Clinical Trial Informed Consent Form

CLINICAL TRIAL INFORMED CONSENT FORM

TABLE OF CONTENTS

1. Key Information Summary
2. Study Information
3. Purpose of the Research
4. Study Procedures
5. Risks and Discomforts
6. Benefits
7. Alternatives to Participation
8. Costs and Compensation
9. Confidentiality
10. Voluntary Participation and Withdrawal
11. Injury and Compensation for Harm
12. Contact Information
13. Consent Signatures

STUDY IDENTIFICATION

Study Title: [________________________________]
Protocol Number: [________________________________]
Sponsor: [________________________________]
IRB Name: [________________________________]
IRB Protocol Number: [________________________________]
IRB Approval Date: [__/__/____]
IRB Expiration Date: [__/__/____]
Principal Investigator: [________________________________]
Study Site: [________________________________]

1. KEY INFORMATION SUMMARY

You are being invited to take part in a research study. Your participation is voluntary. Please read this form carefully before deciding whether to participate.

Why is this study being done?
[________________________________]

What will happen if you take part?
[________________________________]

How long will the study last?
[________________________________]

What are the main risks?
[________________________________]

What are the possible benefits?
[________________________________]

What are the alternatives?
[________________________________]

Will it cost you anything?
[________________________________]

Will you be paid?
[________________________________]

2. STUDY INFORMATION

2.1 Investigator and Institutional Information

Principal Investigator: [________________________________]
Title/Department: [________________________________]
Institution: [________________________________]
Address: [________________________________]
Phone: [________________________________]
Email: [________________________________]

Co-Investigator(s): [________________________________]

2.2 Funding Source: [________________________________]

2.3 Study Phase: ☐ Phase I ☐ Phase II ☐ Phase III ☐ Phase IV ☐ N/A

2.4 Number of Participants: Approximately [____] participants will be enrolled at this site. Approximately [____] participants will be enrolled nationwide/worldwide.

3. PURPOSE OF THE RESEARCH

3.1 The purpose of this research study is to:
[________________________________]

3.2 This study is being conducted because:
[________________________________]

3.3 Investigational Product/Intervention:
[________________________________]

3.4 The U.S. Food and Drug Administration (FDA) has:
☐ Approved the investigational product for the condition being studied
☐ Approved the investigational product for other conditions but NOT for the condition being studied
☐ NOT approved the investigational product for any condition

4. STUDY PROCEDURES

4.1 Screening Procedures:
[________________________________]

4.2 Study Schedule:

4.3 Randomization and Blinding:
☐ This study involves randomization (assignment to a treatment group by chance)
☐ This study is single-blinded (you will not know which treatment you receive)
☐ This study is double-blinded (neither you nor the investigator will know which treatment you receive)
☐ This study includes a placebo group (inactive treatment)
☐ This study is open-label (all parties know the treatment assignment)

4.4 Samples and Specimens:
☐ Blood draws (approximately [____] mL per visit)
☐ Tissue samples/biopsy
☐ Urine samples
☐ Genetic/genomic testing
☐ Other: [________________________________]

Storage and Future Use of Samples:
☐ Samples will be destroyed after study completion
☐ Samples may be stored for future research related to this study
☐ Samples may be stored for future unrelated research (separate consent below)

5. RISKS AND DISCOMFORTS

5.1 Risks of the Investigational Product/Intervention:

Common risks (occurring in more than 10% of participants):
[________________________________]

Less common risks (occurring in 1-10% of participants):
[________________________________]

Rare risks (occurring in less than 1% of participants):
[________________________________]

Unknown risks: There may be risks that are currently unknown or not yet identified.

5.2 Risks of Study Procedures:
[________________________________]

5.3 Reproductive Risks:
[________________________________]

5.4 Risk of Loss of Confidentiality: Despite safeguards, there is a risk that your research records could be seen by unauthorized persons.

6. BENEFITS

6.1 Possible benefits to you from participation include:
[________________________________]

6.2 You may not personally benefit from participation in this study.

6.3 Possible benefits to others or to science include:
[________________________________]

7. ALTERNATIVES TO PARTICIPATION

7.1 Alternatives to participating in this study include:
[________________________________]

7.2 You may choose not to participate in this study and continue with your current treatment plan. Your regular medical care will not be affected by your decision.

