03 · What You Need to Know
How an Exemption Determination Is Actually Made
First, Separate Eligibility From Authority
Two questions are easy to collapse into one:
- Does this protocol satisfy the substantive criteria for an exemption?
- Who has authority to make or document that determination?
The first concerns eligibility. The second concerns procedure and authority.
A researcher may be completely correct that a study satisfies an exemption category but still be required to submit the protocol to an authorized person or body for the formal determination. Conversely, submitting something as “exempt” does not make it exempt if the substantive criteria are not met.
Researcher assessment
Your reasoned judgment that the protocol appears to satisfy an applicable exemption category.
Formal exemption determination
The decision recognized under the applicable institutional or regulatory process that the protocol qualifies for exemption.
In the Philippines, the REC Makes the Exemption Decision
The 2022 National Ethical Guidelines for Research Involving Human Participants are unusually explicit on this point. After a protocol package is received and checked for completeness, the REC Chair or representative determines whether the proposal is exempt or requires full or expedited review.
The guidelines define “Exempt from Review” as a protocol that does not need full or expedited review after preliminary assessment by a designated REC member. They then state directly that “Exempt from Review” is a decision made by the REC.
For researchers working under this framework, the distinction is therefore straightforward: you can identify reasons why you think the protocol qualifies, but your expectation does not replace the REC's determination.
U.S. Federal Rules Leave More of the Procedure to Institutions
Under the U.S. Common Rule, the regulatory structure is somewhat different. The revised Common Rule identifies exemption categories at 45 CFR 46.104, but the regulations do not generally specify which person at an institution must determine that a study qualifies for exemption. OHRP states that institutions may establish their own procedures for making accurate exemption determinations.
OHRP nevertheless recommends that, because of the potential conflict of interest, investigators should not be given authority to make an independent determination that their own human-subject research is exempt. Institutions commonly assign this function to staff in an IRB or Human Research Protection Program office or another appropriately trained and authorized person.
Some U.S. Exemptions Specifically Require Limited IRB Review
There is another wrinkle. Under the revised U.S. Common Rule, several exemption provisions incorporate limited IRB review as a condition of the exemption. In those circumstances, the regulations specifically require an IRB to make particular determinations, such as whether adequate provisions exist to protect privacy and maintain confidentiality.
So even within one regulatory system, there is no single procedural sentence that accurately describes every exemption.
Why Not Simply Let Researchers Decide?
The issue is not that researchers are incapable of reading ethics regulations. Many investigators understand the relevant rules very well. The problem is structural.
Researchers have an obvious interest in getting their projects started. They may also be less familiar with technical regulatory definitions than staff who apply them repeatedly across many protocols. Independent or institutionally designated determination can reduce conflicts of interest, improve consistency, and create a documented record of why an exemption was applied.
OHRP specifically identifies potential investigator conflict of interest as a reason for recommending against independent investigator determinations. It also advises institutions to ensure that authorized decision-makers have sufficient information, appropriate tools or training, and clear institutional procedures.
Does the Entire Ethics Committee Have to Meet to Declare a Study Exempt?
Not necessarily. Requiring a full convened committee meeting merely to determine that a study qualifies for exemption would defeat much of the procedural distinction between exemption and full review.
In the Philippine framework, preliminary assessment can be conducted by a designated REC member, with the REC Chair or representative determining exemption or the appropriate review pathway. In other systems, trained IRB or research-office staff may be authorized to make exemption determinations.
Who performs the assessment should therefore be distinguished from whether the full committee convenes.
What Does the Decision-Maker Actually Examine?
An exemption determination should be based on the actual protocol rather than its title. The authorized reviewer needs enough information to establish what the researcher will do, who or what is involved, what information will be collected, whether individuals can be identified, what risks could arise, and whether every condition of the claimed exemption is satisfied.
For that reason, an institution may ask researchers to submit a protocol, exemption application, questionnaire, interview guide, recruitment material, data description, or other documents even though the study may ultimately be exempt from ordinary review.
The paperwork is not proof that the study underwent full ethics review. It may simply provide the information necessary to decide whether review is required.
An Exemption Determination Should Identify the Basis for Exemption
Good exemption procedures do more than produce a generic “exempt” label. OHRP recommends that the record identify the specific exemption category or categories supporting the determination and that this information remain available for oversight and audit.
This can also be useful to the researcher later. If a journal, collaborator, sponsor, or institutional office asks why ethics review was not conducted, a documented determination is considerably more informative than “I believed it was exempt.”
Institutional Rules Can Be More Restrictive Than the Regulatory Minimum
A regulation may permit an exemption without requiring a particular institutional procedure, yet an institution can impose its own research-governance requirements where legally permissible. OHRP explicitly recognizes institutional variation in how exemption authority is configured and notes that institutions may establish policies suited to their local research programs.
Researchers should therefore check both the applicable regulation and their institution's procedures. Knowing that a federal rule does not require a particular step does not necessarily mean your institution has omitted that step from its own process.
What if the Study Changes After It Was Declared Exempt?
Exemption applies to the study as assessed. Changes can matter.
Suppose an anonymous questionnaire is later modified to collect names, a nonsensitive interview begins asking about illegal activity, children are added as participants, or a dataset that was originally de-identified becomes linkable to individual records. The basis for the original determination may no longer apply.
OHRP recommends consulting the appropriate institutional authority when proposed changes could make exempt research nonexempt. Institutions may establish procedures for evaluating such changes even where the regulations do not require continuing IRB review of exempt research.
Watch Out
An exemption letter is not a permanent label attached to whatever the project later becomes. If you materially change the participants, procedures, data, risks, or other features supporting the exemption, check whether the determination still applies before implementing the change.
Exemption and “Not Human-Participant Research” Are Different Determinations
Another procedural distinction is worth preserving. An activity can fall outside the applicable human-participant research framework, or it can fall within that framework but satisfy an exemption. Those are not necessarily the same conclusion.
OHRP recommends a sequential assessment under the U.S. framework: determine whether the activity is research, whether it involves human subjects, and, if so, whether an exemption applies. Institutions commonly designate knowledgeable personnel to make these determinations because the definitions can be technical.
Using the correct determination matters because it explains why ordinary IRB review is not required.
04 · A Practical Example
From “I Think It Is Exempt” to a Formal Determination
Hypothetical Example
An Anonymous Survey Appears to Qualify
A university researcher plans an anonymous online survey of adults about ordinary study habits. The questions are nonsensitive, participation is voluntary, and the researcher believes the study satisfies the institution's exemption criteria.
Researcher assessment
The researcher compares the complete protocol with the applicable exemption criteria and identifies the category that appears relevant.
Institutional submission
The researcher follows the university's exemption procedure and provides the protocol and survey instrument to the authorized research-ethics office.
Independent determination
The authorized reviewer checks whether the project actually satisfies all relevant conditions rather than relying on the researcher's description of it as “anonymous and low risk.”
Documentation
The institution issues an exemption determination identifying the status of the study under its process.
Research begins
The researcher starts the covered research activities only after completing the required institutional process.
Nothing about this process implies distrust of the researcher. It separates the investigator's useful preliminary assessment from the institutionally recognized determination.
