News

New Attachment Requirements for Surveys, Questionnaires, and Interview Guides

Effective 4/1/2017: CPHS has re-evaluated its requirements concerning the level of detail needed for instruments used to collect data from research subjects. To reduce investigator burden and speed up review turn-around times, flexibility regarding these requirements will be applied to qualifying projects. See the following guidance document for more information: Attachment Requirements for Surveys, Questionnaires, and Interview Guides.

Updated MRI Guidelines

Effective Immediately (3/1/2017): CPHS’ Magnetic Resonance Imaging (MRI) in Research guidelines have been updated to remove pregnancy testing requirements for women of childbearing potential.

Any investigator with an approved CPHS protocol involving MRI procedures may submit an amendment application to remove pregnancy testing procedures.

New Time-Saving Submission Change for CITI Training Certificates

As a courtesy to the UCB research community, effective immediately (11/10/2016), CPHS will no longer require researchers to include their CITI human subjects training completion reports in the Attachments section for eProtocol submissions. Instead, OPHS staff will check CITI records to look up each person’s name, passing score, and completion date, to verify training of all listed research personnel. In addition, researchers will no longer need to insert CITI completion dates in the Personnel Information section of the application.

New PowerPoint for Training: “Working With Research Study Participants: An Overview”

Many UCB researchers design studies that engage external collaborating staff (e.g., enumerators, non-profit agencies which assist with recruiting, interviewing, and/or running focus groups). Unless the external collaborators are affiliated with an institution with a human subjects research (HSR) training program in place, the UCB PI is responsible for assuring that the external collaborators receive appropriate HSR training prior to their interacting with subjects.

Rather than ask individuals who have limited study responsibilities to fulfill the requirement by taking the CITI course, UCB researchers often prefer to conduct the training themselves and seek OPHS guidance on how to go about this.

To assist the research community, OPHS is happy to announce the creation of a PowerPoint presentation template for this purpose. For further details, consult the FAQ on this topic.

Researchers who are unsure about whether the presentation is appropriate for a particular situation, or who have questions about how to use this resource, should contact [email protected] for guidance.

OPHS welcomes feedback regarding researchers’ experiences with the presentation PowerPoint. We would also appreciate suggestions for future iterations.

New Guidance Documents Available!

Two new Committee for Protection of Human Subjects (CPHS) guidance documents are now available to help facilitate research at UC Berkeley:

Genetic/Genomic Research is a resource for investigators planning to use human specimens (e.g., blood, saliva, etc.) and/or genetic or genomic data as part of their research. The guidelines discuss risks, informed consent issues, confidentiality and retention of specimens and data, sharing data, financial aspects, and disclosing individual research results and incidental findings.
Mandated Reporting for Suspected Child, Elder, or Dependent Adult Abuse or Neglect outlines who is legally required to report suspected child, elder, or dependent adult abuse and provides template informed consent language.

For more information please contact OPHS at (510) 642‑7461 or [email protected]. To view all of our guidelines, see CPHS Guidelines.

Mobile Health Apps Interactive Tool

Researchers - here’s new regulatory guidance on mobile apps that you should know about if you are creating and testing an app in a human subjects research project. See the FTC Mobile Health Apps Interactive Tool for more information!

CPHS/OPHS Spring Schedule

CPHS/OPHS is in the midst of our busiest time of the year. Please be patient with us as we work through the huge volume of protocols currently being submitted to us and note that review timelines may be longer during the Spring semester.

Announcing New UCB Exempt Category 7 for Certain Minimal-Risk Human Research Activities

The Committee for Protection of Human Subjects (CPHS) and the Office for Protection of Human Subjects (OPHS) are pleased to announce a new category for exempt review. This category, which we have added to the six categories of exemption described in federal regulations, is allowed within the flexibility available under UC Berkeley’s Federalwide Assurance (FWA) and was created to reduce researcher burden.

To qualify for exemption under UCB Category 7, a human subjects research project must be non-federally funded or regulated and comprised only of minimal-risk activities that will not induce distress beyond that of daily life and that could not reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way.

These activities may include (but are not limited to) non-physically invasive interventions or performance of tasks such as: reading/writing/drawing tasks; physical activities such as walking, sitting, or manipulating an object; computer tasks and/or Internet searches; talking and/or listening to words, then making selections, or “think-aloud” exercises; viewing media; role-playing; completing a specific physical or mental action (“imagining”); passive monitoring of space (environment) with sensors; playing a game; and height/weight measurements.

To qualify, the research must not involve any exclusions listed in the CPHS Policy Determination of Exemption:

For more detailed information, please see CPHS Determination of Exemption Policy and CPHS Exempt Research Guidelines.

If you have questions about Category 7 exempt research, please call the OPHS Analyst of the Day at (510) 642‑7461 or email us at [email protected].

CITI Program Browser Compatibility

The Collaborative Institutional Training Initiative (CITI), where the UCB Human Research and Responsible Conduct of Research online training coursework is hosted, is adding several usability enhancements and new features. Due to these features, beginning March 2015, CITI Program’s website will block use of Internet Explorer version 7. Site users will need to have IE 8 or later, or use a current version of Chrome, Firefox, or Safari.

MOOCs and Human Subjects Research

Rebecca Armstrong, Director of Research Subject Protection, has published an article on the Public Responsibility in Medicine and Research (PRIM&R) blog, Ampersand. The article, Getting ahead of the wave: MOOC’s and human subjects research, discusses the issues of massive open online courses (MOOCs), educational research, and, by extension, human subjects research and IRB review.

Older News

Updated Confidentiality and Privacy Questions on eProtocol Non-exempt Applications - Effective 8/4/2014

The non-exempt eProtocol applications were revised on 8/4/2014 to reword privacy and confidentiality questions for better clarity and reduce redundancy. Changes are in Section 17 of the IRB -Biomedical Non-Exempt form and Section 13 of the IRB -Soc-Behav-Ed Non-Exempt form. Note that these changes affect all non-exempt forms (both newly created and existing). This section will need to be revised for any amendments and continuing reviews submitted, and also for protocols currently in the process of review. Please direct any questions or concerns to the Office for Protection of Human Subjects at [email protected] or (510) 642‑7461.

Guidance Documents Available for Undergraduate-Initiated Research Activities

The Committee for Protection of Human Subjects (CPHS) and the Office for Protection of Human Subjects (OPHS) have developed two documents to help guide undergraduate-initiated research activities (UIRA).

These documents are on the CPHS/OPHS website under CPHS Guidelines. The first document, Ethical Issues in Student-Initiated Research Activities with Human Participants, walks undergraduate researchers through important ethical considerations that arise in human subjects research: designing the research to minimize risks to participants, creating an environment where participants are informed and are free from coercion, and providing protection for individuals who are members of a vulnerable group.

The second document, Guidance on Designing Student-Initiated Research Activities, is a practical step-by-step document on how undergraduates should select their population, recruit subjects without undue influence, obtain informed consent, minimize risk, and keep data confidential.