The Institutional Review Board is responsible for reviewing research involving human subjects and enforcing the requirement of informed consent to assure that the rights and welfare of subjects who participate in research conducted by WSU faculty, staff and students are protected and that the University is in compliance with federal requirements (Title 45 Code of Federal Regulations, Part 46).

The IRB meets on the fourth Monday of the month. Please submit all documents to the IRB inbox at least 2 weeks before the meeting (deadline dates below) to allow time for administrative review.

**Notice – UPDATE June 2018**  The U.S. Department of Health and Human Services and 16 other federal departments and agencies have again delayed the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).  Most provisions in the revised Common Rule were originally scheduled to go into effect on January 19, 2018, this was then delayed to July 19, 2018 and is now delayed another 6 months, providing regulated entities additional time to prepare to implement these revisions. The current delay places the general compliance date of the 2018 Requirements for an additional 6-month period until January 21, 2019.

What this means for WSU investigators – There will again be a submission freeze for all new studies beginning December 20, 2018 through January 21, 2019. Amendments to currently approved projects and annual continuations will be processed during this time.  Please contact IRB@wichita.edu with any questions. Thank you for your patience during this time of transition!

 

IRB Resources & Links

Federal Regulations and Guidelines; 45 CFR 46: Protection of Human Subjects
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
http://ohsr.od.nih.gov/guidelines/belmont.html

Protecting Personal Health Information in Research-Understanding the HIPAA Privacy Rule
http://privacyruleandresearch.nih.gov/pdf/HIPAA_Privacy_Rule_Booklet.pdf

IRB FAQ

When is Review Required? 
All research and research-related activities involving human subjects must be reviewed and approved by the IRB in writing prior to initiation of a project. Review by the IRB is required whether a project is conducted by faculty members, graduate students, undergraduate students, or staff. It is required whether the project receives external funding, internal funding, or no funding.

AnchorWho Should Complete the Application?
This application should be completed by the principal investigator. If that is a student, the application must list the student's faculty sponsor as principal investigator and the student as co-principal investigator, and should be approved and signed by the named faculty sponsor.

AnchorWhat to Submit?
A scanned copy with electronic signature(s) and all supporitng materials must be sent to the IRB In-Box:   irb@wichita.edu

Supporting materials include, but are not limited to, informed consent forms, questionnaires, survey instruments, letters of approval from cooperating institutions/agencies, etc.

AnchorWhen are Full Reviews Required?
Full IRB review is required for all research posing greater than minimal risk to subjects. In addition, full review is required for all research activities involving vulnerable subject populations, including, but not limited to, pregnant women, prisoners, and psychiatric patients.

Expedited IRB review is provided for research that presents no more than minimal risk to subjects, and involves only procedures listed in one or more of the following categories:

  • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non research purposes (such as medical treatment or diagnosis);
  • Collection of data from voice, video, digital, or image recordings made for research purposes;
  • 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 research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies;
  • Clinical studies of drugs and medical devices only when a new drug application (21 CFR Part 312) is not required;
  • Clinical studies on medical devices for which an investigational device exemption application is not required or the medical device is cleared/approved for marketing;
  • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non pregnant adults who weigh at least 110 pounds
  • Collection of biological specimens for research purposes by noninvasive means, such as hair and nail clippings, teeth, excreta, and external secretions (including sweat and saliva);
  • Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves, and
  • Continuing review of research previously approved by the convened IRB.

AnchorExempted review means exempt from full IRB review, for the following categories:

  • Research involving normal educational practices;
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),survey or interview procedures or observation of public behavior, unless the obtained information is recorded in such a manner that human subjects can be identified
  • Research involving the use of educational tests (cognitive diagnostic, aptitude, achievement), survey or interview procedures, or observation of public behavior that is not exempt under the previous category if the subjects are elected or appointed public officials or candidates for public office;
  • Research involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens if these sources are publicly available, or if the information is recorded in such a manner that subjects cannot be identified, and
  • Taste and food quality evaluation and consumer acceptance studies.

AnchorWhat is Informed Consent?
Every researcher (faculty, staff, or student) at WSU must obtain the informed consent of any human subject used in research before involving that person in the research project. The investigator must ensure that the circumstances under which consent is sought will provide the subjects (or their representative) with sufficient opportunity to consider whether or not to participate. Informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", i.e. understandable to the people being asked to participate. The written presentation of information is used to document the basis for consent and for the subjects' future reference.

If the subject is a child or minor, an assent form must be signed to accompany the parent/guardian consent form.

Under certain circumstances, the use of written consent documents may be waived. All waivers must be approved by the IRB, and requests for waiver must be fully justified by the researcher when submitting an application to the IRB. Waiver of written consent procedures does not imply waiver of the researchers' responsibility to obtain consent from the subject. Wherever practicable, when a written informed consent form is waived, a cover letter should be submitted to subjects which outlines the purpose and procedures of the project including a statement indicating that completion of the survey and/or return of the questionnaire indicates consent to participate in the study.

AnchorHow long does it take to get IRB approval?
Turnaround times vary depending on the type of review required (Exempt, Expedited or Full Committee), the complexity of the study, and the time of year. The more time spent by the investigator thinking through the project and creating a complete application package, the faster the review process will go. Being sure all investigators have completed CITI training will also speed up the process. Please plan ahead and allow several weeks for any submission. If you have a specific deadline your project needs to be approved by, please state that clearly in the application and/or the submission email.

AnchorExempt studies – exempt studies do not have to be sent out to a committee reviewer and are reviewed and approved by IRB staff. You should allow a minimum of 7-10 days for an exempt study review.

AnchorExpedited studies – expedited studies are reviewed first by IRB staff and administrative feedback is generally provided to the applicant within 7 days. If you do not hear back in that time, please follow-up to be sure we received your submission. IRB staff will let you know when your study has gone out for review. You should have reviewer feedback within 2 weeks.  You should allow a minimum of three weeks for an expedited study review.

AnchorFull Committee studies – these studies are reviewed by the full committee which meets monthly (deadlines are on the front page of the IRB website). Please submit your study on or before the deadline to give time for IRB staff to provide you with administrative feedback before the meeting. You should receive administrative feedback within 7 days of submission. After the committee meeting, you should receive additional feedback or approval within 5 days.  You should allow a minimum of 45 days for full committee study review.

September-November and February-April are our busiest times so additional time may be needed due to volume. During the summer months many reviewers are unavailable so review times may be longer.