# Research Ethics Application: [Short study title]

> Application template for review of research involving human
> participants, their data or their biological samples by an
> institutional review board (IRB) or research ethics committee (REC).
> It is organised around the principles of the WMA Declaration of
> Helsinki (2024 revision, 37 paragraphs) and shows dated examples of the
> rules in the EU, UK and US. Your committee's own form always takes
> precedence: copy these answers into it. This is a documentation format,
> not legal, medical or ethical advice; check the current official texts
> and consult your IRB/REC office and a qualified professional. Replace
> every `[bracketed]` value and every row marked *Example*.

<!--
Guidance: How to use this template
- Ask your IRB/REC office first which form, system and review route apply.
  Many committees require their own online system (for example IRAS in the
  UK, CTIS for clinical trials of medicines in the EU, or an institutional
  portal in the US). Use this document to draft and agree answers with
  co-investigators, then transfer them.
- Write for a lay member of the committee: plain words, short sentences,
  every abbreviation defined.
- The committee judges three things above all: is the research worth
  doing, are risks minimised and reasonable against benefits, and is
  consent (or its waiver) properly handled. Make those answers easy to
  find.
- Keep the protocol, consent documents and data management plan
  consistent with this application; reviewers compare them line by line.
- The worked example (a fictional interview study with family carers of
  people on home dialysis at the fictional Fenmoor University and Fenmoor
  Health District) is minimal-risk social research. Clinical trials of
  medicines or devices need extra regulatory sections; see section 12.
-->

## Document control

<!-- Guidance: Track the application as a controlled document. Committees often ask for version numbers and dates on every attachment. -->

| Field | Value |
|---|---|
| Document ID | [REA-001] |
| Committee | [Name of IRB / REC] |
| Committee reference | [Assigned on submission] |
| Review route requested | [Exempt / Expedited or proportionate / Full committee] |
| Study type | [Interview / Survey / Observational / Clinical trial / Secondary data / Biobank] |
| Sponsor | [Organisation that takes on sponsor responsibilities] |
| Funder | [Funder and grant number] |
| Version | [0.1] |
| Status | [Draft / Submitted / Conditions / Approved / Amended] |
| Owner | [@chief-investigator] |
| Approvers / reviewers | [@sponsor-representative], [@data-protection-officer], [@head-of-department] |
| Last updated | YYYY-MM-DD |
| Classification | [Internal until approval] |

### Approvals

| Role | Name | Decision | Date |
|---|---|---|---|
| Chief investigator | [@name] | [Signed] | YYYY-MM-DD |
| Sponsor representative | [@name] | [Sponsorship confirmed] | YYYY-MM-DD |
| Data protection officer | [@name] | [Reviewed] | YYYY-MM-DD |
| Scientific or peer reviewer | [@name] | [Reviewed] | YYYY-MM-DD |

## Revision history

<!-- Guidance: Record the submitted version, every response to committee conditions, and every later amendment with its approval date. -->

| Version | Date | Author | Change summary |
|---|---|---|---|
| 0.1 | YYYY-MM-DD | [@name] | First draft |
| 1.0 | YYYY-MM-DD | [@name] | Submitted to committee |
| 1.1 | YYYY-MM-DD | [@name] | *Example:* Response to conditions: added distress protocol and revised consent form wording |
| 2.0 | YYYY-MM-DD | [@name] | *Example:* Substantial amendment: added focus group |

## Contents

<!-- Guidance: Keep in sync with the headings below. -->

1. [Study summary](#1-study-summary)
2. [Research team and sponsorship](#2-research-team-and-sponsorship)
3. [Scientific justification and design](#3-scientific-justification-and-design)
4. [Participants and recruitment](#4-participants-and-recruitment)
5. [Risks, burdens and benefits](#5-risks-burdens-and-benefits)
6. [Informed consent](#6-informed-consent)
7. [Privacy, confidentiality and data protection](#7-privacy-confidentiality-and-data-protection)
8. [Payments, compensation and insurance](#8-payments-compensation-and-insurance)
9. [Conflicts of interest](#9-conflicts-of-interest)
10. [Safety, monitoring and incidents](#10-safety-monitoring-and-incidents)
11. [Registration, dissemination and after the study](#11-registration-dissemination-and-after-the-study)
12. [Review route and regulatory context](#12-review-route-and-regulatory-context)
13. [Declarations and attachments](#13-declarations-and-attachments)
14. [Declaration of Helsinki map](#14-declaration-of-helsinki-map)
15. [Glossary and references](#15-glossary-and-references)

