If you ran a prospective interventional study and no ethics committee reviewed it before the first participant was enrolled, that manuscript cannot be published — not here, and not at any journal following the Declaration of Helsinki and the COPE Core Practices. No letter obtained afterwards repairs it. No committee can approve it retrospectively.
That is the hard edge, and it comes first. What follows is for the much larger group: a submission form demanding a committee name and an approval number, a finished chart review, case report or audit, and no constituted committee in the building.
The honest answer there is not "abandon the paper", and it is certainly not "type something plausible into the field". Three legitimate routes exist. Which one applies depends on what you actually ran.
Read this only if no constituted committee exists
If a committee did review your study and you only need the wording for the approval and consent statements, read reporting ethics approval and informed consent instead.
Your national regulator overrides everything here. In India that is the national registry of ethics committees under the Department of Health Research, with CDSCO for regulated trials; in Nigeria, the National Health Research Ethics Committee. Many countries run an equivalent authority and some do not. Where you cannot establish that a registry exists for your country, say so rather than asserting one.
A prospective interventional study with no prior review is unpublishable, and nothing you do now changes that
The Declaration of Helsinki requires that research on human participants go to a research ethics committee for consideration, comment, guidance and approval before the study begins. A committee looking at a completed intervention cannot judge whether the risk to participants was justified, because the risk has already been taken.
That covers allocating participants to an intervention, changing their care for research purposes, adding a procedure or sample, or randomising anything. If no independent research ethics committee saw the protocol first, the work cannot enter the record through a journal aligned with the COPE Core Practices, and a letter obtained now documents the problem rather than solving it. The same sequencing governs public registration of trials under the ICMJE Recommendations — see clinical trial registration.
Triage your study first: four study types, four different documents actually required
The study may have needed a different document entirely, not the committee approval you are chasing. The requirements in each row follow the Declaration of Helsinki, the ICMJE Recommendations and the CIOMS International Ethical Guidelines for Health-related Research Involving Humans. Find your row before writing to anyone.
| Study type | What the work is | Document required | Who can issue it | Obtainable after data collection? | If missing |
|---|---|---|---|---|---|
| Prospective interventional study | Participants allocated, treated, randomised, or given a procedure for research | Prior committee approval of the protocol, plus participant informed consent | An independent research ethics committee, registered where a national registry operates, before enrolment | No. There is no retrospective route | Not publishable in a COPE-aligned journal; nothing created now repairs it |
| Retrospective chart or imaging review | Existing records from routine care, analysed afterwards | Committee approval, or a documented committee-granted waiver of consent | A research ethics committee — an administrator cannot grant the waiver | Yes in many jurisdictions, if the committee reviews the protocol and states the scope | A COPE-aligned journal cannot assess the study without a committee decision or a plain statement of the absence |
| Single case report or small case series | Care already delivered to one or a few identifiable patients | Written consent from the patient, or next of kin where the patient has died or lacks capacity | The patient, on a form you retain | Yes — consent comes from the patient, not a committee | Cannot be published while the patient remains identifiable; no institution can waive publication consent on a patient's behalf |
| Service audit or QI project | Care measured against an existing standard, with no research intervention | Audit or clinical governance registration; a committee statement that review was not required is stronger | The audit or governance office, plus a committee opinion where reachable | Yes, though registration ideally precedes the work | An editor has to judge audit against unapproved research, and an unclear case invites a query |
Route one: apply to a registered ethics committee that accepts applicants from outside its own institution
A committee need not sit inside your hospital. Committees at teaching hospitals, medical colleges and universities, and independent committees registered with a national authority, may accept external investigators, sometimes for a fee. Ask your national registry for the regional list where one is published, approach a nearby teaching hospital's research office, or ask a co-author whose institution has a committee to route the protocol through theirs.
Apply with the protocol you actually followed. If the data are already collected, say so on the form — a committee that discovers this afterwards may withdraw its decision.
Route two: ask your head of institution to constitute a committee or refer the study — an institutional letter is not ethics approval
An institutional letter is not ethics approval. A medical superintendent, dean, medical director or head of department cannot approve human research and cannot grant a waiver of consent. Under the ICMR National Ethical Guidelines and their equivalents elsewhere, a waiver for retrospective record review is granted by a registered ethics committee. No administrative signature substitutes for one, however senior.
What the head of institution can do is constitute a registered committee, or refer your study to one that exists. Send whichever variant applies.
Variant A — asking the institution to constitute a committee
Dear [Name, Medical Director / Head of Institution],
I am writing to request that the institution constitute an Institutional Ethics Committee and register it with [the applicable national authority, or: an authority I have not been able to identify for our country, on which I would welcome guidance].
I have completed [brief description — for example, a retrospective review of the records of 120 patients treated between March 2023 and February 2024]. Journals following the Declaration of Helsinki and the COPE Core Practices require approval or a formally documented waiver issued by a research ethics committee, and neither can come from an administrative office. Without a constituted committee, work carried out here cannot be submitted in the usual way, and that applies to every future study from this institution, not only to mine.
Composition is set by the applicable national authority and should be confirmed against its current rules. In India, for example, the ICMR National Ethical Guidelines and the New Drugs and Clinical Trials Rules 2019 require at least seven members, including a chairperson from outside the institution, a member secretary, basic medical scientists, clinicians, a legal expert, an ethicist or social scientist and a lay member, together with written standard operating procedures and registration with the national registry.
