Exempt Research

Exempt research is so named because it is exempt from some of the federal regulations; however, it is not exempt from state laws, institutional polices, or the requirements for ethical research. The 麻豆免费版下载Boulder IRB makes determinations of exemption.

To qualify for exemption, the entirety of the research must fit into one or more of the Exempt Categories as described in . While the regulations define eight categories, most鈥攊f not all鈥攅xempt research at 麻豆免费版下载Boulder falls within Categories 1鈥4. The information on this page is limited to Categories 1鈥4. If you believe your research fits into one of the categories not described here, please contact the IRB for assistance.

 

Informed consent in Exempt research

The requirement to document informed consent does not apply to Exempt research. However, since informed consent is one of the most important aspects of research ethics, the 麻豆免费版下载Boulder IRB requires a consent process for all research involving an interaction with participants, whether it be in-person or remote. 

Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research. It is important to understand that even though consent may not be documented with a signature, as is the case with much of exempt research, consent is still being obtained. For example, when a consent script that contains basic elements of consent is used for a phone survey, the participant may choose whether or not to proceed with the survey based on the information provided. That is consent; it is not implied.

In-person consent

When there is in-person interaction between the PI and a participant, the PI should provide a physical copy of the consent information. The PI can explain/discuss the consent information with participants and obtain verbal confirmation of consent or participants can sign the consent form. Use the Exempt In-Person Consent Template for research that involves in-person interaction.

Remote consent

Remote interaction includes online surveys or interviews, telephone surveys or interviews, and interactions that occur via video calls (Zoom, etc.). Participants should be provided the consent information before their participation begins. This can be including the consent text as the first item in an online questionnaire with a 鈥渃lick to consent鈥 option or reading the consent information to participants and obtaining a verbal confirmation of consent from participants. Use the Exempt Remote Consent Template for research that involves remote interaction.

Who can participate in Exempt research?

Federal regulations limit which special populations can participate in Exempt research:

  • Pregnant women can participate in research in any Exempt Category.
  • Prisoners cannot participate in any Exempt Category (i.e. prisoners cannot be a target population).
  • Children may participate in Categories 1 and 4 without limitations and in Category 2(i) and 2(ii) if the research only involves educational tests or the observation of public behavior when the investigator does not participate in the activities being observed.

The 麻豆免费版下载Bouder IRB created templates specific to exempt research: Exempt Protocol, Exempt In-Person Consent, Exempt Remote Consent. These documents must be used when creating an Exempt Initial Application. There are no deadlines for submitting Exempt research, but no research activities can occur until you receive an Exempt Determination letter from the IRB.

Use the to help you decide if your research qualifies for exemption. Note: the results are not an official IRB determination.

   A note about the verbiage used on this page. The use of the term 鈥渟ubject鈥 is limited to language taken directly from the federal regulations. The 麻豆免费版下载Boulder IRB encourages the use of the term 鈥減articipant,鈥 which is used in all other areas of this page.

Key takeaways

  • Exempt determinations are made by the 麻豆免费版下载Boulder IRB
  • The entirety of the research must fit into one or more Exempt Categories
  • Informed Consent documentation (signatures) is not required, but an informed consent process is
  • Some special population participation is limited
  • Use the Exempt templates
  • No submission deadlines for Exempt research

Exempt Research Categories

Category 1: Educational Practices Category 2: Educational Tests, Surveys, Interviews or Observation of Public Behavior Category 3: Benign Behavioral Interventions Category 4: Secondary Use of Data
Category 1: Educational Practices

Category 1: Educational Practices

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students鈥 opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods. [45 CFR 46.104(d)(1)]

Established or commonly accepted educational settings

Defined as: Settings where one would go to have an educational experience that is regularly offered in the location where the research will be conducted or that is commonly accepted in a specific culture or population.

These settings could include but are not limited to:

  • Schools and universities
  • Workplace educational programs and sites
  • Libraries (e.g., adult learning classes)
  • Boy or Girl Scout meetings
  • Education in applied settings such as grocery stores that offer cooking or nutrition classes; a bicycle shop that offers repair and maintenance classes; woodworking instruction in a 鈥渕aker space鈥; craft classes in a craft store, etc.
  • Professional development seminars or programs (e.g. Toastmasters)

Normal educational practices

Defined as: Activities that could occur in the specific educational setting regardless of whether the research is conducted. This includes a variety of activities that normally occur in the classroom or that are considered "best practice." Examples include established teaching methods (not considered to be experimental) or curriculum, and commonly accepted classroom management techniques that are planned and implemented by the classroom teacher.

NOTE: Family Education Rights and Privacy Act (FERPA) and Protection of Pupil Rights Amendment (PPRA) regulations may apply to some research in educational settings. See the K-12 Education Research Guidance Document for more information.

Special populations

Pregnant women can participate.

