Exempt Studies

Subject agreement to participate in exempt research

Exempt research is not subject to the formal informed consent requirements in the Common Rule; however, the Belmont Report ethical principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether to participate in research. For this reason, if researchers will be interacting with subjects, subjects should be informed of the research and their agreement to participate should be obtained. In these situations, researchers should, at a minimum, provide subjects with the information listed below to enable subjects to make a voluntary decision whether to participate in the research. In some cases, researchers may find it necessary or appropriate to provide more information.

At a minimum, the following information should be provided:

  • That subjects are being asked to participate in research;
  • A description of the study procedures;
  • A statement regarding any potential risks or benefits of participation;
  • A statement that participation is voluntary;
  • The name, affiliation, and contact information of the researcher(s).

Depending on the complexity of the study, the familiarity of the potential subjects with research, and the forum for interaction with subjects, this information may be presented in a number of different ways. A Study Information Sheet template specific to Exempt research is available that can be used for this purpose. For survey research, a short written statement incorporated into the beginning of a written survey may be more appropriate. In other situations, a verbal discussion covering the elements above may be sufficient. If you have questions regarding how information regarding the research should be conveyed to potential subjects, please contact HSO staff for assistance.

Amendments to Exempt Research

Minor modifications to exempt studies do not require HSO review and approval unless they may change the study’s eligibility for exemption. Modifications that have the potential to change the nature of the research and, therefore, the study’s eligibility for exemption (“substantive modifications”) do require review by HSO. Substantive modifications must be submitted to HSO for review prior to their implementation. To request review, submit an Amendment to the existing study in KC IRB.

Examples of minor modifications that can be implemented without review:

  • Addition or removal of study personnel other than the PI.
  • Minor revisions to recruitment materials and methods. For example, a change to the phone number, or the addition of a newspaper ad when using similar language as an already reviewed flyer.
  • Minor revisions to survey, interview, or focus group instruments that do not fall outside the scope of the original approved instruments. For example, wordsmithing, addition of clarifying questions, addition of very similar questions to those previously approved, or deletion of questions.

Examples of substantive modifications that require review:

  • Change in PI.
  • Addition or elimination of federal funding.
  • Change to study purpose or procedures. For example, adding a survey on a different topic than previously approved or collection of data falling outside the parameters of the data collection previously approved.
  • Changes to study population targeted for recruitment. For example, adding a new population or substantively revising the inclusion/exclusion criteria for the current population.
  • Changes to the identifiability of the research data received or recorded, or changes in the way research data will be stored. For example, the exempt application states that surveys with names will not be collected, but you now want to collect the names, or you now want to record identifiable data from an existing dataset.
  • Changes to the risks involved in the study.

Examples and Considerations for Available Exempt Categories

Category 1: Research on educational practices which is not likely to adversely impact students’ opportunity to learn required educational content or the assessment of instructors who provide instruction

Considerations:

