Instructional Guidance and Sources for Human Subject Investigators

CB043867

The following documents and information sources are to assist investigators as they are designing or modifying their protocols.

For further assistance or information, you may contact the Office of Research Compliance at 817-735-0409

What is Human Subject Research?

This booklet provides an overview of human subject research and what is not human subject research. To access and read this booklet, your computer must have adobe acrobat. For further assistance in identifying if your study is truly human subject research (in which case you would need IRB review) please call the ORC.

Designing Research Protocols

Focus Group Guidelines This packet provides guidance to investigators designing focus group research studies. This includes the information required for proper IRB review and guidance on consent for focus group studies as well as sample consent forms. You must have MS word capabilities to access this document. We would like to extend our grateful appreciation to Dr. Coggin and Dr. Lurie, principal investigators and professors at UNTHSC for permission to use their informed consent and other research-related documents for educational purposes.

Re-contacting Subjects from Existing Research Studies This document provides guidance and recommended procedures from ORC and the IRB in regard to “re-contacting” research subjects either for future studies or to obtain additional information. This includes information on how to design a protocol to incorporate such element as well as information required for proper IRB review. You must have adobe acrobat capabilities to access this document (pdf).

Guidance on International Research Federal regulations require that all international research with human subjects must have the appropriate safeguards in place to protect the rights and welfare of the subjects. This manual will provide investigators considering or designing international research guidance on the federal requirements for conducting such research. This is a pdf file and you must have adobe acrobat to access it.

Research using Human Biological Materials (Samples) This document offers guidance on research using human biological materials. This piece specifically defines what is considered to be human biological research, evaluates the different levels of risk associated with this research, and how to conduct ethically sound research with human biologics. Using this special “Protocol Synopsis for Research Involving Human Biological Materials (Biospecimens) and Related Behavioral/ Health Data” form, the investigator will be directed on how to provide sufficient information for an appropriate and timely IRB review. For more assistance or guidance on this topic, please contact the ORC.

NOTE: Projects involving the collection and use of any human biological material (e.g., urine, blood, tissue samples, etc.) must also obtain approval from the Institutional Biosafety Committee (IBC). The Biosafety Office is NOT part of the IRB and the approval process is separate from that of the IRB. However, for IRB approval, you will need IBC approval if you are working with human biological material. Please contact the Biosafety Program Office (ibc@unthsc.edu) for more information and submission requirements.

Research involving Chart Reviews This document offers directed guidance on research using review and analytical research of medical records, medical charts (“chart reviews”) as well as case studies on individual patients. Using this special “Protocol Application for Research Involving Chart Reviews” form, the investigator will be directed on how to provide sufficient information for an appropriate and timely IRB review. For more assistance or guidance on the topic of chart reviews and case studies, please contact the ORC.
Research involving materials (data, records) that have been already collected This document/form directs investigators to the key points, issues and information needed to conduct a timely and effective IRB review of research involving materials (data, records, documents) that have been previously collected. The MS Word document serves as a protocol synopsis template. For more assistance or guidance on this topic, please contact the ORC.

IRB Protocol Synopsis for Research Projects Involving Human Subjects

How to prepare a Protocol Synopsis for IRB Review This document provides guidance to investigators on the information required for the IRB to conduct a proper review of a research protocol. As this is a pdf file, your computer must have adobe acrobat to access it. Please DO NOT INCLUDE THESE INSTRUCTIONS with your submitted IRB packet.Here is a “fillable” version (MS Word) of this document to use when drafting your own protocol synopsis for IRB submission.

Designing Research-Supporting Documents

Guidance for Designing Advertisements This document provides guidance on how to design recruitment material in compliance with federal regulations. Remember the IRB must review and approve all recruitment materials (e.g. flyer, radio or tv ads, etc.) as it is considered part of the informed consent process. Please contact UNTHSC Marketing for appropriate locations to post IRB-approved recruitment material. You must have MS word capabilities to access this document.

Telephone (Recruitment) Script This document is a sample/ template of a telephone recruitment script. Note that as recruitment is part of the consenting process federal regulations require IRB review and approval of the information presented to subjects (when they are called). Also consider that certain consent elements such as study procedures, contact information, who is conducting research, etc. needs to be included in such script. For further guidance regarding the need for a phone script, please contact the ORC staff. To view this document, you must have MS Word capabilities.back to top

Consenting Research Subjects

Study Consent Cover Letter Template This document is a template of a consent cover letter. A consent cover letter has the elements of a full-fledge consent document. However, it does not have a section for documenting the consent process (i.e. no subject signature). You must obtain a Waiver of Documentation of Informed Consent to use this type of consent document/method. Please contact the ORC staff to see if your study qualifies for such waiver. To view this document, you must have MS Word capabilities.

Research Statement Online Survey This document is a template of a research statement used to inform subjects about the study prior to engaging in an on-line survey. The on-line statement can be brief and is offered in-lieu of a full-fledge consent document but it still contains the same basic elements of consent. With an on-line survey and use of an on-line research statement, you will need to request a Waiver of Documentation of Informed Consent (waiving the requirement to obtain a signature). Please contact the ORC staff for additional guidance about this waiver. To view this document, you must have MS Word capabilities.

