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Exempt from HSPC Review

Research activities in which the only involvement of human subjects is in one or more of the categories listed below may qualify for a Claim of Exemption from review by the HSPC. These exempt categories do not apply to research involving:

1. deception of subjects where the investigator does not disclose the true purpose of the research and/or the results of the subject’s participation in the study (Please see Chapter 4, "Informed Consent Requirements: Deception or Withholding Information" for more information);
2. sensitive behavioral research, or research involving pregnant women, in vitro fertilization, prisoners, the mentally disabled, or other "vulnerable" populations (Please see Chapter 8, Special Classes of Research Subjects" for more information).

In order to fulfill federal requirements for the proper review of research, investigators cannot "self-exempt" from HSPC review. Determination of exempt status is performed by the OPRS in consultation with the HSPC. Investigators are urged to consult with the OPRS staff before applying for exemption from Committee review. The Form HS-7, Claim of Exemption can be found in Chapter 12 of this manual.

NOTE: A Claim of Exemption does not necessarily exempt investigators from the requirement of gaining written informed consent from subjects. Most research requires the use an of informed consent form. For studies where there are no subject identifiers, i.e., anonymous data is collected, an information sheet or cover sheet is usually required. (Please see Chapter 4, "Informed Consent Requirements" for more information.)

Exempt categories include the following:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special educational strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Educational research proposals are exempt providing all of the following conditions are met:
   1. All of the research is conducted in a commonly accepted educational setting (e.g., private or public school).
   2. The research involves normal educational practices (e.g., comparison of instructional techniques).
   3. The study procedures do not entail a significant deviation in time or effort from those educational practices already existent in the study site.
   4. The study procedures do not involve an increase in the level of risk or discomfort beyond normal, routine educational practices.
   5. The study procedures do not involve sensitive topics such as sexual behavior of individual subjects. A sensitive survey is one that deals with socially questionable or highly personal issues or drug abuse.
   6. Provisions are made to ensure the existence of a non-coercive environment for all students, including those who choose not to participate.
   7. The school or other institution grants written approval for the research to be conducted.

Educational tests that are exempt from HSPC review are tests of:

a) knowledge; b) mastery; and c) skills. For example the following assessment program does not include individual subject identifiers or ask sensitive information from the subjects:

In order to evaluate the effectiveness of a high school AIDS prevention curriculum an investigator may ask questions such as:

"(a) Is the HIV virus carried in saliva? (b) Can condoms block the transmission of HIV? (c) Can HIV be caught by kissing?"

The test qualifies for a Claim of Exemption since the test is an objective assessment of knowledge that does not include individual subject identifiers or ask sensitive information from the subjects.

The following AIDS awareness prevention evaluation requires specific sensitive behavioral disclosures on the part of the subject and would not qualify for a Claim of Exemption unless all participation is anonymous:

(a) Have you used or will you use condoms? (b) Do you feel good about your sexuality?

2. Research involving the use of educational tests (cognitive, diagnostic aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. The OPRS is required to review copies of the informed consent form and proposed questionnaires or survey instrument(s) prior to approval and implementation.

Anonymous data:

Investigators should note that a survey is anonymous when there is no possible way to identify the participants from the data collected. anyone, or any procedure Data are not anonymous if such as accessing a computer database, will identify the subject. In most specific identifiers, instances, the omission of names or other such as social security numbers, is sufficient to qualify a study as anonymous.

Sometimes an investigator may preserve a subject’s anonymity while still retaining data on individual characteristics such as age, gender, ethnic origin, occupation, or diagnosis. Anonymity is possible only when studying large samples or populations. When the number of potential participants is small or the research setting is identified, anonymity can be threatened or compromised even when names are removed from the data. A case in point:

A study consists of a survey of sociology students at a large university. The survey does not ask subjects to identify themselves by name or social security number. Subjects, however, may be easily identified by their citizenship, age, or ethnicity which serve as markers that may compromise their anonymity.

NOTE TO INVESTIGATORS: Observational research involving sensitive aspects of subjects’ behavior, or in settings where subjects have a reasonable expectation of privacy, is not exempt. Similarly, sensitive survey research is seldom exempt from HSPC review (see below for exceptions). A sensitive survey includes questions about illegal activities or highly personal aspects of the subjects’ behavior, life experiences, or attitudes. Examples include chemical substance abuse, sexual activity or attitudes, sexual abuse, criminal behavior, sensitive demographic data, detailed health history, etc. The potential for provoking a negative emotional reaction from subjects is a principal determining factor of sensitive survey research.