  • Commonly accepted educational settings include but are not limited to K-12 schools, college classrooms and/or learning management systems, residency programs, teaching hospitals, special education programs, after-school programs, preschools, vocational schools, alternative education programs, and other sites where educational activities regularly occur.
    • If research will be conducted outside of these settings, researchers should justify in their application why the setting is believed to be a commonly accepted educational setting.
  • Normal educational practices are activities that would occur regardless of whether the research is conducted.
    • Research involving radically new or innovative educational practices may not qualify for exemption. If unusual methods are to be used, researchers should justify why the practice is considered a normal educational practice. One way to do this is to provide a letter from an authority of the school/institution where the research will be conducted attesting to the acceptability and use of the procedures in the normal conduct of education activities at the school/institution.
  • If not all students will be participating in the educational practice, you must explain what the students who will not be participating will be doing instead. It is important that the study is designed in such a way that it does not penalize or have potential for stigma for students who will not be participating.
  • Subject agreement to participate in the research should be obtained when the research would change the subjects’ experience of the course. Notification in the syllabus is acceptable as long as the information also provides students with an opportunity and mechanism to opt out of the research.
  • If the study involves research subjects under the age of 18, parental notification and student assent may be needed. Signed parental permission may not be required, but the IU HSO typically recommends that researchers notify parents of the research, allow parents to opt-out if they do not want their child to participate, and obtain agreement to participate from the child subject.
  • The following should be addressed in the application:
    • If the research activities occur during class time or outside of class time.
    • If implementing a novel educational method, describe how it differs from the standard method.
    • If reviewing and/or collecting student grades and/or standardized test scores, describe what grades or scores will be reviewed and/or collected.
    • If observing and/or recording data (audio/video/handwritten) on teachers and/or students, describe the activity.
    • If reviewing coursework, describe what coursework will be reviewed, if it will be identifiable, and how subjects’ identities will be protected.
    • State if the educational activity is being conducted solely for the research study or if the educational activity occurs regardless of whether the research is conducted.
  • If your research requires access to student records protected by FERPA, please refer to the HSO Guidance on FERPA. Please also see HSO Guidance on Students as Subjects.

Examples of research that may qualify for exemption under Category 1:

  • 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 normal classroom practices.
  • A study evaluating the effectiveness of an interactive anatomy/physiology DVD used to help medical students study for exams.
  • A study evaluating the effects of a health literacy curriculum on first-year physician assistant students.
  • 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.

Category 2: Research that includes only interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior

Research cannot be exempt under Category 2 if both of the following are true:

  • Information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects AND
  • Any disclosure of the subject’s responses outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, or reputation.

Research involving interaction by the research with children (i.e., subjects under 18 years of age) cannot be exempt under Category 2.

Examples of research that may qualify for exemption under Category 2:

  • A researcher asks patients who have diabetes to participate in a focus group about their exercise habits.
  • An investigator reviews publicly available Twitter posts that include the term “smoking”. The investigator evaluates these posts to determine what type of information Twitter users are sharing about this topic.
  • A survey of women at a local hospital regarding their knowledge of and attitudes toward the Human Papillomavirus (HPV) vaccine.
  • A research project interviewing adult subjects about the influence of religion on their health.
  • A researcher asks nurses from several institutions to complete three online surveys about a new statewide mandate. The surveys include the nurses’ email addresses so the surveys can be linked. However, the researcher will not share the email addresses with anyone outside the study team and will destroy the link after completing data collection. Note: Because the responses are linked, the study would not qualify for exemption if the survey responses may put the nurses' employment at risk.

Category 2 Flex: Non-federally funded, non-federally regulated research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior

Considerations:

  • This exemption category is specifically for situations in which non-federally funded, non-federally regulated research does not qualify for exemption under Category 2 because the data will be recorded in an identified manner, and disclosure of that data could place the subjects at some risk.
  • This category requires a limited IRB review to determine that appropriate privacy and confidentiality safeguards are in place.

Category 3: Use of Educational Tests, Survey or Interview Procedures, or Observation of Public Behavior for Research not Exempt under Category 2

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 Category 2 but meets either of the following:

  • The subjects are elected or appointed public officials or candidates for public office; OR
  • Federal law requires without exception that confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Examples of research that may qualify for exemption under Category 3:

  • A survey administered to town mayors within a county that contains questions that might expose information the public might not support. The PI can report the data, identifying the mayors who participated in the study and even identifying how certain mayors answered specific questions, and still qualify for exempt review. Public officials or candidates running for public office are not protected by the same high privacy standard as civilians under Category 2.

Category 3 Flex: Non-federally funded, non-federally regulated research involving benign behavioral interventions in conjunction with the collection of information from an adult subject

Considerations:

  • This category allows researchers to include interventions with subjects in their exempt studies, which is not allowed under Category 2 or 2 Flex.
  • Benign Behavioral Interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
  • If the information is recorded so that subjects can be identified, and disclosure of the subjects’ responses could place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation, the study may still be exempt but will be reviewed by an IRB member who will determine there are adequate provisions to protect subjects’ privacy and confidentiality.
  • Subject agreement to participate in the research must be obtained.
  • Studies involving children cannot qualify for this exemption.