8. COSTS AND COMPENSATION

8.1 Costs to You:
☐ There is no cost to you for the study drug/device/intervention
☐ Standard-of-care procedures will be billed to you/your insurance
☐ The following costs may be your responsibility: [________________________________]

8.2 Compensation:
☐ You will receive $[________________________________] per visit for your time and travel
☐ You will receive $[________________________________] total for completing the study
☐ Payment schedule: [________________________________]
☐ You will not receive compensation for participation
☐ Prorated payment if you withdraw: [________________________________]

9. CONFIDENTIALITY

9.1 Your research records will be kept confidential to the extent permitted by law. Your name will not appear in any publication resulting from this study.

9.2 The following persons or entities may review your research and medical records:

• The research team at [________________________________]
• The IRB at [________________________________]
• The study Sponsor: [________________________________]
• The U.S. Food and Drug Administration (FDA)
• The Office for Human Research Protections (OHRP)
• Data Safety Monitoring Board (if applicable)

9.3 Certificate of Confidentiality:
☐ This research is covered by a Certificate of Confidentiality issued by the National Institutes of Health (NIH). This Certificate helps protect your privacy by prohibiting disclosure of identifiable research information in response to legal demands, except as described below.
☐ This research is not covered by a Certificate of Confidentiality.

9.4 HIPAA Authorization. Your participation involves the use and disclosure of your Protected Health Information (PHI) as described in the separate HIPAA Authorization form attached hereto.

10. VOLUNTARY PARTICIPATION AND WITHDRAWAL

10.1 Your participation in this research study is entirely voluntary. You may choose not to participate without any penalty or loss of benefits to which you are otherwise entitled.

10.2 You may withdraw from the study at any time. Your withdrawal will not affect your current or future medical care.

10.3 If you withdraw, the investigator may ask you to complete a final exit visit for safety monitoring purposes. You may decline.

10.4 The investigator or sponsor may end your participation without your consent if:

• It is in your best medical interest;
• You do not follow study instructions;
• The study is stopped by the sponsor, IRB, or regulatory agency; or
• Other administrative reasons arise.

10.5 Data Already Collected. If you withdraw, data collected prior to your withdrawal:
☐ May continue to be used in the research analysis
☐ Will be destroyed upon your written request (to the extent permitted by law)

11. INJURY AND COMPENSATION FOR HARM

11.1 If you are injured as a direct result of your participation in this study:
[________________________________]

11.2 By signing this form, you are not waiving any of your legal rights or releasing the investigator, institution, or sponsor from liability for negligence.

12. CONTACT INFORMATION

For questions about the research:
Principal Investigator: [________________________________]
Phone: [________________________________]
Email: [________________________________]

For questions about your rights as a research subject:
IRB Name: [________________________________]
Phone: [________________________________]
Email: [________________________________]

In case of a research-related injury or emergency:
24-Hour Contact: [________________________________]
Phone: [________________________________]

13. CONSENT SIGNATURES

STATEMENT OF CONSENT

I have read this consent form (or it has been read to me). I have had the opportunity to ask questions and have received satisfactory answers. I voluntarily agree to participate in this research study.

☐ I consent to participate in this research study.
☐ I consent to the storage of my samples for future research related to this study.
☐ I consent to the storage of my samples for future unrelated research.
☐ I consent to be contacted about future research studies.

Participant Signature: [________________________________]
Printed Name: [________________________________]
Date: [__/__/____]

Legally Authorized Representative (if applicable):
Signature: [________________________________]
Printed Name: [________________________________]
Relationship: [________________________________]
Date: [__/__/____]

Person Obtaining Consent:
Signature: [________________________________]
Printed Name: [________________________________]
Title: [________________________________]
Date: [__/__/____]

Witness (if required by IRB or applicable regulation):
Signature: [________________________________]
Printed Name: [________________________________]
Date: [__/__/____]

SOURCES AND REFERENCES

• 45 C.F.R. § 46.116 — Informed Consent Requirements
• 21 C.F.R. Part 50 — Protection of Human Subjects
• FDA Informed Consent Guidance
• OHRP Informed Consent FAQs
• ICH E6(R2) Good Clinical Practice