Informed Consent in Emerging Treatments
What informed consent means, what U.S. research rules say a consent process must cover, and why a signed form for an emerging treatment does not show the treatment is approved or safe.
Content last updated . This page has not been medically reviewed.
What informed consent is
Informed consent means a person agrees to a test or treatment after being told what it involves, and without pressure. The NHS in England describes valid consent as voluntary, informed and given by someone with the capacity to decide. [1] The U.S. National Library of Medicine's MedlinePlus describes the same idea: your providers must explain your health condition and treatment choices, and you may refuse. [2]This page is information only. It describes official rules and what they say. It is not legal advice and not a recommendation for or against any treatment. Rules differ by country and change over time. This page reads two U.S. federal research rules, plus the NHS (England) and MedlinePlus (U.S.) descriptions of consent in ordinary care.
Why emerging treatments need extra care
When a treatment is new, less is known about its risks and benefits. A consent conversation is the main point where that uncertainty should be put into plain words. "Emerging" does not mean effective, approved or safe. See how we label evidence for the terms used on this site.What U.S. rules say a research consent must include
Two sets of U.S. federal rules matter. The FDA rule (21 CFR 50.25) applies to research on FDA-regulated products. The Common Rule (45 CFR 46.116) sets general consent requirements for research covered by that policy. [3] [4]| Element | What the rule says | Source |
|---|---|---|
| Research statement | The study involves research; its purpose, expected duration and procedures are described, and any procedures that are experimental are identified | 21 CFR 50.25(a)(1) [3] |
| Risks | A description of reasonably foreseeable risks or discomforts | 21 CFR 50.25(a)(2) [3] |
| Alternatives | Appropriate alternative procedures or treatments that might be advantageous | 21 CFR 50.25(a)(4) [3] |
| Injury | For research with more than minimal risk, whether compensation or medical treatment is available if injury occurs | 21 CFR 50.25(a)(6) [3] |
| Voluntary | Participation is voluntary, refusal carries no penalty, and the person may stop at any time | 21 CFR 50.25(a)(8) [3] |
| Unforeseeable risks | When appropriate, a statement that the treatment may involve risks that are currently unforeseeable | 21 CFR 50.25(b)(1) [3] |
| New findings | When appropriate, a statement that significant new findings will be shared with the person | 21 CFR 50.25(b)(5) [3] |
The Common Rule adds that consent must begin with a concise, focused presentation of the key information a reasonable person would want, and that the investigator must give enough time to consider the choice while minimizing the possibility of coercion or undue influence. [4] It also bars exculpatory language that makes a person waive or appear to waive legal rights, or that releases the investigator, sponsor or institution from liability for negligence. [4]
Consent does not equal approval
- A signed form is not a regulator's review. The FDA says unapproved regenerative medicine products require FDA approval or oversight in a clinical trial before they are marketed to consumers. [5]
- A trial listing is not approval. The FDA warns that being listed on ClinicalTrials.gov, or a firm registering with FDA, does not mean a product is legally marketed. [5]
- Charges outside a trial are a warning sign. The FDA says that if you are charged for these products or offered them outside a clinical trial, you are likely being deceived and offered a product illegally. [5]
- A disclaimer does not fix unsupported claims. See overpromising and the limits of disclaimers.
Questions the official sources suggest asking
For exosome products, the FDA (December 6, 2019 notice) tells U.S. patients to ask whether the FDA has reviewed the treatment, to ask for the Investigational New Drug application number, and to understand the entire process and known risks before signing. [6] It also notes the consent form for a trial identifies the Institutional Review Board that protects participants' rights and welfare. [6] MedlinePlus lists what a provider should explain in ordinary care: what happens during treatment, the risks and how likely they are, how likely the treatment is to work, other options, and risks that may happen later on. [2]Outside the United States
The FDA states it does not have oversight of treatments done in other countries. [6] See medical tourism for unproven treatments. Consent rules for other countries were not read for this page.Related guides
Clinical trials explained for participants, vulnerable populations and emerging interventions and informed consent in complementary care.Frequently asked questions
Does signing a consent form mean a treatment is safe?
No. Consent records that information was shared and that the person agreed. It is not an approval or safety finding. The FDA says unapproved regenerative products need FDA approval or oversight in a clinical trial. [5]
Can a consent form take away my right to sue?
Under the U.S. Common Rule, research consent may not include language that makes a person waive or appear to waive legal rights, or releases the investigator, sponsor or institution from liability for negligence. [4] Rules for ordinary clinics differ, so ask a qualified lawyer about a specific form.
What if a treatment's risks are not fully known?
FDA research rules allow a consent to state that a procedure may involve risks that are currently unforeseeable. [3] Hearing that statement is a reason to ask what is and is not known.
Can I say no or leave a study later?
Yes, for research under the FDA rule. Participation is voluntary, refusal carries no penalty, and the person may discontinue at any time without penalty or loss of benefits. [3]
Who can consent if a person cannot decide?
The NHS says that a person must have capacity to consent, and that when an adult lacks capacity clinicians act in their best interests after reasonable steps to talk with friends or relatives. [1] In U.S. research, the investigator seeks consent from the person or a legally authorized representative. [4]
References
- NHS (England). Consent to treatment. Read 2026-10-22.
- MedlinePlus (U.S. National Library of Medicine). Informed consent - adults. Read 2026-10-22.
- U.S. Code of Federal Regulations, Title 21, Section 50.25. Elements of informed consent. eCFR. Read 2026-10-22.
- U.S. Code of Federal Regulations, Title 45, Section 46.116. General requirements for informed consent. eCFR. Read 2026-10-22.
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. Posted June 3, 2021; content current as of 04/08/2024. Read 2026-10-22.
- U.S. Food and Drug Administration. Public Safety Notification on Exosome Products. December 6, 2019. Read 2026-10-22.