Free Biospecimen Collection Consent Form Template

Informed Consent for Biospecimen Collection, Storage, and Future Research

Patient Informed Consent Documentation

Participant and Biospecimen Information

1. Purpose and Collection of Biospecimens

Biospecimens (such as blood, tissue, saliva, or urine) contain valuable biological molecules including DNA, proteins, and cells. Researchers study these specimens to understand disease mechanisms, identify genetic risk factors, and develop new treatments or diagnostic tests. By signing this form, you agree to donate a biospecimen to our biobank. The specimen may be collected during a dedicated visit (such as a blood draw), or it may consist of excess tissue that is left over from a scheduled surgery or biopsy. The specimen will be processed and stored indefinitely in a secure facility for future, unspecified research.

2. Genetic and DNA Sequencing Disclosures

3. Specimen Ownership and Commercialization Waiver

By signing this form, you donate your biospecimen to the research institution. The specimen becomes the property of the biobank. You waive any rights to the sample and understand that you will not receive any financial compensation or royalties if research using your specimen leads to a commercialized product, patent, or diagnostic test. You will not have access to any commercial profits or intellectual property resulting from the study.

4. Risks and Disclosures

5. De-identification and Biobank Security

All biospecimens stored in the biobank are de-identified (coded). Your name, date of birth, and MRN are removed and replaced with a unique code. The key linking the code to your identity is stored in a separate, encrypted database accessible only to authorized biobank coordinators. Researchers who receive samples from the biobank only receive coded specimens and are legally prohibited from attempting to re-identify participants.

6. Alternatives to Donation

7. Right to Withdraw Consent and Samples

You have the right to withdraw your consent at any time. Your request must be submitted in writing. Once received, the biobank will destroy any of your unused biospecimens remaining in storage and delete your clinical data link. However, you understand that samples or data that have already been distributed to researchers or used in completed studies before your request was processed cannot be recalled or destroyed.

8. IRB Oversight and Rights

This biospecimen collection protocol has been reviewed and approved by an Institutional Review Board (IRB) to protect participant rights. If you have questions about your rights as a research participant, you can contact the IRB office at [IRB contact information].

9. Participant Understanding and Questions

I confirm that I have read this document and understand the biospecimen collection and biobanking program, the genetic disclosures (GINA), the waiver of commercial rights, the privacy risks, and my right to withdraw my samples. All my questions have been answered.

10. Language Access Services

If English is not your primary language, a qualified interpreter is available at no cost. Please inform staff before signing.

11. Copy of Consent Acknowledgment

I acknowledge that I have been offered a copy of this signed consent form.

12. Participant Authorization

I voluntarily consent to the collection and storage of my biospecimens for future research as described. I authorize genetic sequencing if required by research protocols. I understand the commercial waiver and agree to the storage terms.

Signatures and Verification