What is a Certificate of Confidentiality?

A Certificate of Confidentiality is issued under 42 USC § 241(d) by the National Institutes of Health (NIH) and other HHS agencies. It protects identifiable, sensitive research information from compelled disclosure in federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As of October 2017, NIH automatically issues Certificates for all NIH-funded research involving identifiable, sensitive information. Statutory exceptions include FDA inspections, federal audits of the research, and disclosure required by federal, state, or local law for public-health reporting (e.g., child abuse, communicable disease).

Can I withdraw from a research study after I have signed?

Yes, at any time, without penalty or loss of benefits. Withdrawal is one of the basic elements of informed consent (45 CFR § 46.116(b)(8)). The study team typically requests a final safety visit and may continue to use information already collected up to the point of withdrawal — this is permitted under § 46.116(b)(9) and 21 CFR § 50.25 if disclosed in the consent form. You can also withdraw permission for future use of your biospecimens going forward, though specimens already used cannot be retrieved.

What about research with children or other vulnerable populations?

45 CFR Part 46 has additional subparts for special populations: Subpart B (pregnant women, fetuses, neonates), Subpart C (prisoners), Subpart D (children — requires both parental permission AND, for children capable of assent, child assent under § 46.408). FDA adds 21 CFR Part 50 Subpart D for FDA-regulated pediatric research. The level of permitted risk is generally limited and varies by subpart. Adult subjects who lack decision-making capacity (e.g., dementia patients) require a legally authorized representative under state law and additional IRB review.

What if a participant does not speak English?

The consent process must be in a language understandable to the participant. Two options: (1) Translate the full consent form into the participant's language and have it IRB-approved; (2) Use the "short form" consent process under 45 CFR § 46.117(b)(2): a brief written summary in the participant's language confirming the elements of consent were presented orally, plus an English-language version of the consent form, with a witness who speaks both languages and signs both. Option 1 is preferred for routine use; option 2 is appropriate for unanticipated enrollment of a non-English speaker.

Research Informed Consent Form (Common Rule)

Informed consent for human-subjects research compliant with 45 CFR § 46.116 (Revised Common Rule, 2018) — includes key information section, risks/benefits, IRB contacts.

Customise

Study title

Short title (for headers)

Protocol number

Sponsor / funder

Principal investigator (name + credentials)

PI — 24/7 contact phone

Study site

Site address

Reviewing IRB

IRB contact

IRB study/approval number

Purpose of the study (plain language)

How long participation will last

Approximate number of participants

Procedures (what participants do)

Reasonably foreseeable risks

Reasonably expected benefits

Alternative procedures or treatments

Confidentiality protections

Compensation / treatment for research-related injury

Voluntary participation / withdrawal

Future use of identifiable data or biospecimens

Who to contact with questions

Consent date

Participant — printed name

Live preview

INFORMED CONSENT FOR RESEARCH PARTICIPATION
A Phase II Study of Compound XYZ-401 in Adults with Treatment-Refractory Migraine

Protocol: XYZ-401-2026-002
IRB approval #: IRB-2026-04477
Sponsor: Acme Pharmaceuticals, Inc.
Principal investigator: Dr. Lin Chen, MD, PhD
Study site: OHSU Headache Research Center
3181 SW Sam Jackson Park Rd, Portland, OR 97239

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KEY INFORMATION (45 CFR § 46.116(a)(5)(i))
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You are being asked to take part in a research study. Participation is
voluntary. The information below summarizes the key facts you should
know to decide whether to take part. The full consent form follows.

• PURPOSE: The purpose of this research is to find out if a study drug called XYZ-401 reduces migraine frequency in adults who have not responded to standard preventive medications. The study compares XYZ-401 to placebo (an inactive substance that looks the same).
• DURATION: Approximately 28 weeks: 4-week screening, 16-week treatment, 8-week follow-up.
• PROCEDURES: This study involves a study drug (or placebo), in-person
visits, blood draws, ECGs, and questionnaires.
• MAIN RISKS: Injection-site reactions, possible liver enzyme changes,
rare allergic reactions, unknown risks of an investigational drug.
• MAIN BENEFITS: Possible reduction in migraine frequency. Half of
participants receive placebo and may receive no direct benefit.
• ALTERNATIVES: Several FDA-approved treatments are available outside
the study; no treatment is also an option.

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1. STATEMENT THAT THIS IS RESEARCH (45 CFR § 46.116(b)(1))
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This is a research study. The treatment you receive in this study is
investigational — it has not been approved by the U.S. Food and Drug
Administration for the prevention of migraine. The purpose of research
is to develop generalizable knowledge.

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2. PURPOSE, DURATION, AND PROCEDURES
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PURPOSE
The purpose of this research is to find out if a study drug called XYZ-401 reduces migraine frequency in adults who have not responded to standard preventive medications. The study compares XYZ-401 to placebo (an inactive substance that looks the same).

DURATION OF YOUR PARTICIPATION
Approximately 28 weeks: 4-week screening, 16-week treatment, 8-week follow-up.

