IRB for Beginners: Mobile Clinic Research Guide

Begin with four questions

1. Is the activity research?

Under the federal Common Rule, research is a systematic investigation designed to develop or contribute to generalizable knowledge. Many activities are systematic, so that feature alone does not make an activity research. The project’s purpose and the intended use of the knowledge also matter.

2. Does the research involve human subjects?

Human-subjects research generally involves an interaction or intervention with a living person to obtain information or biospecimens. It can also involve obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens, as defined by the applicable regulations.

3. Does an exemption apply?

Federal regulations describe categories of research that may be exempt from some Common Rule requirements. “Exempt” does not mean the team can make that decision or skip the institution’s process. An authorized office should determine whether an exemption applies. Some exempt research may require limited IRB review, and privacy, consent, contractual, or legal requirements may still apply.

4. What level and type of review are required?

Depending on the activity and the rules that apply, the pathway may be a determination that the activity is not human-subjects research, an exemption, expedited review, or review by the convened IRB. The IRB or other authorized institutional office decides which pathway is appropriate.

Research, program evaluation, and quality improvement

Program evaluation and quality improvement often use interviews, surveys, records, or outcome data. The methods alone do not determine whether the activity is research.

A quality improvement project that implements an accepted practice and measures local clinical or administrative performance may fall outside the federal definition of research. An activity may meet the definition of research when it is also designed to produce generalizable evidence, particularly when it tests an intervention or uses a research design for that purpose.

The intent to publish does not, by itself, make a quality improvement project research. A project may be research even when the team does not plan to publish.

When the boundary is unclear, request a written determination.

IRB review and HIPAA are separate

IRB review addresses protections for research participants under applicable human-subjects rules. The HIPAA Privacy Rule governs certain uses and disclosures of protected health information by covered entities and business associates. A project may be subject to both. IRB approval does not automatically authorize every use or disclosure of health information.

Review the Data Privacy and Data-Sharing Standards early in planning.

What to prepare for an IRB submission or determination

Requirements vary, but teams commonly need:

Plain-language project summary
Research question and rationale
Study design and procedures
Study population and eligibility criteria
Recruitment locations, methods, and materials
Consent, assent, authorization, or waiver request
Surveys, interview guides, scripts, and data collection forms
List of data elements and sources
Privacy and data-security plan
Risk and benefit assessment
Participant payment plan
Language access and disability accommodations
Protections for participants who may face added vulnerability or pressure
Roles of program staff, researchers, and community partners
Data-sharing and reliance agreements, when applicable
Plan for reporting unexpected problems and changes
Plan for returning and publishing results
Training and conflict-of-interest documentation

Allow time in the project schedule for questions and revisions.

How to find an IRB if your organization does not have one

Many mobile healthcare programs do not have an IRB within their organization. This is common among Federally Qualified Health Centers, non-academic hospitals, smaller health departments, and community-based organizations. An organization does not have to establish its own IRB solely to take part in research. It may be able to rely on an external IRB.

Start by identifying the person within your organization who can approve a research oversight arrangement. Depending on the organization, this may be a chief executive, clinical leader, compliance or privacy officer, research administrator, or legal counsel. This person should be involved even when another organization provides the IRB review.

Then ask the research partners, sponsor, or funder whether the project already has a reviewing IRB. Common options include:

The IRB of a university, academic medical center, health system, or other research partner
An IRB used by a parent organization, affiliate, research network, or consortium
A central or single IRB selected by the study sponsor
An independent IRB that reviews research for organizations without their own boards, usually for a fee

Not every IRB accepts studies from outside organizations. Contact prospective IRBs early and ask:

Will the IRB review this type of study for our organization?
Does it have experience with the population, setting, and methods involved?
How will it consider local laws, community context, language, and standard of care?
What are the fees, submission requirements, and typical review timelines?
Who will review amendments, unexpected problems, continuing oversight, and study closure?
What responsibilities remain with our organization?
What reliance or authorization agreement is required?
Does our organization need a Federalwide Assurance for this project?

The Office for Human Research Protections maintains a database of registered IRBs. The database can help identify or verify an IRB, but registration is not accreditation and does not show that an IRB is willing or qualified to review a particular study. The organization still needs to assess the IRB’s fit and make the required arrangements.

When an organization relies on an external IRB, the relationship and each party’s responsibilities should be documented in writing. For HHS-conducted or HHS-supported non-exempt human-subjects research, an organization that is engaged in the research generally must have an active Federalwide Assurance and rely on an IRB registered with OHRP. Confirm the requirements with the reviewing IRB, funder, and appropriate institutional officials before research begins.

Multi-site research and reliance agreements

A study involving a university, health system, mobile program, and several community sites may involve more than one institution. In some cases, institutions can rely on one reviewing IRB through a reliance or IRB authorization agreement. Federal single-IRB requirements may apply to certain cooperative research.

Ask early:

Which institution will serve as the reviewing IRB?
Which organizations are engaged in the research?
Which organizations will rely on the reviewing IRB?
Who will handle local context, conflicts, training, and reporting?
Which activities can begin before all agreements are complete?

Do not assume that approval from a university IRB automatically covers every participating organization.

After approval

IRB responsibilities continue after initial approval. Follow the approved protocol and consent process. Submit amendments before changing the research, unless an immediate change is necessary to eliminate an apparent hazard. Report unexpected problems and other events as required. Track approval periods and any continuing review requirements, and close the study through the required process.

Common IRB terms

Exempt research

Research that fits a regulatory exemption category. An institutional determination is generally still required.

Expedited review

Review by the IRB chair or designated experienced reviewer for certain research that presents no more than minimal risk and fits an eligible category. “Expedited” describes the regulatory pathway, not a guaranteed turnaround time.

Convened or full-board review

Review at a meeting of the IRB with the required membership and quorum.

Reliance agreement

An agreement documenting that one institution will rely on another institution’s IRB review for specified research.

Federalwide Assurance

An assurance through which an institution commits to complying with federal human-subjects protection requirements for covered research.

Amendment

A proposed change to approved research. Most changes require approval before implementation.

Frequently asked questions

Do we need IRB review if we want to publish?

Plans to publish do not, by themselves, determine whether an activity is research. The purpose and design determine whether it meets the regulatory definition. Ask for an institutional determination before the project begins.

Do we need IRB review for de-identified data?

Research using data that investigators cannot readily link to individuals may not involve human subjects under the Common Rule. That depends on how the data were obtained and what access investigators have. HIPAA and other rules use specific standards for de-identification, so request the appropriate determination.

It depends on the exemption, activities, institutional policy, and other applicable requirements. Exemption from parts of the Common Rule does not erase ethical, privacy, or organizational responsibilities.

Can the researcher’s university IRB cover the mobile program?

Sometimes. The organizations may need a reliance agreement and must determine which activities and institutions are covered. Make this decision before research begins.

Does our organization need to create its own IRB?

Usually not. An organization may be able to rely on the IRB of a research partner, a sponsor-designated central IRB, or an independent IRB. The arrangement must be accepted by both organizations and documented as required. The mobile program still retains institutional responsibilities for the research it conducts.

Can we begin recruiting while the IRB reviews the project?

Do not begin recruitment, consent, research procedures, or research data access until all required determinations, approvals, agreements, and permissions are in place.

Authoritative resources

All research resources

Reviewed by: Mollie Williams, DrPH, MPH
Last reviewed: 2026-08-28