Search

Human Subjects

Policies & Guidance

Exempt Studies

The Common Rule, 45 CFR 46, designates six categories of research as exempt.  In addition to the federal exempt categories, the IU Standard Operating Procedures (SOP) for Research Involving Human Subjects Investigators allows non-federally funded, non-federally regulated research in two additional categories to be considered exempt.  Researchers should not interpret “exempt” to mean that review of the research is not required.  As recommended by the Office for Human Research Protections, IU policy requires that all human subjects research, including exempt research, must be submitted to the IU Human Subjects Office (HSO) for determination of exemption or IRB approval.

Requirements for all Exempt Research

To be eligible for exempt review, all research activities must fall into one or more of the exempt categories described in the Common Rule or the exempt flex categories described in the IU SOP on Exemptions.  These categories are described in detail below.  Additionally, all exempt research must meet the following requirements:

  • Research activities must present no greater than minimal risk to subjects.
  • Research subjects cannot include prisoners.
  • If the research is subject to VA research regulations, subjects cannot include pregnant women.
  • Research must be consistent with the ethical principles described in the Belmont Report, specifically, respect for persons, beneficence, and justice.
  • If identifiable information will be recorded, an adequate plan for protection of confidentiality of data must be in place.

Additional restrictions apply to certain exempt categories as described below.

Exempt Categories pursuant to the Common Rule

Category 1:  Research on Educational Practices

Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:

  • Research on regular and special education instructional strategies; or
  • Research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.

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:  Use of Educational Tests, Survey or Interview Procedures, or Observation of Public Behavior

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
Exclusions: 

  1. 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.
  2. Research involving interaction by the researcher 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 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.

Example 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 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 records the information she needs for her research, so that the data being analyzed for the research cannot be traced back to individual subjects.

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;
  • procedures for obtaining benefits or services under those programs;
  • possible changes in or alternatives to those programs or procedures; or
  • possible changes in methods or levels or payment for benefits or services under those 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;
  • food is consumed that contains a food ingredient at or below the level and for use found to be safe by the Food and Drug Administration (FDA) or approved by the Environmental Protection Agency (EPA), or the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA); or
  • food is consumed that contains an agricultural chemical or environmental contaminant at or below the level found to be safe by the FDA or approved by the EPA or the FSIS of the USDA.

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.

Exempt Flex Categories pursuant to the IU SOPs

If the research does not fit into one or more of the six exempt categories described above, the research may still qualify for exempt review pursuant to the flexibility option described in the IU SOPs.  For additional information regarding flexibility, see the Guidance on Regulatory Flexibility.  To be eligible for review under one or more exempt flex categories, the research must meet the following additional requirements:

  • Not supported directly or indirectly by federal funds,
  • Not subject to FDA regulations,
  • Not subject to VA research regulations, and
  • Not subject to HIPAA.

The exempt flex categories described below are based on the federal expedited categories 6 and 7.  Generally, research that would be eligible for expedited category 6 and/or 7 review is eligible for exempt review provided it meets the requirements listed herein.

Category 6 Flex:  Research Involving Recordings

Research that involves collection of data from voice, video, digital, or image recordings made for research purposes.

Category 7 Flex:  Research on Individual or Group Characteristics or Behavior

Research on individual or group characteristics or behavior (including but not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Exclusions:

  1. Research cannot be exempt under Category 7 Flex 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 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, insurability, or reputation. 
  2. Research involving interaction with children under the age of 14.
  3. Research employing deception.  See the Guidance on Deception or Incomplete Disclosure  for additional information.

In developing the exempt flex policies, HSO carefully considered whether research involving interaction with children may be appropriate for exempt review.  Current research regarding adolescent capacity to consent indicates that the decision-making skills relevant for providing informed consent to participate in research develop during adolescence.  For adolescents ages 14 and older, understanding of research and the cognitive ability to make treatment decisions are similar to the abilities of adults.  Therefore, for minimal risk research meeting the Category 7 Flex criteria, interaction between researchers and subjects ages 14 and older is permitted.  However, HSO may still require parental notification and/or permission for the adolescent to participate depending on the nature of the research.

Respect for Persons and Agreement to Participate in the Research

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.  HSO recommends that researchers 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 minimum, the following information should be provided to subjects when researchers will interact with subjects for research purposes:

  • That subjects are being asked to participate in research;
  • A clear description of the study procedures;
  • A statement regarding any potential risks or benefits of participation;
  • A statement that participation is voluntary; and
  • 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 is provided on the Forms & Templates  page 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.