I would be glad to help prepare the application. In the interim, please advise whether this study may be referred to a registered external committee.
Yours sincerely, [name, designation, department, date]
Variant B — asking the institution to refer the study to a named external committee
Dear [Name, Medical Director / Head of Institution],
I am writing to request that the institution formally refer the study below to [name of registered external ethics committee], which accepts applications from investigators outside its own institution.
Study title: [title as it will appear on the manuscript]. Design: [retrospective record review / case series / service audit]. Data source: [department, hospital]. Data-collection window: [start date] to [end date]. The study [does / does not] involve identifiable patient information.
The referral needs to state that the institution holds the records, consents to their use for this study, and has no constituted ethics committee of its own. The committee will then issue its own decision.
So that the decision is usable, please ensure the returned document carries committee letterhead, the committee's registered name and registration number, the protocol title as submitted, the decision date, the scope of what was approved or waived, and the signature of the chair or member secretary.
The protocol and data-collection form are attached, and I am happy to present the study if required.
Yours sincerely, [name, designation, department, date]
Route three: report accurately that no committee existed and describe precisely what oversight did occur
Where no committee can be reached and the study could not have exposed anyone to prospective risk — a record review, an audit — the remaining route is disclosure. This is not a third way of getting approved. It is a reporting obligation.
State in the Methods that no constituted committee existed during the study period, what oversight did occur and who provided it, how confidentiality was protected, and that the work followed the principles of the Declaration of Helsinki. An editor may still decline on that basis — a legitimate outcome, and a better one than a fabricated approval number surfacing years later. See writing the methods for a retrospective chart review.
A single case report needs the patient's consent, not committee review — a different document entirely
A case report describes care already delivered rather than a research intervention, and many committees decline to review one. What you need is written consent from the patient for publication of the case and any images, on a form you keep and can produce on request. Where the patient has died or lacks capacity, consent comes from the next of kin or legal representative.
Where neither can be traced, say so, and expect assessment of whether the patient is still identifiable — removing a name does not anonymise a rare presentation reported alongside a date and a named hospital. See patient consent for case reports and clinical photographs.
What a usable approval or waiver letter must physically contain before you rely on it
Check the document the day it arrives. It must carry:
- Institutional or committee letterhead
- The full name of the committee, as registered
- Its national registration number, where a registry operates in your country
- The protocol title, matching the title you submitted
- The date of the decision, sitting in a sensible relation to your data-collection window
- The scope — approval, exemption, or waiver of consent, and for exactly which study
- A reference or approval number, where the committee issues one
- The name and signature of the chair or member secretary
A decision dated after enrolment closed on a prospective interventional study confirms the problem. If the title does not match, ask for the letter to be reissued before you submit.
Three model Methods sentences, including the one that states the absence plainly
Use whichever matches the documents you actually hold, not the one that reads best.
1. Approval from a registered external committee. "The study protocol was reviewed and approved by the [full committee name], [institution], [city, country] (registration number [xxx]; approval reference [xxx], dated [date]), which accepts applications from investigators at institutions without a constituted ethics committee. [Your institution] has no constituted ethics committee, and the study was referred to that committee by the head of institution."
An editor can check this against the letter itself, and against the registry entry where one is public.
2. A documented committee-granted waiver for record-based research. "This retrospective study of existing medical records was reviewed by the [full committee name] (registration number [xxx]), which approved the study and granted a waiver of individual informed consent for the use of de-identified, routinely collected data (reference [xxx], dated [date]). All records were anonymised before analysis, and no identifiable information is reported."
An editor will look for the committee's own decision, described as such; a sentence saying the department head waived consent describes a different, unusable document.
3. Stating the absence plainly. "At the time this study was conducted, [institution] had no constituted institutional ethics committee, and no registered committee was reachable to the authors. The study was a retrospective review of records generated during routine clinical care, with no intervention and no change to patient management. It was conducted in accordance with the principles of the Declaration of Helsinki. Permission to access the records was granted in writing by [role, for example the Medical Superintendent] on [date]; this constitutes institutional permission and not ethical approval. All data were anonymised at extraction, and no patient-identifiable information appears in this report."
An editor reading that knows exactly what did and did not happen, and can decide on the record. Nobody can tell you in advance what that decision will be, and any journal offering a form of words guaranteed to pass is not describing ethical review. Explain the position in your cover letter to the editor.
Inventing a committee name or an approval number is the one move that ends a career
The temptation arrives at the moment described at the top: a mandatory field, a finished manuscript, no document. Typing an invented committee name or a plausible reference number into that field is research misconduct — fabrication of a research record — and it sits in a different category from every other problem here.
It is also detectable. Registration numbers can be checked against public registries where a registry is published, committees can be asked whether a reference is theirs, and decision dates can be compared with enrolment windows. Detection can come long after publication, and it can come from a reader rather than from the journal; where the finding is upheld, the result is a retraction notice that stays attached to the paper permanently. Every honest route above leaves you with a paper that may be declined; fabrication leaves you with one that may be retracted.
Our editorial policies align with the COPE Core Practices, and the requirements that apply to your submission are set out in Publication Ethics, Research Integrity and the Author Guidelines. See also our guides to reporting ethics approval and informed consent, patient consent for case reports, and what the corresponding author is responsible for — because whoever signs the ethics declaration answers for it.