Committee on Human Research Processes Clinical Translational Research Fellowship Program Curriculum...

Committee on Human Research Processes

Clinical Translational Research Fellowship Program Curriculum Core

Objective

• Clarify Committee on Human Research (CHR) processes for your study.– Is it research?– Is it human subjects? – Type of review?– Resources

CHR Processes

• UCSF Human Research Protection Training and Education Resources– http://www.research.ucsf.edu/chr/Train/chrTrain.as

p#Basic

Prior to moving forward with your study

• Determine – whether your study is a research study– whether your study involves a human subject– Type of CHR review

What is research?

• Research is the “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”– http://www.research.ucsf.edu/chr/about/chrfaq.asp

Is my quality improvement project research?

• If you are collecting data to disseminate/apply to other populations, then generally CHR approval is required.

• If you are conducting a quality improvement project, CHR approval is not required.

• See website/decision algorithm for greater detail: – http://www.research.ucsf.edu/chr/Apply/RefGuide.asp

– http://www.research.ucsf.edu/chr/Guide/HSDecisTree.pdf

Definition of Human Subjects

• A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the

individual, or

(2) identifiable private information [45 CFR 46.102(f)]

• If your study is a research study involving a human subject, your study requires a CHR approval.

Do students need to submit their proposal for CHR review and approval?

• The Committee on Human Research (CHR) must review all research that involve human subjects performed by UCSF faculty, staff, or students.– http://www.research.ucsf.edu/chr/about/

chrfaq.asp

Types of CHR Review

• Full committee, expedited, and exempt are three types of CHR review; the type of review is based on the level of risk in your study

• Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research. Minimal risks are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Types of CHR Review

• Studies with greater than minimal risk

→ Full CHR reviewExamples: randomized studies, studies using an

investigational drug

• Studies with no greater than minimal risk

→ Expedited or exempt CHR review

• For more details, see– http://www.research.ucsf.edu/chr/Guide/

AppCommRevGI.asp#Type

Do you need to do the on-line Collaborative Institutional Training Initiative (CITI) Training?

• Yes, if you are “key personnel.”

• Key personnel are defined as: • “…all individuals who contribute in a substantive way to the scientific

development or execution of the study at or on behalf of UCSF or affiliated institutions. Typically, these individuals have doctoral or other professional degrees, although other individuals should be included if their involvement meets the definition of Key Personnel. In particular, investigators and staff involved in obtaining informed consent are considered Key Personnel.” http://www.research.ucsf.edu/chr/Train/CITI_FAQ.asp#key

Prior to moving forward with your study

• If your research proposal is linked to an existing research study, ask your mentor to see their CHR documents. – Carefully review the sections on risks, benefits and

vulnerable groups – Review the consent forms.

• Will your study pose any new risks? Will new tools be administered to subjects?

Prior to moving forward with your study

Can a minor modification to an existing protocol be submitted?

or,

Do you need to submit a new application?

Where to go for help

• UCSF Human Research Protection Program– http://www.research.ucsf.edu/chr/

• Your mentor

• CTSI Ethics Consultation– http://ctsi.ucsf.edu/consult

Summary

• Research involving a human subject requires CHR approval

• Many resources are available at UCSF for the ethical conduct of research

CTRFP* Curriculum Core

• Rebecca Jackson MD, School of Medicine

• Barbara J. Burgel, RN, PhD, School of Nursing

• George Sawaya MD, School of Medicine

• Susan Hyde DDS, MPH, PhD, School of Dentistry

• Jaekyu Shin, PharmD, School of Pharmacy

• Joel Palefsky MD, School of Medicine

* Clinical Translational Research Fellowship Program