03 · What You Need to Know
Think in terms of decisions the committee must make
Different review systems express their approval criteria differently. As one concrete regulatory example, the U.S. Common Rule requires an Institutional Review Board reviewing covered research to make determinations concerning minimization and reasonableness of risks, equitable participant selection, informed consent, safety monitoring when appropriate, and protections for privacy and confidentiality. OHRP therefore advises investigators to provide enough information for the IRB to apply those criteria.
International guidance takes a similarly substantive approach. The World Medical Association's 2024 Declaration of Helsinki states that protocols for medical research involving human participants should address aims, methods, anticipated benefits, potential risks and burdens, researcher qualifications, funding and potential conflicts of interest, privacy and confidentiality, incentives, and other relevant ethical matters.
These frameworks are not interchangeable, and neither should be treated as the universal application form. They illustrate a broader principle: an ethics committee needs evidence on which to base its judgments.
Why is the study being done, and can its design answer the question?
Reviewers first need to understand the purpose of the research. A clear research question or objective allows them to evaluate why participants are being asked to undergo the proposed procedures.
The design matters ethically because research can expose people to inconvenience, disclosure risks, discomfort, interventions, or other burdens. If the study is not capable of producing sufficiently meaningful knowledge, those burdens may be difficult to justify. The Declaration of Helsinki, for medical research, explicitly requires scientifically sound and rigorous design likely to produce reliable, valid, and valuable knowledge.
The committee therefore needs enough information about the research design to understand its ethical implications. That does not necessarily mean reproducing every methodological detail from a thesis or grant proposal.
Who will participate, and why these people?
Reviewers need to know who the intended participants are, how many are expected, and how inclusion and exclusion decisions are made. They may also need relevant characteristics of the population, depending on the study.
Participant selection raises questions of fairness as well as methodology. Why is this population appropriate for the research question? Are particular people being included because the research concerns them, or merely because they are convenient to access? Are groups bearing research burdens while others are more likely to receive the benefits of the resulting knowledge?
Additional information becomes important when circumstances may increase susceptibility to coercion, undue influence, or other forms of vulnerability. Rather than assuming that a label automatically makes an entire group vulnerable in every context, the application should explain the circumstances that create the ethical concern and the safeguards used to address it.
How will people be recruited?
The committee needs to understand how prospective participants first encounter the research. Recruitment can affect voluntariness and privacy before anyone signs a consent form.
Relevant questions may include who identifies potential participants, how they are contacted, what information recruiters can access, what recruitment materials are used, whether compensation is advertised, and whether the recruiter has authority over prospective participants.
A professor recruiting their own students, a physician recruiting patients, and an anonymous public advertisement may involve very different concerns even if all three studies ultimately use the same questionnaire.
Depending on applicable requirements, recruitment materials themselves may require ethics review.
What exactly will participants experience?
A committee cannot evaluate risks without knowing what participants will actually do.
The application should therefore describe relevant procedures in practical terms. Depending on the study, reviewers may need to know the setting, sequence, frequency and approximate duration of activities; questions or topics participants encounter; interventions or manipulations; specimens or measurements collected; recordings made; records accessed; follow-up procedures; and circumstances in which participation may be stopped.
This is where the appropriate amount of methodological detail becomes important. Detail should be sufficient for ethical evaluation rather than included merely to demonstrate methodological sophistication.
What are the foreseeable risks and burdens?
Risk is central to ethics review. The committee needs to understand what harms, discomforts, inconveniences, or other burdens may reasonably result from participation and how the research team intends to minimize them.
Risks are not limited to physical injury. Depending on the study, they may involve emotional distress, social or reputational harm, privacy intrusion, economic consequences, legal exposure, stigmatization, or disclosure of sensitive information.
The application should therefore connect the procedure to the risk and the risk to the safeguard. An interview about traumatic experiences, for example, raises different issues from a questionnaire about ordinary consumer preferences even though both involve asking questions.
The aim is to describe risks proportionately rather than exaggerating or minimizing them.
What potential benefits justify asking people to participate?
Committees may need to consider potential benefits to participants, benefits to others, and the importance or social value of the knowledge the study may reasonably produce. These are not necessarily the same thing.
A participant may receive no direct benefit even when the research could generate useful knowledge. Conversely, compensation for time or expenses is not ordinarily the same as a research benefit when evaluating the study's risk-benefit relationship.
Describe potential benefits realistically. The application should not turn uncertain possibilities into promises merely to make the study appear more favorable. The distinction matters when explaining what participants or others may potentially gain.
How will informed consent actually work?
Submitting a consent form is not the same as explaining a consent process.
Reviewers may need to know what information prospective participants receive, who provides it, when consent is sought, how questions are answered, how agreement is documented, and how the research team addresses circumstances that could compromise voluntariness or understanding.
Some research may seek a waiver or alteration of consent or consent documentation under applicable rules. In those situations, the committee needs the information necessary to determine whether the relevant criteria are satisfied rather than simply a statement that a waiver is requested.
How will privacy and confidentiality be protected?
Privacy concerns the circumstances in which researchers access or interact with people and their information. Confidentiality concerns how information entrusted to the research team is subsequently handled and protected. The distinction can matter because a study may address one well while overlooking the other.
Privacy
Concerns access to participants, their activities, spaces, communications, records, or personal information.
Confidentiality
Concerns how information obtained by the research team is protected from unauthorized disclosure.
Reviewers may need to know what identifiable or sensitive information is collected, how identifiers are handled, who can access the data, where files are stored, whether information is transferred or shared, how findings will be reported, and what happens to data after the study.
Are additional safeguards needed?
Some studies require protections beyond ordinary consent and confidentiality procedures. The need depends on the research.
Examples may include safety monitoring for an intervention, procedures for responding to participant distress, protections against coercion in dependent relationships, age-appropriate assent procedures, arrangements for participants who lack capacity to consent, management of incidental findings, or plans for research-related injury.
The important question is not whether every study contains every safeguard. It is whether the safeguards match the actual ethical issues created by the proposed research.
Who is responsible for the study, and are there interests the committee should know about?
Depending on the review system and type of research, committees may need information about investigator qualifications, research sites, funding, sponsors, institutional relationships, financial or other conflicts of interest, compensation arrangements, and the responsibilities of different members of the research team.
These details can affect whether the research can be conducted safely and independently and whether relationships or incentives could influence participant protection.
What documents allow reviewers to verify the application?
Statements in the application are often evaluated alongside the materials that implement them. These may include the protocol, participant information sheet, consent forms, recruitment advertisements, questionnaires, interview guides, data-collection forms, investigator materials, institutional permissions, or other study-specific documents.
OHRP guidance for U.S. IRBs, for example, states that initial review materials should provide sufficient detail for required determinations and identifies the full protocol, proposed consent document, relevant grant materials, investigator brochure where applicable, and recruitment materials among materials that may be reviewed.
Your own committee may require a different package. Verify the current list of supporting documents required with an ethics application rather than assuming that another institution's checklist applies.