NUMBER OF PARTICIPANTS
180 participants across 12 sites in the United States and Canada.

PROCEDURES
During the study you will:
• Attend 8 in-person visits at the study site (approximately 1-2 hours each).
• Complete a daily migraine diary on your phone.
• Receive a study drug or placebo by self-injection once every 4 weeks.
• Have blood drawn for safety labs at 6 visits (about 2 tablespoons each time).
• Have an electrocardiogram (ECG) at 3 visits.
• Complete questionnaires about your headaches, mood, and quality of life.
• Be reimbursed $75 per completed visit (up to $600 total).

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3. REASONABLY FORESEEABLE RISKS OR DISCOMFORTS (§ 46.116(b)(2))
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Common side effects of XYZ-401 in earlier studies (>10% of participants):
• Injection-site reactions (redness, pain) — usually mild, resolve within 24 hours.
• Mild fatigue or headache (paradoxically) — usually mild, transient.
Uncommon side effects (1-10%):
• Mild liver enzyme elevation — monitored by blood tests.
• Mild upper respiratory infection symptoms.
Serious but rare side effects (<1%):
• Allergic reaction (anaphylaxis) — emergency treatment required.
• Liver injury — may require discontinuation.
Unknown risks: Because this is an investigational drug, there may be risks that are not yet known.
Risks of blood draws: minor bruising, brief discomfort.
Loss of confidentiality: see Confidentiality section. Loss of time and inconvenience.

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4. REASONABLY EXPECTED BENEFITS (§ 46.116(b)(3))
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You may experience reduction in migraine frequency or severity if you receive the active study drug. However, half of participants will receive placebo and may receive no direct benefit. Benefits to others: information learned from this study may help future migraine patients.

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5. ALTERNATIVES TO PARTICIPATION (§ 46.116(b)(4))
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You do not have to take part in this research. Standard FDA-approved treatments for migraine prevention are available outside the study, including: topiramate, propranolol, amitriptyline, onabotulinumtoxinA, and CGRP-receptor antagonists (erenumab, fremanezumab, galcanezumab, eptinezumab). You may also choose no preventive treatment.

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6. CONFIDENTIALITY (§ 46.116(b)(5))
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Your study records will be kept confidential to the extent permitted by law. Records may be reviewed by:
• The study sponsor and its contractors.
• The U.S. Food and Drug Administration (FDA).
• The reviewing IRB.
• The Office for Human Research Protections (OHRP).
Results will be reported in scientific publications without identifying you. The study has a Certificate of Confidentiality from the National Institutes of Health (42 USC § 241(d)) which protects against compelled disclosure in legal proceedings, with limited exceptions.

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7. RESEARCH-RELATED INJURY (§ 46.116(b)(6))
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If you are injured as a direct result of taking part in this research, the sponsor will pay for reasonable and necessary medical treatment of the injury. The sponsor will not pay for treatment of injuries that result from the underlying disease or from non-research-related causes. There is no other compensation available for research injury. By signing this form you do not give up any of your legal rights.

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8. VOLUNTARY PARTICIPATION (§ 46.116(b)(8))
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Taking part in this research is voluntary. You may decline to participate or withdraw at any time without penalty or loss of benefits to which you are otherwise entitled. Your decision will not affect your medical care at this institution. If you withdraw, the study team will ask you to attend a final safety visit and will continue to use information already collected.

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9. FUTURE USE OF DATA / BIOSPECIMENS (§ 46.116(b)(9))
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Your election regarding future research use:

I consent to future research use of de-identified data and biospecimens

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10. CONTACTS (§ 46.116(b)(7))
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For questions about the research or research-related injury: contact the principal investigator (above).
For questions about your rights as a research participant or to report a complaint: contact the IRB (above).

PI 24/7 contact: +1 503 494 8311 (24/7)
IRB contact: irb@ohsu.edu, +1 503 494 7887 (OHSU Institutional Review Board)

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11. SIGNATURES
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By signing below, I confirm that:

• I have read this consent form (or it has been read to me).
• I have had an opportunity to ask questions and my questions have
been answered to my satisfaction.
• I voluntarily agree to participate in this research.
• I will receive a signed copy of this form.

_____________________________________ May 11, 2026
Participant signature Date

Participant — printed name: Jordan Alex Taylor

_____________________________________ May 11, 2026
Person obtaining consent — signature Date

Person obtaining consent — printed name + role: ____________________

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COPY TO PARTICIPANT — ORIGINAL TO STUDY RECORD
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About this template