Guidelines for Re-consenting Subjects This document provides information to investigators regarding re-consenting subjects. In particularly, this guidance piece describes when such step is necessary/ required. As this is a pdf file, your computer must have adobe acrobat to access this document.

When Minors Become Adults (during a research study) This document offers guidance to investigators including consent language regarding the need to re-consent research participating minors once they become adults. Recall that the regulations require that a former child “re-consent” to be in research but now as an adult. You need adobe acrobat to access and download this file.

Consenting Non-English Speaking Subjects

Guidelines for the Use of the Short (Consent) Form: This document provides guidance to investigators on how to consent non-English speaking subjects using a Short (Consent) Form. A Short Form is a more “condensed” version of the Informed Consent document and should be used for the occasional and unanticipated recruitment of non-English speaking subjects.

How to Fill Out the (IRB) Forms

How to fill out the Exempt Application For EXEMPT category research, here is an EXEMPT Application with some descriptive language, hints, tips, and notes. This pdf document is for guidance only.  Do NOT print out and use this particular page as your submitted form.

Guidelines to Expedited Category Review Application Here is a question and answer document that can help you fill out the Expedited Category Review Application. If you have any questions regarding Expedited Review, please contact ORC for further guidance. DO NOT submit this MS Word document with your IRB packet.

How to fill out a Full Board Application Here is a Full Board Application with some description language, tips and notes. This document is only for guidance. DO NOT print out and use this pdf document as your submitted form.

IRB Reportable Events

SAE Guidance This information provides investigators with guidance on how and when to report an on-site SAE for a particular study. You must have pdf capabilities to access this document or you may visit the link “SAE Guidance” for more information.

Reporting Protocol Violations The guidance provided in this document covers the definition of a “protocol violation”, examples, reporting methods and how to avoid such events from occurring. Recall that all protocol violations must be reported within 10 working days of discovery of the event.

Defining Protocol Violations This manual is a lexicon created by Norman Goldfab, Chairman of the PDV Code Governing Committee for understanding and communicating protocol deviations and violations. This document also provides some examples of protocol violations and deviations within human subject research.  Please contact ORC for any additional guidance on how to report protocol violations.

Data Storage and Security

Data Storage and Security This document provides investigators with UNTHSC recommended language for data storage and security. This verbiage can be incorporated into the protocol synopsis. You must have adobe acrobat capabilities to access this document.

CITI Training

CITI Training Log-in Instructions For first time CITI users, this provides a step-by-step process of how to log in and register for the CITI Human Subjects Research Training Curriculum.

For further assistance contact CITI helpdesk by visiting their “Contact Us” web page. UNTHSC-IRB does not maintain the CITI website. Note: Your computer must have Adobe Acrobat to read this document.

HIPAA Regulations

HIPAA Compliance Information This provides guidance regarding the Privacy Rule and HIPAA regulations and its application to the realm of human subject research. For additional guidance, please visit “Informed Consent Guidelines” found as a link on our website.

HIPAA FAQs This is a direct link to the Department of Health and Human Services. The information provided in this FAQs section gives general guidance on the privacy provisions of the Health Insurance Portability and Accountability Act of 1986 (HIPPA).

Clinical Trials

Registering a Clinical Trial (ClinicalTrials.gov) Recall that public law 110-85 states that all “applicable trials” be registered on the NIH’s website, “Clinical Trials.gov.” This document provides an explanation and guidance on which clinical trials require registering as well as outlines the sponsor’s and principal investigator’s responsibilities regarding such requirement. To view this piece, you must have MS Word capabilities.

SAE Guidance This information provides investigators with guidance on how and when to report an on-site SAE for a particular study. You must have pdf capabilities to access this document or you may visit the link “SAE Guidance” for more information.

Reporting Protocol Violations The guidance provided in this document covers the definition of a “protocol violation”, examples, reporting methods and how to avoid such events from occurring. Recall that all protocol violations must be reported within 10 working days of discovery of the event.

Defining Protocol Violations This manual is a lexicon created by Norman Goldfab, Chairman of the PDV Code Governing Committee for understanding and communicating protocol deviations and violations. This document also provides some examples of protocol violations and deviations within human subject research.  Please contact ORC for any additional guidance on how to report protocol violations.

Guidance on Regulation of Human Subject Research

The following power point presentations were created by Dr. Brian Gladue, ORC Executive Director, as part of the course “Regulation of Human Subject Research” (BMSC Course 5400). These power point presentations may provide investigators with educational guidance on various human subject research and IRB concepts.

  • Basic Ethical concepts of Human Subject Research
  • Historical Basis of Federal Regulations and Overview of IRB Operation
  • Categories of Review of Human Subject Research
  • Responsibilities of Principal Investigators and Institutional Review Board Members
  • Assessing Risks in Human Subject Research
  • Informed Consent and the Consenting Process
  • Social Behavioral Research (Survey, Interview or Focus Group Research)
  • HIPAA Regulations and Application to Human Subject Research
  • Therapeutic Misconception…From Physician-Patient to Investigator-Subject Relationship

 

 

This page was last modified on August 10, 2016