03 · What You Need to Know
Supporting documents are evidence of what the application describes
The application form summarizes and explains the proposed study. Supporting documents let reviewers examine the materials and procedures behind that explanation.
For example, an application may state that participants will receive clear information before consenting. The participant information sheet shows what they will actually be told. The application may state that interview questions are not unusually sensitive. The interview guide allows reviewers to evaluate that claim. The application may describe recruitment as neutral and noncoercive. The advertisement or recruitment email shows the language prospective participants will actually encounter.
This is why attachments should not be treated as administrative extras. They are often part of the evidence the committee uses to decide whether the study is ethically acceptable.
The research protocol usually provides the complete study description
A protocol typically describes the rationale, objectives, study design, population, procedures, data collection, analysis, ethical considerations, and other operational details of the research.
WHO's recommended protocol format, for example, covers the study rationale and objectives, design, methodology, safety considerations, follow-up, data management and statistical analysis, project management, ethical considerations, informed consent, funding, investigator information, and other relevant matters.
What your own protocol must contain depends on the committee and research type. Some institutions provide mandatory templates, while others accept an existing protocol or research proposal if it contains the required information.
The protocol and application should describe the same study. If one says you will conduct one interview and the other says two, the submission package now contains an unresolved methodological question.
Participant information and consent materials show what people will be told
Where informed consent is required, committees commonly review the participant-facing information and consent documentation used in the process.
These documents may explain the study's purpose, procedures, duration, risks, potential benefits, voluntariness, confidentiality, compensation, withdrawal, contacts, and other information required by the applicable framework.
WHO's protocol guidance, for example, requires informed consent forms with the approved protocol for research within its review system and notes that different participant groups may require separately tailored forms. OHRP guidance likewise identifies a proposed informed consent document among materials used for initial review of research under the relevant U.S. regulations.
Studies involving different populations or procedures may therefore require more than one consent document. Whether every version of a participant information sheet or consent form requires approval depends on the applicable review process, but version control is important whenever multiple documents exist.
Assent and parental or guardian permission may be needed for some participants
Research involving children or other circumstances in which someone other than the participant may provide legally effective permission can require additional documents.
These might include age-appropriate assent materials and parental or guardian permission documents, depending on the population and applicable legal and ethical framework.
Do not simply reuse an adult consent form and change the title. Participant-facing materials should be appropriate to the people receiving them and to the decisions they are being asked to make.
Recruitment materials may be part of the ethics review
Recruitment is often the participant's first contact with the study, so the wording used there can affect voluntariness and expectations before formal consent begins.
Relevant materials may include posters, flyers, emails, letters, scripts, online advertisements, website text, messages sent through organizations, and other invitations. Under OHRP guidance for research subject to the relevant U.S. regulations, initial review materials include recruitment materials, including advertisements intended to be seen or heard by prospective participants.
Your committee may have different requirements, but you should not assume recruitment sits outside ethics review. Check whether your recruitment materials need approval before use.
Social media recruitment can create additional materials to submit
A social media post may function as a recruitment advertisement even when it looks informal. The text, images, eligibility claims, benefit statements, compensation language, links, and mechanism for contacting the research team may all affect what prospective participants understand.
Some studies also use multiple versions for different platforms. If so, determine whether the committee expects each version, a template, screenshots, or another form of documentation.
Do not assume that approval of a general recruitment plan automatically authorizes any future post you decide to publish. Check the rules governing social media recruitment materials before posting them.
Questionnaires, interview guides, and other instruments may need review
Study instruments can reveal ethical issues that a protocol summary cannot.
A questionnaire may contain sensitive questions. An interview guide may invite disclosure about illegal behavior, trauma, workplace misconduct, or identifiable third parties. Experimental stimuli may involve deception or disturbing content. An observation form may collect information participants did not expect to disclose.
WHO's recommended protocol format explicitly states that instruments used to collect information, including questionnaires, focus-group guides, observation forms, and case-report forms, should be provided within its protocol framework.
