UD IRB Guidelines for Applications for: Registrations of exempt research, Expedited IRB review, Full IRB review

Members of the IRB Gilbert Garza, Associate Professor, Psychology, IRB Chair Stephen Slaughter, Associate Professor, Chair of Biology Laura Serviere-Munoz, Assistant Professor, COB Erin Freeman, Assistant Professor, Psychology Alternate Members: Amy Fisher Smith, Associate Professor, Psychology Sally Hicks, Professor, Chair of Phsyics

UD policies seek: To assure the safety and welfare of human research participants. To assure such privacy as may be reasonably expected by those who are survey participants or otherwise subjects of observation. Do not disclose data by which the identity of a participant may be discovered – unless consent was given) To secure confidentiality or anonymity and other rights of participants. Keep records secure for seven years (i.e.) Anonymity is preferred: No way to identify the participant Confidentiality: Steps have to be taken to protect the participants’ identities IRB 3

U.S. Departments and agencies involved in the welfare of human research participants The U.S. Department of Health and Human Services (HHS) houses : OHRP: Office for Human Research Protections Provides leadership for research conducted or supported by the HHS OHRP provides clarification, guidance, educational programs NIH: National Institute of Health NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life…] As a public service, NIH offers a free tutorial on Protecting Human Research Participants that institutions may elect to use to fulfill requirement for education in the protection of human subjects. (U.D. uses this tutorial)Protecting Human Research Participants IRB 4

Who needs to receive required education on the protection of human subjects? Individuals who will be involved in the design or conduct of human subjects research must fulfill the education requirement. These individuals are considered to be "Key Personnel" on research involving human subjects. This includes the Principal Investigator(s), all individuals responsible for the design or conduct of the study, and those individuals identified as key personnel of consortium participants or alternate performance sites. Human subjects research is any research or clinical investigation that involves human subjects – living human beings.

Exempt Registration There are six categories of research defined by 45 CFR (b), to be exempt from review: 1.Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 2.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 human subjects can be identified, directly or through identifiers linked to the subjects; and b. 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. 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 under paragraph (b)(2) of this section, if: a. the human subjects are elected or appointed public officials or candidates for public office; or b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

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. 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: a. public benefit or service programs; b. procedures for obtaining benefits or services under those programs; c. possible changes in or alternatives to those programs or procedures; or 1 of 3. d. possible changes in methods or levels of payment for benefits or services under those programs. 6.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 Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. Exempt Registration

Applications for Exempt Research should identify which of the six exempt cases describes their project. Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, researchers performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints. For this reason, investigators for any research involving human subjects must show evidence of completion of NIH humans subjects training ( within the last 3 years. The application to register research as exempt can be found at All exempt human subjects research must be registered with the IRB PRIOR TO the conduct of this research.

When Research is not Exempt from Review According to the NIH, human subjects research is not exempt when: You are collecting data by interacting or intervening with living people. AND Any of the investigators or collaborators listed in the application can identify the subjects through coded private information or specimens, or the data are recorded in such a way that participants can be identified (such as audio or video recording, photographic records).

Additionally, research does not qualify for IRB exemption if the research includes any of the the following: 1. Prisoners 2. Pregnant women 3. In vitro fertilization 4. Deception 5. Fetuses 6. Decisionally impaired 7. The use of school records of identifiable students or interviewing instructors about specific students 8. Survey or interview procedures with children (participants under the age of 18 years) 9. Observation of public behavior when the investigator(s) participates in the activities being observed 10. Data collected that includes protected health or medical information when there is a direct or indirect link that would identify the participant 11. Sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior or use of alcohol When Research is not Exempt from Review

Expedited Review Research not exempt from review may be eligible for expedited review if it poses no more than minimal risk to human subjects. Minimal Risk generally means that the probability and magnitude of physical or psychological harm anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life, or in routine medical, dental, or psychological examinations.

Expedited Review Applications for expedited review should include Provisions for obtaining informed consent, Provisions for storing and destroying data, protecting identities of participants, Any survey instrument, interview or focus group protocols or other data recording documentation forms to be used, Documentation of all investigators' recent (less than 3 years) completion of NIH humans subjects training. The application for expedited IRB review can be found at Prior IRB approval is required for all non- exempt research.

Full IRB review Full review of research proposals by the IRB is indicated when any of either of the following is true: Participation in the study exposes participants to more than minimal risk, Participation in the study involves deception of participants.

IRB full review Applications for full review should include Provisions for obtaining informed consent, Provisions for storing and destroying data, protecting identities of participants, Any survey instrument, interview or focus group protocols or other data recording documentation forms to be used, An assessment of the relationship between the known or suspected risk of participating to the value of the knowledge to be produced by the study, Detailed protocol of the researchers' steps to prevent, mitigate, or remediate any risk that might be incurred by participants, Documentation of all investigators' recent (less than 3 years) completion of NIH humans subjects training. Investigators whose research may call for full review should contact the Chair of the IRB.

Questions about the level of review or eligibility for exempt registration for your research should be directed to the chair of the IRB. Gilbert Garza x5366