Prisoners cannot participate as the target population.

Children can participate.

  • A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
  • A study comparing two curricula that are currently being implemented (or one that is current but recently replaced an older version). Researchers will observe classrooms as well as interview instructors about their experiences implementing the instructional materials and collect class evaluations.
  • A study comparing driver's education curricula offered by area driving schools. The researcher will observe classes and compare driving test scores at the end of the courses.
  • A study involving interviews of third grade teachers regarding their experiences and techniques with implementing new math standards. Researchers will obtain lesson plans and ask the teachers to provide reflective journals for one week.
  • A study evaluating homework stress by interviewing 8th grade students on the amount of homework they receive and surveying their parents about their perceived stress level and sleep habits of their children. No questions of sensitive nature.
  • A study evaluating pharmacy continuing education.

Category 2: Educational Tests, Surveys, Interviews or Observation of Public Behavior 

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

  1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.
  2. Any disclosure of the human subjects鈥 responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects鈥 financial standing, employability, educational advancement, or reputation; or
  3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 搂46.111(a)(7).

[45 CFR 46.104(d)(2)]

Limited review

Limited review requires the IRB to determine that there are adequate provisions for protecting confidentiality and privacy. This information is discussed in the Data Management and Provisions to Protect the Privacy Interests of Participants sections in the Exempt Protocol Template. The template provides information about what is needed to satisfy this requirement.

Key points about identifiability

  • Anonymous: No one (PI, research staff, other participants) can know if someone even participated in the research. For example, leaving a survey with an unmonitored collection box in a public place that the PI will collect after a certain amount of time has passed.
  • Recorded in such a manner that the identity of the participant cannot readily be ascertained: There is an interaction with an individual for research purposes, but no identifiable data is connected to the research directly or through a coding system.
    • Online surveys cannot collect URLs, IP addresses, email addresses.
    • In-person surveys cannot be returned in a manner where researchers can see who participated
    • Video/audio recordings and photographs are identifiable. They can be deidentified by removing names during transcription or using software to blur faces and identifiable characteristics.
    • Interviews/focus groups are identifiable. They can be deidentified by not recording names or removing names during transcription.
  • Recorded in such a manner that the identity of the participant can readily be ascertained: Parts (ii) and (iii) allow data to be collected with identifiers. The PI should code the data to protect participants.

Definitions

  • Risk of disclosure (Part ii) means that the research can be exempt only when there are no significant detrimental consequences to the participant if identifiable information were disclosed outside of the research. Whether consequences would be significant and detrimental depends in part on context. For example, including a question about sexual identity in an interview study that investigates adults鈥 plans to change careers could be non-controversial (and exempt) in some locales but highly sensitive (and therefore non-exempt) in other places.
  • Sensitive topics include, but are not limited to, questions about sexual activity, drug use, political/ religious affiliations or opinions, medical diagnosis, illegal activity, or other questions whose answers could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants鈥 financial standing, employability, educational advancement, or reputation.
    • Sensitive topics may be included in Exempt Category 2 research if exposure to the questions themselves does not cause harm. For example, an anonymous questionnaire about sexually transmitted disease history may be acceptable under Exempt review, but questions regarding sexual abuse will require Expedited or Convened review. In the latter, a participant鈥檚 mere exposure to the question may elicit stress recounting emotional or disturbing events in their lives. In this case, you will need to submit a Non-Exempt Initial Application.
  • Public behavior refers to behavior taking place in a publicly accessible location in which the subject does not have an expectation of privacy (e.g., a public plaza or park, a street, a building lobby, a government building). If participants have a reasonable expectation of privacy (e.g. medical exam room, private office) at the location where the researcher is conducting the observation, the project is not exempt.

Special populations

Pregnant women can participate.

Prisoners cannot participate as the target population.

Children can participate in Parts (i) and (ii) if the research only involves educational tests or the observation of public behavior when the investigator does not participate in the activities being observed.

  • A study involving an online survey regarding workplace satisfaction at area firms.
  • An observational study of children playing in a public park; the researcher takes notes of what occurs, recording children鈥檚 gender, race, and length of activity, but the researcher does not participate in the activities or interact with participants.
  • Surveying teachers, nurses, or doctors about a technique or an outcome.
  • Interviewing managers about a management style or best practice.
  • Conducting a focus group about an experience or an opinion of a community program.
  • A reading comprehension test that asks the participant to read a passage and then answer questions about it.
  • A focus group involving college students and their STEM experiences.
  • A study involving focus groups with expectant mothers regarding their understanding of post-partum depression. 
  • A study involving an identifiable survey of college seniors regarding recreational drug use. (This is a study that would require limited IRB review.) 

Category 3: Benign Behavioral Interventions 

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

  1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  2. Any disclosure of the human subjects鈥 responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects鈥 financial standing, employability, educational advancement, or reputation; or
  3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 搂46.111(a)(7).

