Clinical Research Consent Template

INFORMED CONSENT FOR RESEARCH PARTICIPATION

Study Title: Full Title of Research Study

Protocol Number: Protocol ID

Principal Investigator: Name, Title, Institution

Sponsor: Funding source or sponsor

Date: Date

PARTICIPANT INFORMATION

Name: Participant Full Name

Date of Birth: DOB

Contact Phone: Phone

Email: Email

Address: Address

1. INVITATION TO PARTICIPATE

You are being invited to take part in a research study. Before you decide whether to participate, it is important for you to understand why the research is being done and what it will involve.

Please:

• Read this form carefully
• Ask questions about anything unclear
• Take time to decide
• Discuss with family/friends if desired
• You do not have to participate

2. PURPOSE OF THE STUDY

Why is this research being conducted?

Explain purpose and background of the research in layman's terms

Research Question:

This study aims to research question/hypothesis.

Why have I been invited?

You have been invited because inclusion rationale. We plan to enroll approximately Number participants.

3. VOLUNTARY PARTICIPATION

Your participation is entirely voluntary.

• You do not have to take part
• Declining will not affect your medical care or other benefits
• You may withdraw at any time without giving a reason
• Withdrawal will not affect your medical care/grades/employment/etc.

4. STUDY PROCEDURES

What will happen if I take part?

Duration:

• Total study length: Duration
• Your participation: Duration
• Number of visits: Number
• Visit duration: Approximately Time each

Procedures:

Screening Phase:

• Review of eligibility criteria
• Medical history
• Screening tests/procedures
• Estimated time: Duration

Study Phase:

Detailed description of what participant will be asked to do, including:

• Questionnaires or surveys: Topics, frequency, duration
• Interviews: Format, frequency, duration
• Physical examinations: What will be examined
• Blood draws: Number, amount, frequency
• Imaging studies: Type, frequency
• Medication/intervention: What, dose, frequency, duration
• Procedures: Detailed description
• Follow-up visits: Schedule
• Diary or logs: What to record, frequency

Randomization (If Applicable):

• You will be randomly assigned (like flipping a coin) to one of Number groups
• Percentage% chance of receiving Treatment A
• Percentage% chance of receiving Treatment B
• Percentage% chance of receiving placebo/standard treatment
• Neither you nor the investigator can choose your group
• You will/will not be told which group you're in
• Blinded/Double-blinded study

Sample Collection:

• Blood: Amount (about X tablespoons) on Number occasions
• Urine: Amount and frequency
• Tissue: Type and procedure
• Other biological samples

How samples will be used:

• Analysis for this study
• Future research (with/without re-consent)
• Genetic testing: Yes/No

5. RISKS AND DISCOMFORTS

Participation involves the following risks:

Likely Risks (Common):

• Risk 1: Description, how common, how managed
• Risk 2: Description, how common, how managed
• Risk 3: Description, how common, how managed

Less Likely Risks (Uncommon):

• Risk 1: Description
• Risk 2: Description

Rare but Serious Risks:

• Risk 1: Description
• Risk 2: Description

Procedure-Specific Risks:

• Blood draw: Bruising, bleeding, infection, fainting
• Specific procedure: Specific risks

Unknown Risks:

• This is research and unforeseen risks may occur
• New information about risks will be shared with you
• May require withdrawal from study

Minimizing Risks:

Describe how risks will be minimized and monitored

Reproductive Risks:

• Women of childbearing potential: Requirements for contraception, pregnancy testing
• Should not become pregnant during study
• Should not breastfeed during study
• Men: Requirements if applicable
• Notify immediately if pregnancy occurs

6. POTENTIAL BENEFITS

Benefits to You:

• Direct benefit: Describe potential therapeutic benefit
• No direct benefit expected
• Access to experimental treatment
• Close medical monitoring
• Health information from tests
• Other benefits

Important:

• Benefits are not guaranteed
• You may receive no benefit
• The treatment may not work for you

Benefits to Others:

• Information gained may help future patients
• Advance medical knowledge
• Specific benefit to society/field

7. ALTERNATIVES TO PARTICIPATION

Alternatives include:

• Standard treatment option 1
• Standard treatment option 2
• No treatment/watchful waiting
• Other research studies
• Other alternatives

You may choose these alternatives instead of participating.

8. CONFIDENTIALITY

Your privacy will be protected:

Identifiable Information:

• Name, contact information, medical record number
• Kept separate from research data
• Accessible only to authorized study staff
• Stored securely

Research Data:

• Coded with participant ID number
• No direct identifiers in research records
• Stored securely locked files/encrypted computer

Who May See Your Information:

• Study team
• Institutional Review Board (IRB)
• Sponsor/funding agency
• Regulatory agencies (FDA, etc.)
• Data safety monitoring board
• Study monitors/auditors

Limits to Confidentiality:

• Required reporting: Child abuse, danger to self/others, communicable diseases
• Subpoena (will be resisted to extent possible)
• Cannot guarantee absolute confidentiality

Published Results:

• Results may be published
• You will not be identified
• Aggregate/group data only

Certificate of Confidentiality (If Applicable):

