supersedes: None |
| Target Group: Research and lab Personnel | Approval Date: 20Dec2024 | Effective Date: 01Jan2025 | Training Required: -Bloodborne Pathogens Training |
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 the procedures for storing research samples in the CTRU Biorepository.
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. Guardian:
- A guardian must be appointed for each repository stored in the CTRU Biorepository; the Guardian will be a CTRU staff member. The Guardian is responsible for:
- Ensure biospecimens are stored appropriately to preserve the viability of the biospecimen.
- Ensuring biospecimens are released according to IRB-approved protocol.
- Ensure the security and confidentiality of stored biospecimen.
- Distribute biospecimen.
- Track acquisitions and release of data/human biospecimens.
2. Acceptable Biospecimens:
- Human biospecimen stored in the CTRU Biorepository must have IRB approval and informed consent documents permitting future use by the participant.
3. Human Biospecimens:
- Includes a wide range of human specimen types, which may include:
- Sub-cellular components such as DNA or RNA
- Cells or tissues from any part of the human body
- Organs such as liver, bladder, kidney, heart, placenta, etc.
- Gametes (ova and sperm)
- Embryos and fetal tissues
- Stem cells
- Bodily products such as teeth, hair, nail clippings, sweat, urine, feces
- Blood and blood fractions, such as plasma, serum, buffy coat, red blood cells
- Saliva and buccal cells
4. Information Required and Request of Use:
- General Information
- Research study title
- PI name
- Purpose of repository
- What is the purpose?
- Description of repository
- What kind of biospecimens will be included in the repository? Provide details for each of the following for each kind of specimen:
- Biospecimen to be collected.
- How will the biospecimen be collected?
- Where will the collection occur?
- How long will the biospecimens be stored?
- How will the biospecimen be destroyed?
- Will the biospecimen be identifiable?
- What kind of biospecimens will be included in the repository? Provide details for each of the following for each kind of specimen:
- Description for other investigators who want access to the repository
- How will other investigators request biospecimen from the repository?
- Information and sharing
- Provide details for each of the following for each kind of biospecimen:
- Biospecimen to be collected.
- Will the investigator need IRB approval?
- Will a Certificate of Confidentiality be obtained to protect the confidentiality of the repository biospecimen?
- Will the investigator be required to sign documents? If ‘Yes,’ specify which documents.
- Provide details for each of the following for each kind of biospecimen:
- Security and confidentiality measures
- Describe the plan to protect identifiers, as applicable, from improper use or disclosure.
- How will biospecimen be transferred securely?
5. Identifiable Biospecimens
- Separate IRB approval will be required for each specific human participant research activity that uses identifiable biospecimen from the CTRU Biorepository.
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 |
| FDA Guidance for Industry | Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009 |
| 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