Examples of research that may qualify for exemption under Category 3 Flex:

  • Groups of subjects are given tests to complete under varying light or noise levels
  • Subjects are shown different emotionally charged videos and then asked survey questions about political or religious beliefs
  • Subjects are shown a series of images on a computer screen, asked to push a button when they appear, and their reaction time is measured

Category 4: Collection of Existing Data

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if:

  • These source(s) are publicly available; or
  • The information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.

Examples of research that may qualify for exemption under Category 4:

  • A research study of treatment outcomes for a drug that involves the review of patient charts at an IU-affiliated hospital. The researcher records patient age, sex, diagnosis, and treatment outcome in such a way that the information cannot be linked back to the patient.
  • A graduate student has access to identifiable data from a study previously conducted by her faculty advisor, and the information she needs for her research is recorded in such a way that the data being analyzed for the research cannot be traced back to individual subjects (i.e., in a de-identified fashion).

Category 4 Flex: Non-federally funded, non-federally regulated secondary research uses of identifiable private information and identifiable biospecimens

This Exemption has two sub-categories:

  • Studies which record data in a de-identified manner and so would fit into Category 4 above, except that the researcher remains open to new data or specimens that are created after the protocol submission date;
  • Chart reviews using only data protected by HIPAA.

The study need only fit into one of the sub-categories to qualify for exemption. For example, the second sub-category exempts review of medical records that are protected by HIPAA. This does not include other documents such as student records. However, a review of student records would be exempt if it fit into sub-category 1 (identifiers are not being recorded in the research record).

Considerations:

  • The date the original record is created is not relevant. These studies can include records that are created after the study is approved (e.g., prospective or retrospective).
  • If the research is a medical chart review study, no additional interactions (other than the collection and analysis of data) with subjects can be combined with this exemption (e.g., collection of medical record information under Category 4 Flex cannot be combined with collection of survey data from research subjects under Category 2).

Examples of research that may qualify for exemption under Category 4 Flex:

  • A research study of treatment outcomes for a drug that involves only the review of patient charts at an IU-affiliated hospital, where the study team collects data created after the study is approved and/or records identifiers in the research record

Category 5: Research and Demonstration Projects Studying Public Benefit Programs

Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and designed to study, evaluate, or otherwise examine public benefit or service programs.

Category 5 is limited to research on federal public benefit programs. Research on state or local public benefit programs are outside the scope of Category 5.

Category 6: Taste and Food Quality Evaluation Studies

Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed, or if amounts of additives or contaminants found in the food are at or below federally approved safety levels.

Considerations:

  • The food must be wholesome, meaning that the food ingredients have not been manipulated by the investigator.
  • Moreover, the content of the food cannot be detrimental to the health of the research subjects. If it involves plants or animals raised for food products, the level of chemical additives or environmental contaminants must be at or below the levels approved by the FDA, EPA, or USDA.
  • Studies involving the consumption of alcohol, vitamins, and other supplements do not qualify for exemption.

Examples of research that may qualify for exemption under Category 6:

  • A taste study evaluating the differences in taste of various types of apples grown nationally.
  • A taste study analyzing the effects of an additive to beef if the additive has been determined to be safe by the FDA.
  • The taste effects of a low-level environmental contaminant on a food product that has been deemed safe by the FDA and EPA.

Applicability of the Health Insurance Portability and Accountability Act (HIPAA) to Exempt Research

HIPAA applies to exempt research to the same extent it applies to expedited and full board human subjects research. See the HIPAA guidance document for additional information regarding HIPAA and its applicability to research.

In compliance with 45 CFR 164.512(i), exempt research for which a waiver or alteration of authorization is requested will be reviewed and approved by a member of the IRB, acting as Privacy Board.