HSU Institutional Review Board

IRB Organizational Chart

To submit a study involving human subjects, first the type of review requested must be determined, either Exempted Research, Expedited Review, or Full Review.

• Exempted Research must fall into one of 8 categories as outlined on the Exempt Research Application. Examples may include studies using only surveys, interviews, educational tests, and benign interventions.
• Expedited Review may be conducted for research that is minimal risk and falls in one of 7 categories outlined on the Expedited Review Application. Examples may include collection of sound and video recordings, collection of biological samples from noninvasive procedures.
• Full Review must be conducted for all research that are more than minimal risk and do not fall in either the Exempt or Expedited categories.

The following flowcharts serve as abbreviated guides for the most common applications received by the HSU IRB. If you believe your research falls under an exemption, please ensure to review the ENTIRE Exempt research application to select the correct exemption. Incorrect form submission will delay the processing of your application.

 

 

 

Exempt Research Application

Expedited Review Application

Full Review Application

If you need additional guidance, more detailed flowcharts provided by the Office for Human Research Protections (OHRP) may be found here: http://www.hhs.gov/ohrp/sites/default/files/full-2016-decision-charts.pdf.

Download and complete the appropriate application for your research from the Applications linked below. Complete all supplementary documents that are required for each application. Email all documents as separate files to IRB@zjhsycw.com.

Submit all documents with the last name and first initial of the Principal Investigator before the assigned file name.

• Ex. Smith J HSU Exempt Research Application.docx
• Flower P Full Review Application.docx
• Flower P Investigator and Faculty Advisor Assurance Form.pdf

HIPAA and IRB

Note: All Submissions must be accompanied by the signed Investigator and Faculty Advisor Assurance Form.

For Exempt Applications submit the following

• HSU Exempt Research Application (required)
• Investigator and Faculty Assurance Form (required)
• Informed Consent Form (required)
• Human Subjects Research Training Certificate(s)- see Training below
• Surveys (if applicable)
• Vulnerable Populations Considerations Form (if applicable)
• HIPAA/FERPA form (if applicable)
• Other (e.g., photos, solicitations, etc.) (if applicable)

For Expedited Review Applications submit the following

• HSU Expedited Review Application (required)
• Investigator and Faculty Assurance Form (required)
• Informed Consent Form (required)
• Human Subjects Research Training Certificate(s)- see Training below
• Vulnerable Populations Considerations Form (if applicable)
• Surveys (if applicable)
• HIPAA/FERPA form (if applicable)
• Other (e.g., photos, solicitations, etc.) (if applicable)

For Full Review Applications submit the following

• HSU Full Review Application (required)
• Investigator and Faculty Assurance Form (required)
• Informed Consent Form (required)
• Human Subjects Research Training Certificate(s)- see Training below
• Vulnerable Populations Considerations Form (if applicable)
• Surveys (if applicable)
• HIPAA/FERPA form (if applicable)
• Other (e.g., photos, solicitations, etc.) (if applicable)

Should you have any questions regarding the email submission process, please contact the IRB at IRB@zjhsycw.com  or the chair of the IRB, Megan Smart at 325-670-1818.

Proposals are typically distributed to committee members within a week of their receipt (except during University holidays and breaks). Investigators will receive confirmation their proposal was received when it is sent out for review. Reviews may take 4-6-weeks. Delays are expected around holidays, breaks or vacations (i.e., summer). Please allow time to provide clarifications to the committee.

Proposals are determined by the committee as either:

• • Approved
  • Approved with Modifications
  • Further Information Needed
  • Denied

Approved proposals may be initiated immediately. Proposals requiring modifications should be resubmitted with the required changes within one month. Proposals requiring more information or those that are denied may be reworked and resubmitted to the committee at a later date.

Projects are generally approved for a period of one year. Investigators who are conducting projects that extend beyond this time frame should notify the IRB of the expected date of completion and request extended approval. Likewise, primary investigators are expected to report significant changes in protocol or adverse effects immediately to the IRB.