## 1. Study summary

<!-- Guidance: Most committees read this first. In about 250 words of plain language, say what you want to find out, why, who takes part, what they will do, and the main risks. -->

The summary lets every committee member, including lay members,
understand the study before reading the detail.

| Field | Content |
|---|---|
| Full title | *Example:* Living with a machine at home: an interview study of family carers of people on home haemodialysis |
| Lay title | *Example:* What is it like to care for someone on dialysis at home? |
| Research question | *Example:* How do family carers experience the daily work of home haemodialysis, and what support is missing? |
| Participants | *Example:* About 18 to 20 adult family carers |
| What participants do | *Example:* One interview of up to 90 minutes, or one focus group of up to 2 hours |
| Main risks | *Example:* Emotional distress when talking about caring; loss of confidentiality |
| Expected duration | *Example:* 12 months from approval |
| Sites | *Example:* Home dialysis service, Fenmoor Health District |

**Lay summary:** [Plain-language summary of about 250 words.]

## 2. Research team and sponsorship

<!-- Guidance: Show that the team is qualified for the work (Declaration of Helsinki para 12 asks that research be done by people with appropriate ethics and scientific education, training and qualifications). Name a sponsor where your jurisdiction requires one. -->

| Role | Name | Organisation | Qualifications and relevant experience |
|---|---|---|---|
| Chief investigator | [@name] | [Organisation] | *Example:* Nurse researcher, PhD, 6 years of qualitative interview experience, current research ethics and GCP training |
| Co-investigator | [@name] | [Organisation] | [Experience] |
| Student researcher | [@name] | [Organisation] | [Programme and supervisor] |
| Patient and public partner | [@name] | [Organisation] | *Example:* Former carer, reviewed study materials |

| Field | Content |
|---|---|
| Sponsor | *Example:* Fenmoor University Research Governance Office |
| Sponsor contact | [Name, role, contact route] |
| Peer review of the science | *Example:* Independent review by the school research committee, YYYY-MM-DD |

## 3. Scientific justification and design

<!-- Guidance: A study that cannot answer its question exposes people to burden for nothing, so committees review scientific validity. Summarise the protocol; do not paste it. -->

Explain why the research is needed and how its design will answer the
question.

### 3.1 Background and justification

[What is known, the gap, and why the study is needed now. Cite a
literature review where possible.]

### 3.2 Design and methods

| Element | Content |
|---|---|
| Design | *Example:* Qualitative, semi-structured interviews and one focus group, reflexive thematic analysis |
| Procedures for participants | *Example:* Consent visit or call, then interview at home, by video or at the university |
| Sample size and justification | *Example:* 18 to 20 carers, judged by information power |
| Analysis | *Example:* Coding by two researchers with qualitative software |
| Duration of participation | *Example:* One session; optional review of a summary of findings |
| Protocol | [Attachment reference and version] |

See `science/qualitative-study-report` for how the findings will be
reported, or `science/trial-protocol` for an interventional study.

## 4. Participants and recruitment

<!-- Guidance: Describe who is eligible and who is not, how people will be identified and approached, and why the approach is free of pressure. Groups that are left out of research without reason also raise fairness questions. -->

This section shows that selection is fair and that people can decline
freely.

### 4.1 Eligibility

| Criterion | Detail | Justification |
|---|---|---|
| Inclusion | *Example:* Adult (18 or over) who is the main unpaid carer of a person on home haemodialysis for at least 3 months | Experience needed to answer the question |
| Exclusion | *Example:* Carers who are also staff of the dialysis service | Avoids a dual role and pressure |
| Language | *Example:* Interpreters available for the three most common community languages | Avoids excluding carers who need an interpreter |

### 4.2 Identification and approach

| Step | Who does it | What happens |
|---|---|---|
| 1 | *Example:* Dialysis nurse (direct care team) | Hands out an invitation pack; does not record who accepts |
| 2 | *Example:* Carer | Contacts the research team if interested |
| 3 | *Example:* Researcher | Sends the information sheet; allows at least 48 hours before the consent conversation |

```mermaid
flowchart TD
  A["Care team gives invitation pack"] --> B{"Carer contacts researcher?"}
  B -- "No" --> C["No further contact"]
  B -- "Yes" --> D["Information sheet sent"]
  D --> E["At least 48 hours to consider"]
  E --> F{"Consent given?"}
  F -- "No" --> C
  F -- "Yes" --> G["Interview or focus group"]
```

