conducting exempt research an overview of human subjects protections issues and the review process...
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Conducting Exempt Research
An Overview of Human Subjects Protections Issues and the Review Process at ASU
Office of Research Integrity and AssuranceInstitutional Review Board
Overview• Definitions• Process at ASU• Applying for Exempt Research• Contact Information
What is Human Subjects Research?
Research “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”
Human Subject “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information”
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102
Institutional Review Boards (IRB)• IRBs were instituted in direct response to 20th century
research abuses that occurred such as:
– Nazi War Crimes of World War II
– Tuskegee Syphilis study which was conducted between 1932 and 1972 by the US Public Health Services on black men in Alabama
IRB Role
• Assess the ethics of the proposed research
• Promote fully informed and voluntary participation by participants throughout the study
• Maximize participant safety once someone enrolls in the study
IRB Oversight
• In the United States, IRBs are governed by Federal Regulations. These are the minimum standards for protection of participants.– Department of Health and Human Services (DHHS)– Food and Drug Administration (FDA)
• State regulations and local policies apply• ASU has institutional policies for the protection of human
subjects participating in research– At ASU, the IRB is administered through the Office of Research
Integrity and Assurance (ORIA)
ASU Human Subjects Review
All Human Subjects Research must be reviewed & approved prior to data collection
3 Types of Review
• Exempt Studies (the focus of this presentation)• Expedited Review• Full Board
Review time depends upon the type of study! Exempt studies take approximately 1-2 weeks from receipt of study.
What does Exempt mean?
• For Institutional Review Board (IRB) submissions, exempt refers to 6 categories of low risk research
• The ASU IRB is responsible for determining that the proposed research meets criteria for exemption allowed by Federal Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102
Summary of Exempt ResearchCategory 1:
• Research conducted in established or commonly accepted educational settings, involving normal educational practices (i) research on regular and special education instructional strategies, or (ii) research on effectiveness of or comparison among instructional techniques, curricula, or classroom management methods.
Summary of Exempt ResearchCategory 2:
• Research involving use of educational tests, 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 subjects; and (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.
Summary of Exempt ResearchCategory 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 if: (i) human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that confidentiality of personally identifiable information will be maintained throughout research and thereafter
Category 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.
Summary of Exempt ResearchCategory 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:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures;
or (iv) possible changes in methods or levels of payment for benefits or
services under those programs.
Summary of Exempt ResearchCategory 6:
• Taste and food quality evaluation and consumer acceptance studies(i) if wholesome foods without additives are consumed or (ii) 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 level found to be safe, by the
FDA or approved by the EPA or the Food Safety and Inspection Service of the USDA.
How to Apply• The Principal Investigator (PI) is a faculty or staff member
who observes the project with the following responsibilities:– Submission of the application– Oversees the conduct of the research– Student researchers cannot serve as the PI
• Co-Investigator (CO-I) is anyone who has responsibility for the project’s design, implementation, data collection, data analysis, or who has contact with study participants.
How to Apply• You will use ERA-IRB to submit your application.• You can have all your materials prepared and then load
them into the system.• The software will automatically guide you through the
process of completing the application forms based on the information you enter.
• For more information about using ERA-IRB, see http://researchintegrity.asu.edu/humans
Other Materials• Due to the low-risk nature of exempt studies, a signed
consent form is generally not necessary. Instead the research team should develop and submit the following:– Short Form Consent Form. The templates can be found at:
http://researchintegrity.asu.edu/humans/forms
How will the data be used?Red terms are research & black terms are situation dependent:• Dissertation• Publication/journal article• Thesis• Undergraduate honors project• Results released to participants/parents• Results released to employer or school• Results released to agency or organization• Conferences/presentations• Other:
Other uses of data: Classroom Research• Classroom projects that involve systematic collection of data
and for which the objective or design is to develop or contribute to generalizable knowledge are considered research. In other words, if a student plans to use the data outside of the classroom, then the project is considered research. This type of project should be reviewed by the IRB.
• Classroom projects that are designed with the objective of providing students with training about and experience with research methods are not considered research. In these cases, students will not use the data outside of the classroom. This type of project does not require IRB review.
Category 1: Terms and Examples
• “Commonly accepted” programs include preschools, elementary schools, middle schools, high schools, and colleges
• Evaluation of 2 methods of a 4th grade instruction commonly used in a school district
• A study of 2 case management methods for mainstreaming handicapped elementary school students
Research with minors who are under 18 can be exempt under category 1
Category 2: Examples
• Surveys of adults who are over 18 on attitudes about shopping. Survey can be done in person or online.
• Survey asking Likert scale questions in which respondents rate qualities that they feel are important in leaders.
• Interviews with individuals who are over 18 about attitudes about global warming. In this case individuals can remain anonymous or be quoted directly.
Caveats
• The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
• The responses of participants can be “identifiable” so long as the results would not place them at risk for criminal or civil liability.
When is Survey Research Not Exempt?
• Study involves children under age 18 and the research does not fall under Exempt Category 1
• Sensitive topics are used and results are not anonymous. For example, there is a longitudinal study with a master list in which participants are asked about illegal drug use
• Prisoners are part of study population
Category 3: Examples
• Survey research on attitudes about social service policies of standing state governors
• Observation research on public presentations by city council representatives at neighborhood meetings
Category 4: Examples
• Research that uses publically available data from websites such as the National Center for Education Statistics or Centers for Disease Control and Prevention
• Data from school records that is given to the research team without any identifiers or way to identify subjects (AIMS data for example)
Categories 5 and 6: Examples
• Category 5 is rarely seen the university setting
• For Category 6, an example would be a study of how individuals age and their perception of sugar. Individuals of different ages would be asked to consume sugar and respond to questions
Human Subjects Training
ALL researchers must document training. This includes facultyand student researchers.
• Training is valid for 3 years
• CITI Training is required: http://www.citi.org
• Contact the IRB if you have taken other trainings to see if they will be accepted
Other Common Questions
• Research with minors can be exempt under category 1
• Research with prisoners cannot be exempt
• Research with Native American participants can be exempt. If the study will occur on Tribal Land, Tribal permission will be required before exemption can be granted at ASU
Other Common Questions
• There is no expiration date for exempt studies at ASU
• Modifications do not have to be submitted unless the exempt status would change. For example, the research was an anonymous survey of individuals 18-25 and would now include 16-17 year olds
What if the study does not meet criteria for exemption?
• If the proposed research does not meet criteria for exemption, then it can be reviewed under criteria for minimal risk research under expedited criteria or considered by the committee at a convened meeting.
• Using ERA-IRB, submit an application for review by the IRB.• Please contact the IRB if you have questions regarding
whether your research is Social Behavioral or Bioscience
Contact Information
ORIA staff are available to answer questions and assist you.• Susan Metosky
– [email protected] (480) 727-0871
• Tiffany Dunning – [email protected] (480) 639-7396
• David Marin – [email protected] (480) 965-4796
• Debra Murphy, Director – [email protected] (480) 965-2179