Additional consideration for exemption includes whether there is a risk associated with a possible breach of confidentiality (i.e., accidental disclosure of drug use to law enforcement personnel). In surveys with potential psychological risk, review for exemption includes risks associated with surveys about sensitive topics as well as those resulting from a breach of confidentiality. When confidentiality is an issue, the presence or absence of subject identifiers may be a decisive factor.

Questionnaires or surveys covering sensitive topics may qualify for a Claim of Exemption if they fulfill the following:

1. anonymity of the subject is guaranteed,
2. potential subjects are informed of the sensitive nature of the topics prior to their participation, and
3. the study does not exceed minimal risk.

(Please see Chapter 5, "Risk/Benefit Assessment," for a discussion of the terms "benefit," "risk," and "minimal risk".)

In a few studies, there is a potential for identifying participants through other descriptions in the data set. The following study, if it contains sensitive content, would not qualify for a Claim of Exemption:

A survey instrument asks college professors for their field of study and their date of degree. Some participants would be identifiable from the data alone.

NOTE TO INVESTIGATORS: Research using survey or interview procedures does not qualify for a Claim of Exemption if children are involved as subjects. In addition, observation of children is not exempt from Committee review if the researcher participates in or influences the observed activities.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) (b) of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office or (b) federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Copies of the informed consent form and questionnaires or survey instrument(s) to be used must be forwarded to the OPRS for review.

4. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. The source of data, documents, records, pathological specimens or diagnostic specimens must be provided to the HSPC.

The term "existing" refers to the time period that the data and/or material was obtained and does not necessarily mean that the data and/or material was obtained for clinical or diagnostic purposes. OPRR has informed the HSPC that the term "existing" refers to material or tissue that is "archived" or "on the shelf" prior to HSPC review of the research. The federal regulations also require that the HSPCs distinguish between residual material or tissue and extra material or tissue gathered from diagnostic or clinical procedures to be used in research.

Residual Biological Material or Tissue/A Prospective Study:

The HSPC is required to review research requesting the use of residual biological material, i.e., blood, tissue, other bodily fluids, etc., that is no longer needed for clinical/diagnostic purposes ("archived" or "on the shelf") if the material or tissue is not archived prior to submitting the protocol for HSPC consideration. Exemption status is based upon whether the material is archived or exists prior to submission of the protocol for HSPC review. For example:

Dr. Jones knows that Dr. Smith will perform a tumor biopsy on her cancer patients. Dr. Jones wants to analyze tumor tissue in order to test a theory. Dr. Jones requests the use of the residual material, without subject identifiers, that Dr. Smith will otherwise dispose of over the next year. The research proposed by Dr. Jones will not qualify for a Claim of Exemption because the material he requests is not available until after HSPC review of the project. In other words, the material is not archived at the time of the HSPC review of the research.

Since Dr. Jones’ research does not qualify for a Claim of Exemption he should submit the Form HS-1 application and other materials appropriate to the HSPC review of the project.

The HSPC is also required to review research with residual material where the investigator intends to identify the patient/subject donor with the acquired sample, either for future purposes or with the intent that the research results may have implications for diagnostic or clinical decisions. Please submit the Form HS-1 application and other appropriate materials to the HSPC for review of the project.

Residual Biological Material or Tissue/A Retrospective Study:

A study that proposes to retrospectively examine archived or residual material that does not contain patient/donor identifiers may qualify for a Claim of Exemption. For example:

Dr. Jones knows that Dr. Smith performed tumor biopsies on her cancer patients. Dr. Jones wants to analyze tumor tissue in order to test a theory. Dr. Jones requests the use of the residual samples without patient/donor identifiers that Dr. Smith obtained through clinical biopsy over the last six months. Since Dr. Jones proposes a retrospective study of archived material without patient/donor identifiers, the project does qualify for a Claim of Exemption.

Extra Biological Material or Tissue/A Prospective Study:

Requests for additional material, i.e., blood, tissue, bodily fluid, from a patient or subject who is scheduled for a diagnostic or clinical procedure are not exempt from HSPC review. This type of study would prospectively, or prior to the procedure, request for research purposes, the obtaining of extra material. Committee review is required regardless of the amount of extra material requested and regardless of the purpose for which it is procured. Please submit the Form HS-1 application and other appropriate materials to the HSPC for review of the project.

NOTE TO INVESTIGATORS: research involving human ova (fertilized or not) is not exempt.

5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternative to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

This category may also be applied to service/program evaluations of State, City or County programs providing: (a) the program being studied delivers public benefits or services; (b) there is specific statutory authority over the program; (c) there is no statutory requirement that the program evaluation plan be reviewed by an IRB; and (d) there is no significant intrusion or invasion of the privacy of the participant.

6. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspections Service of the U.S.Department of Agriculture.