• Study has Certificate of Confidentiality from Agency
• Protects against forced disclosure in legal proceedings
• Does not prevent voluntary disclosure
• Does not prevent required reporting of certain events

Health Information:

• Use subject to Health Insurance Portability and Accountability Act (HIPAA)
• See separate HIPAA authorization or integrated below

Future Research:

• Samples/data may be used for future research
• With your permission
• De-identified samples may be shared
• You will not be re-contacted for consent

9. COMPENSATION

For Participation:

• No compensation provided
• Stipend: Amount per visit, total up to Total Amount
• Payment for time and travel: Amount
• Parking validated
• Meals provided
• Other compensation

Payment Schedule:

When and how payment will be made

If You Withdraw:

• You will be paid for visits completed
• Prorated payment: Details

Tax Information:

• Payments over \$600 will be reported to IRS
• SSN may be required

10. COSTS

Study-Related Costs:

• No cost to participate
• Study procedures provided at no cost
• Study medication provided at no cost

Costs You May Incur:

• Transportation to study site
• Parking (if not validated)
• Time off work
• Other costs

Insurance:

• Your insurance will/will not be billed for non-study procedures
• You may be responsible for copays/deductibles for routine care

11. COMPENSATION FOR INJURY

If you are injured as a direct result of study participation:

• Medical treatment will be available
• Costs will be covered by: Sponsor/Institution/No coverage
• No compensation for lost wages or pain and suffering
• Does not waive legal rights

Reporting Injury:

Contact immediately: Principal Investigator Name and 24-hour phone

This does not waive any legal rights you may have.

12. VOLUNTARY WITHDRAWAL

You may withdraw at any time for any reason.

To Withdraw:

• Inform study staff: Name and contact
• No penalties
• No loss of benefits
• Medical care continues (if applicable)

Investigator May Withdraw You If:

• Not following study requirements
• For your safety
• Study is stopped
• Other reasons

If You Withdraw:

• Data collected up to that point may still be used
• Samples already collected will/may be used
• May need follow-up visit for safety
• May be contacted about your health status

13. NEW FINDINGS

You will be informed of:

• New information that may affect your willingness to participate
• Significant changes to study procedures
• New risks discovered

You may be asked to:

• Re-consent if significant changes occur

14. STUDY RESULTS

Access to Results:

• Individual results will/will not be shared with you
• If clinically significant findings, you will be informed
• Summary of study results available after completion
• Results expected to be available: Timeframe

Clinically Significant Findings:

Describe what will be shared and how, e.g., genetic findings, incidental findings on imaging

15. COMMERCIAL DEVELOPMENT

Future Commercial Products:

• Research may lead to commercial products or discoveries
• You will not receive financial benefit from commercialization
• Sponsor/institution may benefit financially
• Patents may result; you will have no rights to patents

16. STUDY CONTACTS

For Questions About the Study:

Principal Investigator: Name Phone: 24-hour number Email: Email

Study Coordinator:

Name: Name

Phone: Phone Email: Email

For Questions About Your Rights as a Research Participant:

Institutional Review Board (IRB): Institution Name Phone: Phone Email: Email Address: Address

For Reporting Problems or Injuries:

Call Name immediately at Phone (24 hours)

For Emergency:

Call 911 or go to nearest emergency room

17. CONSENT

By signing this form, I confirm:

• I have read this consent form (or it has been read to me)
• I have had opportunity to ask questions
• My questions have been answered to my satisfaction
• I understand the purpose of the study
• I understand the study procedures
• I understand the risks and potential benefits
• I understand participation is voluntary
• I may withdraw at any time
• I understand confidentiality and its limits
• I understand compensation and costs
• I have received or will receive a copy of this signed consent
• I freely agree to participate in this research study

Optional Consents:

I consent to:

• Being contacted for future research studies
• Storage and future use of my samples/data for other research
• Sharing of de-identified data with other researchers
• Video/audio recording during study procedures
• Genetic testing on my samples
• Return of individual research results (if any)

I do NOT consent to:

• Contact for future research
• Future use of samples/data

SIGNATURES:

Participant:

I voluntarily agree to participate in this research study.

Signature: _______________________

Printed Name: Participant Name

Date: _______________________

Time: _______________________

Legally Authorized Representative (If Applicable):

I am authorized to consent on behalf of the participant.

Signature: _______________________

Printed Name: Name Relationship to Participant: Relationship Authority: Legal basis

Date: _______________________

Time: _______________________

Person Obtaining Consent:

I have explained the study to the participant/representative and answered all questions.

Signature: _______________________

Printed Name: Name Title/Role: Title

Date: _______________________

Time: _______________________

Witness (If Required):

I witnessed the consent process.

Signature: _______________________

Printed Name: Name

Date: _______________________

Time: _______________________

Interpreter (If Applicable):

I have accurately interpreted the contents of this consent form.

Signature: _______________________

Printed Name: Name Language: Language

Date: _______________________

COPIES:

• Participant copy
• Investigator/medical record copy
• Study file copy

IRB Approval: This study has been reviewed and approved by IRB Name on Date. Approval expires Date.