Overview
Ethics applications are often returned for reasons that have little to do with the research itself: the information sheet says data will be anonymous while the protocol describes audio recordings; the consent form is written at a reading level far above the participants'; recruitment through a manager creates pressure the application does not address; or data storage is described vaguely. Each round of revisions can cost weeks.
We work from your protocol and your institution's forms, whether that is a US Institutional Review Board (IRB) under the Common Rule, a UK or European research ethics committee (REC), an NHS or health authority process, or a national committee elsewhere. We check that every section tells the same story, that risks are identified and matched with realistic mitigations, and that consent documents meet the required elements in plain language.
You remain the applicant. We prepare and review documents with you, but you submit through your institution's system, answer to the committee and take responsibility for the study's ethical conduct. We do not determine whether your study is exempt; that decision belongs to your IRB or committee, and we help you present the information it needs to decide.
Who it’s for and the problems it solves
This is for you if you are…
- Students preparing a first ethics application for a dissertation or thesis
- Researchers whose application was returned with conditions or a request for major revisions
- Researchers working with children, patients, refugees, employees or other groups needing extra safeguards
- Teams running multi-site or international studies that need approval from more than one committee
- Early-career researchers preparing amendments after changes to their protocol
Common problems we help with
- You do not know which review category your study falls into or what the form expects in each section
- Your consent form and information sheet are long, technical and inconsistent with the protocol
- The committee asked how you will handle distress, disclosure of harm or power imbalance, and you are unsure how to respond
- You plan online data collection or recordings and need to explain data security convincingly
- Your study involves a vulnerable group and you need appropriate assent, gatekeeper or capacity procedures
- You received conditional approval and need a clear, point-by-point response
What’s included — and what isn’t
Included
- Review of your protocol and institution's forms, with a checklist of every required document
- Help describing the study design, procedures, recruitment and participant burden clearly and consistently
- Risk and benefit assessment covering physical, psychological, social, legal and data-related risks, with mitigations
- Participant information sheets (PIS) and informed consent forms, including the key information summary many IRBs require
- Age-appropriate assent forms, parent or guardian consent and gatekeeper letters
- Procedures for vulnerable groups: capacity, dependency relationships, cultural and language considerations
- Distress, safeguarding and incidental disclosure protocols
- Data protection sections aligned with your data management plan: storage, access, retention, anonymization or pseudonymization
- Recruitment materials, debriefing sheets and withdrawal procedures
- Point-by-point response letters to committee conditions and amendment requests
Not included
- Submitting the application, signing declarations or corresponding with the committee on your behalf
- Deciding exemption status or guaranteeing approval; only your committee or IRB can decide
- Legal advice on data protection, clinical trial regulations or local law; your institution's research governance or legal office is the authority
- Describing safeguards in the application that you will not actually implement
What you receive
- Document checklist and gap review
- A list of everything your committee requires, with notes on inconsistencies or missing information in your current drafts.
- Edited application form
- Tracked-change revisions and comments on your form, focused on clarity, consistency and the points committees commonly query.
- Participant-facing documents
- Information sheet, consent and assent forms, recruitment text and debrief sheet written in plain language and checked against your protocol.
- Risk and safeguarding protocol
- A table of foreseeable risks, likelihood, mitigations and responsible persons, plus distress or disclosure procedures where relevant.
- Response to committee
- When needed, a point-by-point response letter and revised documents addressing each condition.
How it works
Gather requirements
You share your protocol, institution's forms, templates and any guidance. We confirm the review route you expect and the full list of documents.
Consistency and risk review
We read everything together, map where descriptions conflict and identify risks that need clearer mitigation.
Draft and revise documents
We prepare or revise the application sections and participant materials with you, keeping your institution's templates where they are mandatory.
Final check
We run a last cross-check of dates, versions, contact details and data statements before you submit.
Committee response
If the committee requests changes, we help you prepare a clear response and revised documents for resubmission.
Frameworks and review routes we work with
- US IRB and the Common Rule
- Applications framed around the revised Common Rule (45 CFR 46), including the concise key information section at the start of consent documents and the exempt, expedited and full-board routes your IRB determines.
- UK and European research ethics committees
- University REC forms and, for health research, national approval systems, with attention to participant information sheets and data protection transparency requirements.
- Core ethical principles
- Respect for persons, beneficence and justice from the Belmont Report, and the principles of the Declaration of Helsinki for health research.
- Discipline codes
- Guidance from bodies such as the APA, BPS, BERA or ESRC where your field expects it to be cited.
- Informed consent design
- Plain-language summaries, layered information, readability checks, verbal and online consent procedures, and consent for recording and data sharing.
- Vulnerable groups
- Children and young people, people who may lack capacity, patients, prisoners, refugees and employees recruited by their employers, with proportionate additional safeguards.