### 4.3 Vulnerability and power relationships

<!-- Guidance: Declaration of Helsinki paras 19 and 20 address individual, group and community vulnerability. Explain who may be vulnerable in your study and the specific protections you add. -->

| Group or factor | Why it matters | Protection |
|---|---|---|
| *Example:* Carers under strain | Talking about caring can be upsetting | Distress protocol, breaks, right to stop |
| *Example:* Dependence on the dialysis service | Fear that declining could affect the patient's care | Care team never knows who took part; statement in the information sheet |
| [Children / people lacking capacity / prisoners / students or employees of the team] | [Reason] | [Protection; extra rules may apply] |

## 5. Risks, burdens and benefits

<!-- Guidance: Declaration of Helsinki paras 16 to 18. List every foreseeable risk and burden, how likely and serious it is, and how you minimise and monitor it. Then state benefits honestly, without overstating them. -->

| ID | Risk or burden | Likelihood | Severity | Minimisation |
|---|---|---|---|---|
| RSK-01 *(Example)* | Emotional distress during interview | Possible | Low to moderate | Distress protocol; signposting to support services |
| RSK-02 *(Example)* | Disclosure of identity in reports | Unlikely | Moderate | Pseudonyms; removal of rare details; quotations checked |
| RSK-03 *(Example)* | Time taken (up to 2 hours) | Certain | Low | Flexible times; video option; reimbursement of costs |
| RSK-04 *(Example)* | Disclosure of risk of harm to the patient or carer | Rare | High | Safeguarding procedure explained before consent (section 10) |
| RSK-05 [ID] | [Risk] | [Likelihood] | [Severity] | [Minimisation] |

| Benefits | Content |
|---|---|
| To participants | *Example:* None directly expected; some carers value being heard |
| To others | *Example:* Evidence to design carer support in home dialysis services |

**Risk-benefit judgement:** [Explain why the remaining risks are
reasonable in relation to the importance of the question.]

## 6. Informed consent

<!-- Guidance: Declaration of Helsinki paras 25 to 32. Describe who obtains consent, when, how understanding is checked, how withdrawal works, and how consent is recorded. If you ask for a waiver, address each legal criterion that applies in your jurisdiction. -->

This section explains how people decide freely and with enough
information.

| Field | Content |
|---|---|
| Who obtains consent | *Example:* The chief investigator, trained in consent |
| When | *Example:* At least 48 hours after receiving the information sheet |
| Format | *Example:* Written or electronic signature; recorded verbal consent for video interviews |
| Checking understanding | *Example:* Teach-back questions on purpose, risks and withdrawal |
| Withdrawal | *Example:* Any time without reason; interview data can be withdrawn until analysis starts on YYYY-MM-DD |
| Capacity | [How capacity is assessed, and the legal route if adults lacking capacity are included] |
| Children | [Parental permission and child assent process, if applicable] |
| Future use of data | [Broad or specific consent for future research, if requested] |
| Documents | [Information sheet and consent form, versions and dates]; see `science/informed-consent-form` |

**Waiver or alteration of consent (if requested):** state which rule you
rely on and address each condition. *Example (US Common Rule):* 45 CFR
46.116(f)(3) lets an IRB waive or alter consent only if the research
involves no more than minimal risk, could not practicably be carried out
without the waiver, could not practicably use non-identifiable data where
identifiable data are used, would not adversely affect participants'
rights and welfare, and gives pertinent information afterwards when
appropriate. Other jurisdictions use different tests; check the current
text with your committee.

