Institutional Review Board (IRB)

• New Study Application
• Continuation Application
• Project Status Report
• Amendment Application
• Final Report
• Event Reporting
• Oversight Determination Form
• Request for Clearance – Class Projects

Collaborations and IRB Reciprocity

• Reliance FAQ's

IRB Guides

• CITI Human Subjects Training Instructions
• Image Release FAQ
• Study close-out
• Flyer Template
• Letter of Support Template

Consent Form Templates (Updated June 2020)

• Consent Form Template
• Consent Form - Qualtrics Survey
• Consent Form - Paper Survey
• Consent Form - Other Online Survey
• Sample Assent Form

HIPAA Information

Below is a link where you can find documents related to HIPAA Research. Please note that this website is only accessible to current WSU faculty/staff/students, which means that non-WSU related individuals will not be able to access.

WSU Privacy Website Information - Home

 

For technical help with these forms please contact Shocker Technical Assistance Center at
(316) 978-4357 or helpdesk@wichita.edu.

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

HIPAA Guidance Materials
http://privacyruleandresearch.nih.gov/pdf/HIPAA_Privacy_Rule_Booklet.pdf

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.

Who 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.

What is the Oversight Determination Form?

If you believe your study is Not Human Subject's Research or may qualify for Program Evaluation or Quality Improvement, then fill out the Oversight Determination form rather than the New Study application.

What 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.

When 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.

Exempt review means exempt from full IRB review, for the following categories (see the Exempt Categories chart under IRB guides for more information):

• Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction, involving normal educational practices. This includes most research on regular and special education instructional strategies and research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
• Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording). This category does not include interventions, only interactions. Please Note: the only research activities involving children that may fall under this exemption are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed.
• Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. Please Note: research activities involving children do not qualify under this exemption.
• Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens. This category allows for both retrospective and prospective secondary uses.
• Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs. Note: these must be posted on a Federal Web site.
• Taste and food quality evaluation and consumer acceptance studies.

What 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.

How 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.

Exempt 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.

Expedited 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.

Full 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.

Exempt 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.

Expedited 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.

Full 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.

Are participants required to provide their SSN in order to be compensated for a study?

Due to IRS regulations, a SSN is usually required in order to receive payment as a research participant. In limited situations, a waiver of this requirement may be requested but this is rare. Please contact Kristie Courtney at 316-978-5988 to discuss your concerns and see if a waiver may be applicable in your situation. Also see the SSN waiver document found under the IRB Applications & Guides tab.

What is a HIPAA for Research Form and why is it required?

The HIPAA for Research form only applies when someone is doing research in a HIPAA covered clinic and they want to access medical records as part of their research.

WSU is what is called a hybrid HIPAA entity – the entire campus is not HIPAA covered, but only certain areas such as AEGD (Dentistry Clinic), SLHC (Hearing clinic), CAPS (Counseling services) and SHS (Student health). Because we are hybrid, HIPAA doesn’t apply to everyone.

All HIPAA covered entities that submit IRB protocol’s will be forwarded to the HIPAA privacy officer here at WSU for review prior to approval so that they can note any concerns and get with those PI’s/clinics if needed.