Requirements elsewhere vary. Verify whether your research instruments need ethics approval and whether the committee expects final versions at initial submission.
Study-specific safety documents may be necessary
Interventional, clinical, or otherwise higher-risk research may require documents that would make little sense for a routine interview study.
Depending on the research and governing framework, supporting materials might include an investigator brochure, product or device information, safety-monitoring arrangements, adverse-event procedures, stopping rules, laboratory information, insurance or indemnity documentation, or other technical materials.
OHRP guidance for U.S. IRBs, for example, identifies an investigator brochure among initial-review materials when one exists. WHO's protocol guidance also expects relevant safety information and, for randomized controlled trials, details such as stopping rules and procedures for breaking codes.
The principle is study-specificity. Do not search for an imaginary universal attachment checklist and submit irrelevant documents merely because another kind of research requires them.
Funding and sponsor documents may be relevant
Committees may need information about who funds or sponsors the research, particularly when funding arrangements affect responsibilities, conflicts of interest, insurance, access to data, publication, or other aspects of participant protection.
OHRP guidance identifies relevant grant applications among initial-review materials for research within its scope. WHO's recommended protocol format also includes sponsor or funder information, project financing, and other support.
Whether you need to attach a complete grant application, funding agreement, budget, or sponsor document depends on the committee's requirements and the study.
Investigator qualifications may need documentation
Some committees require curriculum vitae, research-ethics training certificates, professional credentials, declarations, or other evidence that investigators are appropriately qualified to conduct the proposed procedures.
WHO's recommended protocol format, for example, calls for CVs of the principal investigator and co-investigators within its framework.
This requirement is particularly understandable when a study involves procedures requiring specialized competence. A protocol may describe a procedure as safe when performed appropriately, but the committee may also need assurance that the people performing it are appropriately prepared.
Permissions and site approvals can be separate from ethics approval
A researcher may need permission to recruit or collect data at a school, hospital, company, community organization, archive, or other site. Depending on local procedures, the ethics committee may ask for a letter of cooperation, site authorization, data-access permission, or another document demonstrating that the relevant organization permits the proposed activity.
Do not assume, however, that institutional permission and ethics approval are interchangeable. Permission from a site does not necessarily constitute ethics approval, and ethics approval does not necessarily give you an independent legal or organizational right to access a site, records, or participants.
Ethics approval
The relevant ethics body has made the required determination about the ethical acceptability of the proposed research under its framework.
Site or organizational permission
The relevant organization authorizes research activities, access, recruitment, data use, or another activity within its authority.
Translations may need to accompany participant-facing documents
If participants will receive information, recruitment materials, or consent documents in more than one language, the committee may require translated versions and may specify when translations should be submitted.
Procedures differ. WHO's own protocol guidance, for example, notes that translations of informed consent materials may be completed after the English-language version has been approved by its Research Ethics Review Committee. That is a WHO-specific procedure, not a universal sequence.
Follow your committee's instructions rather than translating at a particular stage merely because another institution does so.
Data-related documentation may be required when information handling is complex
Some studies require more than a paragraph about secure storage. Research involving data sharing, linkage of multiple datasets, identifiable records, biological materials, international transfer, external processors, repositories, or future secondary use may require additional documentation.
Depending on the institution and applicable law, this could include a data-management plan, data-sharing agreement, privacy documentation, repository information, or another institutional form.
These requirements are especially variable because ethics review may intersect with privacy law, information-security policy, contractual restrictions, and institutional governance.
The documents must agree with one another
A complete submission can still be defective if its documents describe different studies.
Watch Out
Check names, sample sizes, eligibility criteria, procedure duration, compensation, risks, potential benefits, withdrawal arrangements, data retention, contact details, and document version numbers across the entire submission. A contradiction between attachments can be more consequential than a missing sentence.
This is one reason a clear ethics application should describe what the study will actually do. Every supporting document should implement that same study rather than quietly introducing another version of it.
