Before joining an MRI or fMRI research study, ask what the scan is for, who can see your images and other data, whether unexpected findings will be reviewed or shared with you, and what happens if you withdraw. A research scan may not be a clinical examination and may not diagnose or rule out a condition. The study’s consent form and research team—not general guidance—determine the answers for that particular protocol.
Start by clarifying what the scan is for
Ask whether the MRI or fMRI is being done for research, clinical care, or both. Research images may not receive the kind of review used in clinical care. Even if someone reviews them, that does not necessarily mean the scan is intended to diagnose a condition or rule one out.
- Will a qualified clinician review the images? If so, what is the review intended to do?
- Will I receive images or results? When, from whom, and with what explanation of uncertainty?
- Could the scan replace or affect any clinical care, or should I continue to rely on my usual medical care?
Ask the team to explain these limits in plain language. NIMH’s MRI Research Safety and Ethics guidance specifically recommends clarifying the distinction between research scans and clinical scans.
Ask how unexpected findings are handled
An image may raise a concern unrelated to the study’s main question. Do not assume that every image is reviewed, that every possible finding can be confirmed, or that the study will automatically provide a diagnosis. Ask for the protocol’s plan:
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- Who decides whether a possible finding needs attention?
- Who will contact me, and how will they explain what is known and uncertain?
- Could I be referred for clinical follow-up, and is any follow-up arranged by the study?
- Will I be told about every possible finding, or only findings meeting specified criteria?
NIMH’s MRI ethics guidance says a study should have a clear incidental-findings plan and that participants should be informed about it. The actual process and any return-of-results policy are specific to the study.
Find out what data are collected and who can access them
Brain images are only one possible part of a research record. Ask what else the team collects and how each type of information is handled.
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- What will be collected besides MRI or fMRI images—for example, questionnaires, recordings, health information, or identifying details?
- Where will the information be stored, for how long, and which members of the study team or partner institutions can access it?
- Are the data coded? If so, which organization keeps the key that can reconnect the code to me, and who can use that key?
- Can future researchers try to identify me, and what review or agreement governs their access?
“Coded” does not necessarily mean impossible to link to a person: a code key may still exist. NIH consent guidance distinguishes information that remains linkable through a key from information that cannot readily be linked back to an individual.
Understand future sharing and reuse
Ask whether images or other information may be shared with researchers outside the study team or placed in a research repository. Clarify the scope and conditions before agreeing:
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- Will data be shared? With whom, and through an open repository or controlled-access process?
- What future research uses are allowed or prohibited?
- Who reviews requests, and what access controls or use agreements apply?
- Does the consent form authorize future sharing, and can I decline that sharing while joining the study?
- Can already-shared data be removed if I later withdraw?
De-identification can reduce privacy risks, but it does not by itself settle every question about future use or re-identification. NIH privacy guidance recommends clear communication about sharing and appropriate protections. Consent is an opportunity to establish conditions for use and sharing; it is not itself a privacy protection.
Ask what confidentiality protections apply
Do not assume that confidentiality is absolute or that HIPAA applies to every research team and dataset. Ask the team to identify the protections that apply to this project and explain their limits.
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- Is the study covered by an NIH Certificate of Confidentiality? If so, what information is protected and what exceptions apply?
- Does HIPAA apply to the organization holding my information, and which information is covered?
- Are there circumstances in which information could or must be disclosed, such as a legal requirement or a safety concern?
NIH says investigators and institutions must inform participants about a Certificate of Confidentiality and uphold its protections. HHS describes HIPAA Privacy Rule conditions for covered entities using or disclosing protected health information for research; whether those rules apply depends on the organizations and information involved. Ask for the study’s own explanation rather than inferring coverage from the fact that it is medical research.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Know what participation and withdrawal mean
Consent is an ongoing communication process, not just a signature. Before signing, ask what is optional, how to stop participating, and what happens to information already collected.
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- Can I skip a particular scan, questionnaire, or other procedure and remain in the study?
- Can I withdraw later, and whom should I contact?
- Will information already collected be retained? Can it be removed from shared datasets?
- Who can answer questions before I decide and after I join?
- What independent contact for participant rights is listed in the consent form?
Withdrawal terms vary by study, especially once information has been analyzed or shared. Ask the team to distinguish stopping future participation from removing data already collected, and make sure the consent form states what is possible.
Use a short checklist before deciding
When comparing study invitations, focus on the terms that affect your own decision rather than assuming all studies handle them alike:
- Purpose: Is the scan research-only, clinical, or both?
- Review and findings: Who reviews images, what happens if something unexpected is suspected, and what results—if any—will be returned?
- Data: What is collected, whether it is identifiable or coded, and who holds any code key?
- Sharing: Whether data may be reused, who may access it, and what limits govern future use.
- Protections: Which confidentiality protections apply and what exceptions remain.
- Choice: Which procedures are optional and what withdrawal means for data already collected.
Read the study’s consent form and ask the research team to clarify anything unclear before deciding. General guidance can help you frame questions, but it cannot establish a particular study’s legal status, confidentiality, safety, or clinical value.
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