Human Subjects
The term human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains individually identifiable, private information.
Intervention includes both physical procedures (e.g., venipuncture) by which data are gathered and manipulations of the subject (e.g., by deception) or the subject's environment (e.g., by introducing extreme heat) that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about a subject that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also refers to information that has been provided for specific purposes by an individual with the reasonable expectation that it will not be made public (for example, a medical record). Information is individually identifiable if the identity of the subject is associated with the information or may be readily ascertained by the investigator.
USI's definition of Human Subject Research.
Research For IRB purposes
Research is defined as a systematic investigation, inquiry, or analysis—such as scholarly or critical study or inquiry or scientific investigation, development, testing, or evaluation—designed to develop or contribute to generalizable knowledge. Research includes activities that aim to test a hypothesis, discover or collate facts, principles, or effects, reach new conclusions, or reexamine information by the critical study of a subject or by a course of scientific inquiry. Examples of human subjects research include:
a. Studies in which a substance or stimulus is administered to a subject, or responses or states are measured;
b. Studies that involve changes in the subject's physical or psychological state or environment, or changes in diet;
c. Interviews, surveys, tests, inquiries, and observations designed to elicit or obtain nonpublic information; and
d. Studies of existing records where the identity of the subjects is known or could be readily ascertained by the investigator.
e. Public Benefit/Service Programs 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; or (b) procedures for obtaining benefits or services under those programs; or (c) possible changes in or alternatives to these programs or procedures.
Activities meeting this definition constitute research for purposes of human subjects policies, whether or not they are considered research for other purposes.
If results are not disseminated (published, presented, or shared) externally, the term research is not intended to apply to data acquisition resulting from:
a. Routine course, workshop, or curriculum development activities using accepted educational practices sponsored by the University of Southern Indiana, including evaluations to determine student or participant satisfaction, attitude change, or knowledge gained during the educational experience; or
b. Aid or services provided by professionals to their clients that are consistent with accepted and established practice, and intended only to meet the clients' own personal needs.
If results from these activities are disseminated externally, the activities constitute human subjects research and must receive IRB approval prior to the beginning of the research.
Some examples of activities which are not subject to IRB review:
- Activities involving individuals intended solely for internal use, performed to improve services or develop new services or programs, (e.g., satisfaction surveys) without plans for presentation or publication performed as a part of organizational operations
- Biographies
- Oral histories that are designed solely to create a record of specific historical events
- Service or course evaluations, unless they can be generalized to other individuals
- Services, courses, or concepts where it is not the intention to share the results beyond the USI community.
For more information, visit the Research That May Not Require Review page.
Review Categories & Other Definitions
Exempt Review Categories
Exempt Category 1– Research in Educational Settings
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods. (45 CFR §46.101[b][1])
Exempt Category 2 – Tests, Surveys, Interviews, Observation of Public Behavior
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 the human participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation. (45 CFR §46.101[b][2])
(NOTE: Survey and interview research involving children cannot be designated as Exempt from Review. Observation of public behavior research involving children, however, can be designated as Exempt from Review only when the investigator does not participate in the activities being observed.)
Exempt Category 3 – Tests, Surveys, Interviews, Observation of Public Behavior
Part 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 above if: (a) the human participants are elected or appointed public officials or candidates for public office; or (b) federal statute requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. (45 CFR §46.101[b][3])
Exempt Category 4 – Use of Existing Records
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 participants. (45 CFR §46.101[b][4])
Exempt Category 5 – Public Benefit/Service Programs
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 alternatives to these programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs. (45 CFR §46.101[b][5])
Exempt Category 6 – Consumer Acceptance
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, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environment Protection Agency or the Food Safety and Inspection Service of the U. S. Department of Agriculture. (45 CFR §46.101[b][6]
Revised 4/12/2012
Expedited Review Categories
Expedited Category 1 - Drugs or devices not needing investigational new drug or device exemptions.
Expedited Category 2 - Venipuncture blood from ambulatory non-pregnant adults (<2x/wk, <450cc in 8 wks).
Expedited Category 3 - Collection of biological specimens by noninvasive means (hair, excreta, nail clippings, etc.).
Expedited Category 4 - Recording data from adults by non-invasive clinical procedures (e.g., weight, height, eye-color) and moderate exercise by healthy volunteers.
Expedited Category 5 - Study of existing data, documents, records, or specimens.
Expedited Category 6 - Study of voice, video, digital, or image recordings as the focal point of the research protocol (e.g., investigation of speech defects). Please note any type of recording solely for the purpose of data documentation must have the appropriate safeguards in place to prevent any potential harm that may be a result of a breach in confidentiality. When the appropriate safeguards are present, research using this type of data documentation will fall under the exempt review category.