Why applications come back, and how to prevent it
Committees are not trying to stop research; they are checking that participants are protected and that the researcher has thought through what could go wrong. The most frequent issues we see are avoidable.
- Promising 'anonymity' when the researcher will know who participants are; 'confidentiality' is usually the accurate term
- Inconsistent numbers, durations or procedures between the form, protocol and information sheet
- Recruitment that creates pressure, such as a teacher recruiting their own students or a manager recruiting staff
- No plan for what happens if a participant becomes distressed or discloses risk of harm
- Vague data storage ('on a secure computer') without location, access, encryption and retention period
- Consent forms written for academics rather than for the actual participants
Consent documents participants can understand
Informed consent is a process, not a signature. The information sheet should explain, in everyday language, why the study is being done, what taking part involves, the risks and benefits, how data will be used and kept, and that participants may withdraw, including any limits on withdrawing data once it is anonymized or analyzed.
We draft to the reading level of your participants, use short sections with clear headings, and put the most important information first, which reflects the revised Common Rule's key information requirement and good practice elsewhere. For online surveys we adapt consent into a first-page format with an explicit agreement step.
Research with vulnerable groups
Some participants face greater risk or reduced ability to consent freely. Children usually need parental consent and their own age-appropriate assent. Adults who may lack capacity need procedures consistent with the relevant law and committee. Refugees, patients and employees may feel unable to refuse. We help you describe proportionate safeguards, such as independent recruitment routes, trained interpreters, consultee or advocate involvement and clear referral pathways, without making the study unworkable.
Aligning ethics with data protection
Your ethics application and your data management plan must say the same thing about what is collected, where it is stored, who can access it and when it is deleted. Where GDPR or similar law applies, the information sheet also serves as a transparency notice. Our data management plan service can prepare the two together.
What the work can look like
Illustrative example — fictional data
A student study interviewing nurses about moral distress
A fictional master's student plans 12 interviews with nurses at the hospital where the student also works part time. The first application was returned with conditions about recruitment, distress and data storage.
Recruitment and power
Recruitment was moved from direct invitations by the student to a neutral email from the nursing research office, with interested nurses contacting the student directly. The application now states that the student will not interview anyone they supervise or work alongside.
Distress protocol
A three-step protocol was added: pause and check in, offer to stop or skip, and provide details of the employee assistance program and a professional support line. The information sheet explains this in two sentences.
Data statements
'Stored securely' was replaced with the university's encrypted cloud storage, access limited to the student and supervisor, pseudonymized transcripts and deletion of audio after transcription checking. The response letter addressed each condition in a numbered table.
Illustrative, invented scenario. Requirements differ by institution, country and type of research.
What you’ll need to provide
- Your research protocol or proposal, including instruments such as questionnaires and interview guides
- Your institution's application forms, templates and ethics guidance
- Details of participants, recruitment routes, sites and any gatekeepers
- Your data management plan or data storage arrangements
- Any previous committee feedback or conditions
You don’t need everything ready to ask for a quote — tell us what you have and we’ll say what’s missing.
What affects price and turnaround
Price depends on
- Number and complexity of documents required by your committee
- Whether participants include vulnerable groups needing additional forms and procedures
- Number of sites, committees or languages involved
- Whether you need a full preparation or a review of drafts you have written
- Responding to committee conditions or amendments
Turnaround depends on
- Committee submission deadlines and meeting dates, which we plan backwards from
- Completeness of your protocol and instruments at the start
- Speed of supervisor or principal investigator sign-off
Every project is quoted individually. How we price our work.
Questions people ask before starting
Can you tell me whether my study is exempt?
We can explain how categories such as exempt, expedited or minimal risk are usually described, and help you present your study so the reviewer has what they need. Only your IRB or committee can make the determination, and many institutions do not allow researchers to self-certify exemption.
Will you submit the application for me?
No. You or your principal investigator submit it through your institution's system and remain the named applicant. We prepare and check the documents with you.
Will my application definitely be approved?
That decision rests with the committee alone. We reduce avoidable problems such as inconsistencies and unclear safeguards, which often shortens the review, but committees make independent decisions and may ask for changes to the study itself.
My institution has its own consent template. Do you replace it?
No. Mandatory templates are kept, and we fill them clearly and consistently. Where a template allows adaptation, we improve readability within the required structure.
Do I need ethics approval for analyzing public or secondary data?
Often not, but it depends on your institution and the data. Some committees require a short application or confirmation even for anonymized secondary data. Check with your committee; we can help you prepare the request.
Can you help with an amendment after approval?
Yes. Changes such as new sites, instruments or recruitment routes usually need an amendment before they are implemented. We help you describe the change, its implications and revised documents.
Is this acceptable help for a student project?
Supervisors routinely help students with ethics applications, and editorial and methodological support is similar. You make the decisions and sign the declarations, and you should check your program's guidance on external help.