A research informed consent form is the foundational document of human-subjects research. The Federal Policy for the Protection of Human Subjects (the "Common Rule" — codified for HHS at 45 CFR Part 46, with parallel adoption by 19 other federal agencies) was substantially revised in 2017-2018 to require what is called the "Key Information" section: a concise focused presentation of the most important facts at the very beginning of the consent form, organized to facilitate the prospective subject's understanding of why they might or might not want to participate (45 CFR § 46.116(a)(5)(i)). This requirement reflected decades of research showing that subjects routinely sign consent forms they have not read or understood. The Common Rule also requires the basic elements of informed consent under § 46.116(b): (1) a statement that the study involves research and a description of purpose, duration, and procedures; (2) reasonably foreseeable risks; (3) reasonably expected benefits to the subject and others; (4) alternatives; (5) confidentiality protections; (6) compensation and treatment for research injury (for studies involving more than minimal risk); (7) contacts for the research and for participant rights questions; (8) voluntary participation with no penalty for withdrawal; (9) statements regarding future research use of identifiable data or biospecimens; (10) for biospecimens, whether they may be used for commercial profit; (11) clinically relevant research results; and (12) for research that involves whole genome sequencing, that information. Studies involving FDA-regulated investigational products are subject to additional FDA regulations at 21 CFR Part 50 (parallel to but not identical to the Common Rule); when both apply, the more stringent requirement governs. Studies involving Medicare or Medicaid beneficiaries may have additional disclosure requirements about cost. Pediatric research is subject to 45 CFR Part 46 Subpart D (assent and parental permission requirements). Research with prisoners, pregnant women, fetuses, and neonates have specific subparts as well. The IRB (Institutional Review Board) is required to review and approve every consent form before use; modifications during the study require IRB approval before implementation. The Certificate of Confidentiality (issued under 42 USC § 241(d)) protects research records against compelled disclosure in many legal proceedings, with statutory exceptions for federal audits, FDA inspections, and certain mandatory reporting (child abuse, communicable diseases). The form must be written at a reading level appropriate for the population (typically 6th-8th grade). Translations are required for non-English-speaking participants; the "short form" consent process under § 46.117(b)(2) allows a brief written summary in a language the subject understands plus an oral consent process witnessed by a third party, but is not preferred for routine use. The doctrine of informed consent in research traces to the Nuremberg Code (1947), the Declaration of Helsinki (World Medical Association, 1964 with multiple revisions), and the Belmont Report (1979) which articulated the three foundational principles: respect for persons, beneficence, and justice. The Common Rule operationalizes these. This template targets a typical Phase II clinical drug trial; specific study types (genetic studies, behavioral studies, observational studies, exempt research, expedited research) have additional or modified consent requirements. Consult your IRB before adapting this form for a specific study.

When to use it

Enrolling subjects in a clinical drug or device trial.
Enrolling subjects in a behavioral or observational research study.
Collecting biospecimens for research use.
Conducting any research that meets the Common Rule definition of human-subjects research (45 CFR § 46.102).
When required by IRB approval letter for ongoing study consent.

What to include

Key Information section at the start (concise, focused, decision-relevant).
Statement that this is research and the treatment is investigational.
Purpose, duration, number of participants, procedures.
Reasonably foreseeable risks (with rough probabilities where known).
Reasonably expected benefits to participant and to society.
Alternatives including no treatment.
Confidentiality protections including Certificate of Confidentiality if applicable.
Research-injury compensation statement.
Voluntary-participation and withdrawal-without-penalty statement.
Future-use-of-data election.
24/7 PI contact and IRB contact for participant rights.
Signatures of participant and person obtaining consent with date.

Frequently asked

Under 45 CFR § 46.116(a)(5)(i), informed consent must begin with "a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research." This section must be organized to facilitate comprehension. There is no fixed length, but most IRBs expect 1-2 pages. It should cover: the study is research; why one might or might not participate; purpose; duration; procedures; main risks; main benefits; alternatives.

⚠ Legal disclaimer. Research informed consent in the United States is governed by the Federal Policy for the Protection of Human Subjects (the Common Rule), codified for HHS at 45 CFR Part 46 and adopted by 19 other federal agencies. FDA-regulated research is additionally governed by 21 CFR Parts 50 and 56. The 2018 Revised Common Rule (effective January 21, 2019) added the Key Information requirement, expanded waiver criteria, and updated requirements for biospecimen research. Vulnerable populations have additional protections under Subparts B (pregnant women / fetuses / neonates), C (prisoners), and D (children) of 45 CFR Part 46. International research is additionally governed by the Declaration of Helsinki (World Medical Association) and host-country regulations. Source references: 45 CFR Part 46 (HHS regulations); 21 CFR Parts 50 and 56 (FDA regulations); Belmont Report (HHS, 1979); OHRP guidance at hhs.gov/ohrp; ClinicalTrials.gov registration requirements (42 USC § 282(j)). Every research consent form must be reviewed and approved by an IRB before use. Not legal or medical advice — consult your IRB and a regulatory attorney for specific situations.

Jurisdiction: United States — Federal Policy for the Protection of Human Subjects (Common Rule), 45 CFR Part 46 (esp. §46.116 informed consent, §46.117 documentation); FDA human-subjects regulations, 21 CFR Part 50 (Protection of Human Subjects) + 21 CFR Part 56 (IRBs); ICH-GCP E6(R3) (FDA-recognized Good Clinical Practice guidance); 42 U.S.C. §241(d) (NIH Certificate of Confidentiality).

Last reviewed: 2026-05

Reviewed by ScoutMyTool — consult a licensed attorney for binding use.