## 7. Privacy, confidentiality and data protection

<!-- Guidance: Declaration of Helsinki para 24. Describe what data you collect, the legal basis, where it is stored, who can see it, how long it is kept and how it is destroyed or archived. Agree this section with your data protection officer. -->

| Field | Content |
|---|---|
| Personal data collected | *Example:* Name and contact details (consent and scheduling only); audio recordings; transcripts; age band, relationship to patient |
| Special category or sensitive data | *Example:* Health information about the patient as mentioned by the carer |
| De-identification | *Example:* Pseudonymised transcripts, key stored separately |
| Storage and access | *Example:* University secure research store, access limited to named researchers |
| Transfers outside the organisation | *Example:* Transcription company under a confidentiality and data processing agreement |
| Retention | *Example:* Consent forms 10 years per sponsor policy; audio deleted after transcript check |
| Sharing | *Example:* Interview guide and codebook only; transcripts not shared |
| Data management plan | [Attachment]; see `science/data-management-plan` |

Dated examples of rules that may apply (check the current text and your
data protection officer):

| Jurisdiction | Example rule, as checked in October 2026 |
|---|---|
| EU | General Data Protection Regulation (EU) 2016/679: Article 9(2)(j) on processing special category data for scientific research, with Article 89(1) safeguards, plus member state law |
| UK | UK GDPR and the Data Protection Act 2018, with HRA guidance on data protection in health research |
| US | HIPAA Privacy Rule 45 CFR 164.512(i) on uses and disclosures for research (for covered entities), plus state law |

## 8. Payments, compensation and insurance

<!-- Guidance: Declaration of Helsinki para 15 covers compensation and treatment for harm. Committees check that payments do not pressure people into taking part. -->

| Field | Content |
|---|---|
| Expenses | *Example:* Travel costs reimbursed at actual cost |
| Payment for time | *Example:* A gift voucher of the same value for every participant, given even if the participant withdraws |
| Compensation for harm | [Arrangements] |
| Insurance or indemnity | *Example:* University clinical trials and public liability insurance confirmed by the sponsor |

## 9. Conflicts of interest

<!-- Guidance: Disclose financial and non-financial interests of every investigator and the sponsor, and how they are managed. -->

| Person | Interest | Management |
|---|---|---|
| [@name] | *Example:* None | Not applicable |
| [@name] | [Interest] | [Management plan] |

## 10. Safety, monitoring and incidents

<!-- Guidance: Explain what you will do if something goes wrong, who you will tell and how quickly. For interventional studies add adverse event definitions and reporting timelines from the protocol. -->

| Event | Action | Report to | Timing |
|---|---|---|---|
| Participant distress | *Example:* Pause, offer to stop, give support contacts | Chief investigator | Same day |
| Disclosure of risk of serious harm | *Example:* Follow the safeguarding procedure explained in the information sheet | Safeguarding lead | Same day |
| Data breach | *Example:* Contain and report | Data protection officer | Without delay; legal deadlines may apply |
| Deviation from approved protocol | [Action] | Sponsor and committee | [Per committee rules] |
| Annual or progress report | [Content] | Committee | [Per committee rules] |

For trials, describe the data monitoring arrangements; see
`science/dsmb-charter`.

## 11. Registration, dissemination and after the study

<!-- Guidance: Declaration of Helsinki paras 34 to 36 cover post-trial provisions, registration before recruitment, and publication of results including negative ones. -->

| Field | Content |
|---|---|
| Registration | [Public registry and number; required for clinical trials before the first participant is recruited] |
| Results to participants | *Example:* Plain-language summary sent to those who ask |
| Publication | *Example:* Open access article and conference presentation; negative or inconclusive findings will also be published |
| Post-study provisions | [For trials, access to beneficial interventions after the study] |
| Community engagement | [How affected communities are informed or involved] |

## 12. Review route and regulatory context

<!-- Guidance: The committee decides the route, but you should say which you think applies and why. These are dated examples to guide questions for your committee, not a full statement of the law. -->

| Jurisdiction | Example framework, as checked in October 2026 | Questions for your office |
|---|---|---|
| US | Common Rule, 45 CFR part 46: exemptions (46.104), expedited review (46.110), criteria for approval (46.111), consent (46.116, 46.117), single IRB for cooperative research (46.114); FDA rules for regulated products | Is the study exempt? Which IRB is the single IRB? |
| UK | HRA Approval and REC review through IRAS; the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (SI 2025/538) came into force on 28 April 2026 for clinical trials of medicines | Does the study need NHS REC review or only university review? |
| EU | Clinical trials of medicines under Regulation (EU) No 536/2014 (applies since 31 January 2022), submitted through CTIS; other research follows national law and institutional committees | Which member states and which national ethics bodies? |
| International | ICH E6(R3) Good Clinical Practice (adopted 6 January 2025); CIOMS International Ethical Guidelines for Health-related Research Involving Humans (2016) | Does the sponsor require GCP training for all staff? |

| Field | Content |
|---|---|
| Route requested | *Example:* Proportionate or expedited review, minimal risk social research |
| Reason | *Example:* No intervention, adult participants with capacity, distress risk managed by protocol |
| Other approvals needed | *Example:* Health district research and development permission; data protection impact assessment |