[45 CFR 46.104(d)(3)]

Benign behavioral interventions

Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on participants, and the investigator has no reason to think the participants will find the interventions offensive or embarrassing. They can involve the performance of a cognitive, intellectual, educational or behavioral task or the manipulation of the participant鈥檚 physical, sensory, social or emotional environment. Brief in duration means no more than a few hours in a single day or visit.

   Note: Category 3 only allows for certain types of data collection methods. The only data collection methods allowed under this exemption category are verbal or written responses (e.g. surveys or interviews, test responses, data entry), observation or audiovisual recordings. Data cannot be collected via physical procedures such as blood pressure monitoring, EEG, activity trackers (e.g. Fitbit), eye trackers or blood draws.

Limited review

Limited review requires the IRB to determine that there are adequate provisions for protecting confidentiality and privacy. This information is discussed in the Data Management and Provisions to Protect the Privacy Interests of Participants sections in the Exempt Protocol Template. The template provides information about what it needed to satisfy this requirement.

Key points about identifiability

  • Recorded in such a manner that the identity of the participant cannot readily be ascertained: There is an interaction with an individual for research purposes, but no identifiable data is connected to the research directly or through a coding system.
  • Recorded in such a manner that the identity of the participant can readily be ascertained: Parts (ii) and (iii) allow data to be collected with identifiers. The PI should code the data to protect participants.

Deception

This exemption does not permit the use of deception unless participants are told prior to their participation that they will be unaware of or misled about the nature or purposes of the research and they agree to participate. Debriefing is encouraged.

Special populations

Pregnant women can participate.

Prisoners cannot participate as the target population.

Children cannot participate.

  • Participants are asked to take part in two two-hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software. The procedures are conducted during a single visit, and participants are encouraged to take breaks when desired.
  • A study asking graduate students to browse a popular social networking site and then time their efforts to solve a complex word puzzle.
  • A random assignment of participants to take a test under various noise conditions.
  • A study involving interviews with college seniors (age 18 and older) about their career plans after reviewing a documentary on job growth in various sectors.
  • A group of expectant mothers are asked to screen educational material regarding post-partum depression and are interviewed regarding their understanding of post-partum depression. (This is a study that would require limited IRB review.)

Category 4: Secondary Use of Data

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

  1. The identifiable private information or identifiable biospecimens are publicly available;
  2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects and the investigator will not re-identify subjects;
  3. The research involves only information collection and analysis involving the investigator鈥檚 use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Research under Parts (iii) and (iv) is very rare at 麻豆免费版下载Boulder. Therefore, the information on this page will focus on Parts (i) and (ii).

   Note: This category is limited to the secondary use of information and biospecimens only. It does not cover any primary collection of information or biospecimens.

Part i

In most cases, publicly available datasets or biospecimens are de-identified and do not require IRB oversight. Part (i) allows that some public datasets do contain private, identifiable data.

Part ii

The data or biospecimens obtained may contain dates (date of birth, date of graduation, date of event, etc.) and geographic locations except street address. However, if these data in combination with other factors in the dataset or when combined with other available datasets allow the identity of the participant to be ascertained, the research will not meet this Category 4 exemption criteria.

Names, email address, phone/fax number, street address, SSN, medical record number, health plan beneficiary number, account numbers, certificate or license numbers, vehicle identifiers and serial numbers, device identifiers and serial numbers, biometric identifiers (e.g., fingerprint), URLs, IP addresses, or full photographic images are not allowed under part ii of this exemption.

Definitions

  • Secondary means the re-use of identifiable information and identifiable biospecimens that are collected from some other 鈥減rimary鈥 or 鈥渋nitial鈥 activity (i.e. data that were not collected for the purpose of the specific proposed study).
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Publicly available (Part i) describes identifiable information or biospecimens that are available from public entities such as the following:
    • Libraries
    • Online data repositories if the only requirement for obtaining the information is paying a user fee, registering, or signing in as a visitor.  If access to the data is 鈥渓imited鈥 or 鈥渞estricted,鈥 then the data set is likely not 鈥減ublicly available.鈥
    • Government or other institutional records where public access is provided on request.
    • Information/biospecimens from a commercial entity available to anyone on request for a fee.
  • A researcher is given two datasets that contain private, identifiable information. The researcher uses the identifiers to merge the two datasets but strips the resulting (merged) data of identifiers immediately after the merge and before conducting data analysis. The resulting data used for the analysis is completely de-identified with no link to identifiers.
  • A study involving secondary research of audio archives in a public library.
  • A study involving review of national census data that contains zip codes.
  • A study involving the analysis of public officials鈥 leaked emails currently available via Wikileaks.
  • An analysis of biospecimens from an IRB-approved biorepository.

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