Expedited Category 7 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; (ii) 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; (iii.) the human subjects are elected or appointed public officials or candidates for public office; or (iv.) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
VULNERABLE POPULATIONS
a. Children – All studies involving children which are not otherwise exempt require IRB review in accordance with the provisions of 45 CFR 46 subpart D, Additional Protections for Children Involved as Subjects in Research.
i. For children between 7 to 18 years, documented assent of the child and informed consent of the parent or guardian are required, and research involving greater than minimal risk must present the prospect of direct benefit to the individual subjects.
ii. Research involving children, although designated a “vulnerable population,” can be classified as Exempt from review under most conditions. All exempt categories apply to research with children except parts of category 2: observations of public behavior involving children may be exempt when the investigator(s) do not participate in the activities being observed. However, research with children involving survey or interview procedures may not be exempt from review.
iii. Research involving children, although designated a “vulnerable population,” can be classified as Expedited Review if the study fulfills the general criteria. iv. Contact the IRB Administrative Office for specifics, or view the Office of Human Research Protections’ (OHRP) website for additional information.
b. Pregnant women or fetuses - Research involving pregnant women or fetuses which are not otherwise exempt require IRB review in accordance with the provisions of 45 CFR 46 subpart B, Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research.
i. Research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates, although designated a “vulnerable population,” can be classified as Exempt from review when the study meets the criteria of one or more of the categories.
ii. Research involving pregnant women or fetuses are restricted. Specific conditions concerning assessing potential risks and obtaining informed consent apply. Contact the IRB Administrative Office for restriction specifics or refer to the Office of Human Research Protections’ (OHRP) website for more information.
c. Prisoners – Research involving prisoners requires IRB review in accordance with the provisions of 45 CFR 46 Subpart C, Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects.
i. When no more than minimal risk and no more than inconvenience to the subjects, investigators may study the possible causes, effects, and processes of incarceration, and of criminal behavior; or study prisons as institutional structures or prisoners as incarcerated persons.
ii. Investigators may conduct research on practices with the intent and reasonable probability of improving the health or well-being of the subject.
iii. Studies may not be approved which require assignment of prisoners to control groups which may not benefit from the research.
iv. Research on conditions particularly affecting prisoners as a class requires additional consultation with appropriate experts including experts in penology, medicine, and ethics. Updated 5/1/2012
v. Contact the IRB Administrative Office for specifics, or view the Office of Human Research Protections’ (OHRP) website for additional information.
PROTECTED POPULATIONS
Representative from a minority group - Subject selection is from individuals considered to be representative of a minority group. A minority group is any category of people that is set apart by physical or cultural difference and socially disadvantaged as a result. Minority group does not refer to a numerical minority.
Institutionalized People: Informed consent is problematic and the subjects are vulnerable. Contact the IRB Administrative Office for restriction specifics.
A. Definition of Secondary Data
Secondary data is defined as “data that has already been collected for either research or non-research purposes and has not been proposed to an institutional official or the IRB for review.” USI’s IRB has determined the following categories as secondary data:
- De-identified publicly available data (Exempt);
- De-identified non-publicly available data (Exempt);
- Publicly available data with private identifiable information or non-publicly available data with private identifiable information where researchers will not record individual identifiers (Exempt);
- Non-publicly available data containing private identifiable information (Expedited or Convened). Because the information accessed in these forms of analysis varies, the USI IRB has instituted review procedures that reflect differences among data sources. USI Investigators conducting research involving secondary data sources are encouraged to review the qualifiers for each process (see section C.) in order to prepare the appropriate application form.
B. Secondary Data Policy Stated
Secondary data can be used in IRB protocols but is subject to the regulations in 45 CFR 46. All USI investigators must complete an IRB application and submit it electronically through IRBNet for review by the IRB committee. All questions can be directed to the USI Office of Sponsored Projects and Research Administration at rcr@usi.edu.
C. Policy Qualified
1. If research only involves the study of existing data, documents, records, pathological specimens, or diagnostic specimens, and if data is publicly available when collected, follow exempt review process using form A.
2. If research only involves the study of existing data, documents, records, pathological specimens, or diagnostic specimens, that is not publicly available, and is de-identified, follow exempt review process using form A.
3. If research only involves the study of existing data, documents, records, pathological specimens , or diagnostic specimens, that is not publicly available, and if information will be recorded by the investigator in such a way that the subjects can be identified, follow expedited or full board review process using form B.
4. If research involves more than the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, follow appropriate review type for the data and for the type of additional research activities.
5. If research has previously been approved and requires a minor change within the one year period following approval, fill out modification form C.
6. If research has not been previously approved and presents no more than minimal risk to human subjects, follow exempt review process using form A.
7. If research has not been previously approved and presents more than minimal risk to human subjects, follow expedited or full board review process using form B.
8. If research has not been previously approved, presents no more than minimal risk to participants, and identification of subjects could put them at risk of criminal or civil liability or be socially or economically damaging (with no measures to make these risks no more than minimal), follow expedited or full board review process using form B.