Human Research Review

1. Activities that may require human research review

Review may be required when a project is designed to develop or contribute to generalizable knowledge and involves living individuals, identifiable information, or identifiable biospecimens.

2. Activities that may not constitute human-subject research

Some activities may fall outside formal human-research review, depending on their purpose, methods, information, and intended use.

• routine internal operations or program administration;
• quality-improvement activities intended only for local use;
• journalism, biography, oral history, or historical scholarship focused on particular individuals or events;
• analysis of fully public, nonrestricted, nonidentifiable information;
• authorized institutional evaluations not designed to produce generalizable research findings;
• public demonstrations or educational exercises without research data collection.

An activity may still require privacy, legal, archival, safety, accessibility, data-governance, or institutional approval even when formal human-research review is not required.

3. Possible review determinations

4. Information needed for review

A human-research submission should provide enough detail for reviewers to understand what participants will experience and how their rights and information will be protected.

• research question, purpose, and expected contribution;
• study design and methods;
• participant population and eligibility criteria;
• recruitment methods and materials;
• consent, assent, and parental-permission documents;
• surveys, interview guides, scripts, and study instruments;
• procedures, interventions, recordings, and measurements;
• anticipated risks, discomforts, burdens, and benefits;
• privacy, confidentiality, data security, and retention plans;
• compensation, reimbursement, incentives, or costs;
• investigator qualifications, training, and supervision;
• funding, conflicts, collaborators, sites, and agreements.

5. Informed consent

Consent should provide understandable information so that a reasonable person can decide whether to participate.

Consent materials should generally explain:

• that the activity is research;
• the purpose and expected duration;
• what the participant will be asked to do;
• reasonably foreseeable risks or discomforts;
• expected benefits, if any;
• alternatives when relevant;
• how privacy and confidentiality will be handled;
• whether information or biospecimens may be shared or reused;
• compensation, costs, or treatment for research-related injury when relevant;
• whom to contact with questions or concerns;
• that participation is voluntary and may be ended without improper penalty.

6. Risk, burden, and expected benefit

Risks should be reasonable in relation to the anticipated benefits and the importance of the knowledge expected from the research.

Review should consider:

• physical injury or discomfort;
• psychological stress, embarrassment, or emotional harm;
• loss of privacy or confidentiality;
• economic, employment, educational, legal, immigration, or reputational harm;
• family, community, cultural, or group-level harm;
• cybersecurity, surveillance, location, or reidentification risk;
• burdens created by time, travel, procedures, or repeated contact;
• risks arising from authority relationships or institutional dependence.

Researchers should use less risky methods when they can answer the question adequately.

7. Fair participant selection and recruitment

Participant selection should be scientifically justified and should not unfairly place research burdens on groups unlikely to benefit from the knowledge produced.

• Eligibility criteria should relate to the research question.
• Recruitment should avoid deception, undue pressure, and misleading claims.
• Compensation should reimburse time and burden without becoming an improper inducement.
• Access should not be restricted without a defensible reason.
• Recruitment materials should use clear, accurate, and accessible language.
• People in dependent relationships should have meaningful freedom to decline.

8. Vulnerable or potentially dependent populations

Additional safeguards may be needed when participants have limited decision-making authority, face institutional dependence, or may be especially susceptible to pressure or harm.

• children and adolescents;
• people with impaired decision-making capacity;
• incarcerated or detained individuals;
• students, employees, patients, or subordinates recruited by people with authority over them;
• people experiencing economic, housing, immigration, medical, or social vulnerability;
• communities affected by historical exploitation or research abuse;
• participants in secure, residential, healthcare, educational, or correctional settings.

9. Privacy, confidentiality, and data protection

Researchers should collect only information justified by the research and should limit access to authorized personnel.

• Use private settings for recruitment, consent, interviews, and sensitive procedures.
• Separate direct identifiers from research data when practical.
• Use coded identifiers, encryption, access controls, and secure transfer methods.
• Explain recording, photography, video, location tracking, and sensor collection clearly.
• Define retention, deletion, preservation, sharing, and repository plans.
• Address risks of reidentification, linkage, and secondary use.
• Use data-sharing agreements where collaborators receive protected information.
• Report privacy or security incidents promptly.

10. Changes, deviations, complaints, and incidents

Material changes to approved research should be reviewed before implementation unless immediate action is necessary to protect participants.

Prompt reporting may be required for:

• unexpected injuries, distress, or participant complaints;
• privacy breaches or unauthorized disclosure;
• deviations from the approved protocol;
• changes in risk or new safety information;
• failure of consent or recruitment procedures;
• loss of data, devices, records, or biospecimens;
• investigator noncompliance or inadequate supervision;
• complaints of coercion, retaliation, discrimination, or unfair treatment.

Review bodies may require corrective action, additional consent, notification, retraining, suspension, termination, data restriction, or external reporting.

11. Continuing review and project closure

Projects may require periodic review based on their risk, duration, participant population, sponsor requirements, or governing rules.

Closure documentation should address:

• whether participant interaction and data collection are complete;
• the status of follow-up obligations and unresolved concerns;
• how identifiable data and biospecimens will be retained or destroyed;
• whether information will be deposited in a repository;
• publication, correction, and communication plans;
• any long-term participant, community, or safety obligations.

12. Request a human research determination

Until a dedicated submission system and formal review body are active, researchers may contact the Institute for a preliminary determination or referral to an external IRB.