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 an IRB.  IRB approval of waivers and alterations of authorization for exempt research are documented via the Grant Exemption correspondence generated by KC IRB and the KC IRB questionnaire that is part of the exempt application.  The KC IRB correspondence identifies the IRB granting the waiver, the date upon which the waiver or alteration was granted, and includes the signature of the IRB Chair for the IRB that granted the waiver of alteration.  Additionally, the correspondence includes specific statements of the regulatory waiver criteria that were determined to have been met.  The KC IRB questionnaire, which is considered part of the approval, includes the description of the PHI to be used or disclosed pursuant to the waiver or alteration.  The KC IRB history lists the specific IRB member who served as reviewer and granted the exemption and waiver or alteration of authorization.

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 do require review by HSO prior to implementation of the modification. 
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 approved 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.
  • Change in funding source.
  • 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 you will receive or record.  For example, your exempt application states that you will not collect names with the surveys, but you now want to, or you now want to record identifiable data from an existing dataset.
  • Changes to the risks involved in the study.
  • 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.   

Additional Considerations for Most Commonly Used Exempt Categories

Category 1:

  • 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.
  • Research activities that qualify for exemption under this category may also be subject to other regulatory requirements under the Family Educational Rights and Privacy Act (FERPA) and/or the Protection of Pupil Rights Amendment (PPRA).  Contact IU Human Subjects Office staff with questions regarding the applicability of FERPA or PPRA to your research.
  • 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.
  • 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 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:
    • Will 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.
      • If you do not normally have access to any of the above information, you may obtain it only after the custodian of the records de-identifies the data.  If you do not normally have access and you want to collect identifiable data or data linked to identifiers for which you will have access to the code key, the research does not qualify for exemption. 
      • FERPA states that school officials, including teachers, can access identified records so long as there is legitimate educational interest to be determined by that agency/institution.  IU’s policy is that the records custodian makes this determination.
    • 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.

Category 2:

  • Survey procedures refer to the act of gathering data on attitudes, impressions, opinions, satisfaction, etc., by polling a section of the population.
  • Interview procedures refer to a meeting at which people talk to each other in order to ask questions and get information.
  • Public behavior refers to behavior in which the subject does not have a reasonable expectation of privacy, such as in a public plaza or park, a street, or a building lobby.  If subjects have a reasonable expectation of privacy at the location where the researcher is conducting the observation, the project may not be considered exempt.
  • Audio and/or video recording is acceptable for purposes of data collection/transcription.  If recording will be used, protection procedures specific to storage and use of the recording must be described to demonstrate an adequate plan for protection of subject confidentiality.

Category 4:

  • The data or specimens to be used in the research must exist at the time the research is proposed.  This category does not apply to the prospective collection of data or specimens.
  • The data or specimens to be used in the research must have been collected for a purpose other than use in the current study (e.g., collected for clinical purposes or collected in an earlier research study).
  • Access to identifiable private information, including PHI, is permitted under Category 4 if the data is recorded in such a way that the information can no longer be connected to the identity of the subjects.  This means that the research record cannot include direct identifiers (names, Social Security numbers, addresses, phone numbers, etc.) or indirect identifiers (codes or pseudonyms that are linked to the subject’s identity) unless the information is publicly available.

Category 6:

  • 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 exempt status.

Additional Considerations for Research Conducted at External Sites

When research, including recruitment, is to be conducted at an institution, organization, company, or other site not affiliated with IU, such as public or private schools or businesses, keep in mind the following:

  • The PI must obtain and document permission from the appropriate authority to allow the conduct of the research or recruitment at the external site.  This documentation must be made available to the HSO upon request.
  • The PI is responsible for complying with IU policies and procedures pertaining to the conduct of exempt research as well as with any policies and procedures of the institution/organizations where the research is being conducted.
  • When research is to be conducted in a language other than English, the PI must provide subjects with accurately translated study documents (e.g., Study Information Sheet, recruitment materials, surveys).  Only the English versions of these documents should be submitted in KC IRB for review. However, translations must be made available to the HSO upon request.
RASD | Browser Recommendations | Webmaster | IU Emergency System | Office Information | Site Map