HSU IRB Internal Review Process

HSU complies with the Department of Health and Human Services regulations 45 CFR 46. Prior to the initiation of any study involving human subjects, investigators must have sufficient training to ensure the protection of human subjects. All HSU investigators must provide certification of a Human Subjects Training course prior to submission of a request. Researchers may choose one of the following options:

1. Complete the following free short courses from the Global Health Training Centre:
   – Introduction to Clinical Research (http://globalhealthtrainingcentre.tghn.org/introduction-clinical-research/) OR The Research Question (http://globalhealthtrainingcentre.tghn.org/research-question/)
   -Introduction to Informed Consent (http://globalhealthtrainingcentre.tghn.org/introduction-informed-consent/)
2. Protecting Human Research Participants online course ($39.99, http://phrptraining.com)
3. CITI IRB Basic- Human Subjects Research ($129.00, http://about.citiprogram.org/en/series/human-subjects-research-hsr/)

Researchers conducting federally-funded studies OR are collaborating with sister institutions are encouraged to complete option 2 or 3 above.

Training must be completed every 4 years.

If you are a HSU Faculty or Staff member who is collaborating with Primary Investigators from another institution and obtain IRB approval from the collaborating institution, please submit the following to IRB@zjhsycw.com.

• IRB approval letter from the home institution
• Proposal Submitted
• Investigator Human Protections Training Certificates
• Signed Investigator and Faculty Advisor Assurance Form
• Any supplementary information provided to the home institution (e.g., consent form, surveys, etc.).

If you are an external researcher wishing to conduct research with HSU faculty, staff or students, please the complete the External Research Review form and email it to IRB@zjhsycw.com.

HSU IRB External Review Process

The IRB Chair will communicate with the investigator as necessary. Upon receiving a proposal, the IRB Chair may request clarification or the submission of missing information. Investigators should respond to the IRB Chair as promptly as possible.

As feedback arrives from the committee members, the Chair compiles comments and communicates with the investigator using detailed, numbered comments. The investigator should respond to each numbered comment, and make appropriate modifications within the proposal, consent forms, or appendices. A letter, restating each comment, where and how comments were addressed should be included in a response to the IRB. Color highlighting (and mention of that in the cover letter) is often helpful in demonstrating where changes have been made.

A consent form is needed for all proposals. All subjects should be provided with a personal copy of the consent forms. It is the responsibility of the investigator to maintain records of the consent forms.

45 CFR 46 requires specific elements to be included in an informed consent and these are outlined in 46.116. Briefly they are as follows:

1. A statement that the study involves research, an explanation of the purpose and expected duration of the subjects’ participation.
2. A description of the procedures and reasonably foreseeable risks or discomforts
3. A description of the benefits to subjects or others
4. A disclosure of appropriate alternative procedures or treatments
5. A statement describing the extent of confidentiality
6. An explanation of whom to contact for answers to questions or subjects’ rights, and whom to contact in the event of a research-related injury
7. A statement that participation is voluntary or participant may withdraw at any time

Some examples are provided:

• Traditional Face-to-Face Research – With more traditional research occurring in a classroom or lab, a paper-pencil consent form is useful where subjects provide an actual signature.

In Person Consent Template

• Computer/Email Surveys –The consent letter should contain the same elements as a traditional consent form, however, the subject provides consent by initiating the survey.

Computer-based Consent Template

• Consent/Assent for Minors –Studies involving minors or those who are unable to provide their own consent must have the consent of a parent or guardian. If able, those subjects should provide assent to participate. Studies involving minors often must undergo an expedited or full review.

Yes. In order to avoid survey fatigue, survey research is limited to the delivery of 1-2 proposals per month. Please check with the IRB chair in this regard. Survey research will be managed in collaboration with the IRB and Institutional Technology. Student email addresses are not shared with investigators. There may be a charge for the conduct of these projects depending on their complexity and availability of IT staff.

For all studies that were approved by expedited for full board review, any and all proposed changes must be approved prior to implementation (except to prevent the immediate harm to participants).

If the study is not being amended in a way that changes its classification, please submit the following to IRB@zjhsycw.com.

• Updated Expedited or Full Review Application with changes highlighted
• Signed Investigator and Faculty Assurance form

If the study is being amended in a way that changes its classification (ex. increasing risk from minor to moderate, or causing it to no longer fall under an exemption), please submit a NEW application to IRB@zjhsycw.com using the corrected form. Additional information will be required to approve the proposal.