## 13. Declarations and attachments

<!-- Guidance: List every document with its version and date. Missing or inconsistent attachments are the commonest reason for delay. -->

**Chief investigator declaration:** I confirm that the information in
this application is accurate, that the study will be conducted as
approved, and that I will seek approval before making substantial
changes. Signature: [@name], YYYY-MM-DD.

| Attachment | Version | Date |
|---|---|---|
| Protocol | [v] | YYYY-MM-DD |
| Participant information sheet | [v] | YYYY-MM-DD |
| Consent form | [v] | YYYY-MM-DD |
| Invitation letter and advertisements | [v] | YYYY-MM-DD |
| Interview guide or questionnaires | [v] | YYYY-MM-DD |
| Distress and safeguarding protocol | [v] | YYYY-MM-DD |
| Data management plan | [v] | YYYY-MM-DD |
| Evidence of insurance and sponsorship | [v] | YYYY-MM-DD |
| CVs of investigators | [v] | YYYY-MM-DD |
| Scientific peer review | [v] | YYYY-MM-DD |

## 14. Declaration of Helsinki map

<!-- Guidance: Use this to show the committee where each principle is addressed. Paragraph numbers follow the 2024 revision; topics are paraphrased in original words. -->

| Paragraphs | Topic (paraphrased) | Section here |
|---|---|---|
| 1 and 2 | Preamble and scope | 1 |
| 3 to 15 | General principles, including qualified researchers and compensation for harm | 2, 8 |
| 16 to 18 | Risks, burdens and benefits | 5 |
| 19 and 20 | Individual, group and community vulnerability | 4.3 |
| 21 and 22 | Scientific requirements and protocols | 3 |
| 23 | Research ethics committees | 10, 12 |
| 24 | Privacy and confidentiality | 7 |
| 25 to 32 | Free and informed consent | 6 |
| 33 | Use of placebo | [Protocol, if applicable] |
| 34 | Post-trial provisions | 11 |
| 35 and 36 | Registration, publication and dissemination | 11 |
| 37 | Unproven interventions in clinical practice | Not applicable to research applications |

## 15. Glossary and references

<!-- Guidance: Define every abbreviation for lay committee members. -->

| Term | Meaning |
|---|---|
| IRB | Institutional review board (US term) |
| REC | Research ethics committee (UK and many other countries) |
| Sponsor | Organisation that takes responsibility for initiating, managing and financing (or arranging financing for) a study |
| Minimal risk | Risk no greater than that met in daily life or routine examinations; the exact legal definition varies |
| Waiver of consent | Committee permission to do research without some or all elements of consent |
| GCP | Good Clinical Practice |
| CTIS | Clinical Trials Information System (EU) |
| IRAS | Integrated Research Application System (UK) |

Related templates: `science/informed-consent-form`,
`science/trial-protocol`, `science/data-management-plan`,
`science/dsmb-charter`, `science/qualitative-study-report`,
`science/experiment-protocol`, `academic/grant-proposal`.

## Standard and licence note

Based on the WMA Declaration of Helsinki, *Ethical Principles for Medical
Research Involving Human Participants*, as revised by the 75th WMA General
Assembly, Helsinki, October 2024 (https://www.wma.net/policies-post/wma-declaration-of-helsinki/;
also JAMA 2025;333(1):71, https://doi.org/10.1001/jama.2024.21972).
Jurisdiction examples are based on 45 CFR part 46 and 45 CFR 164.512 (eCFR,
https://www.ecfr.gov), the UK Health Research Authority
(https://www.hra.nhs.uk), Regulation (EU) No 536/2014 (European
Commission, https://health.ec.europa.eu/medicinal-products/clinical-trials_en),
Regulation (EU) 2016/679 (https://eur-lex.europa.eu/eli/reg/2016/679/oj),
ICH E6(R3) (https://www.ich.org) and the CIOMS 2016 guidelines
(https://cioms.ch). All were checked in October 2026; laws and guidance
change, so check the current official texts and your committee's rules.
The text is original and reproduces no wording beyond short legal
references. The worked example is fictional. This is a documentation
format, not legal, medical or ethical advice. Template licence: MIT.