NOTE: HARP IRB will not be accepting the submission of new protocols from January 18 - February 1, 2019, for a major update
The Dept. of Health and Human Services has revised the Common Rule which governs the protection of human research subjects for all federally funded (and much non-federally funded) research in the United States of America. Because of this change the HARP-IRB system will be updated to meet the new requirements. These alterations are currently underway and we anticipate having them in place and working well by February 1, 2019. The Revised Common Rule itself will be operational as of January 20, 2019. From January 18 to February 1, 209 the HARP IRB system will be closed to the submission of any new protocols involving human subjects research while we make the change over for the system and test it.
Here are some slides that will help explain the changes.
The HSC is LBNL's IRB and meets typically once a month. The committee is made up of staff scientists and community members and considers any research at LBNL involving humans or human tissues. Federal regulations concerning scientific research using human subjects may be found on the Office of Human Research Protection.
Human/Animal Research Protocol Management System (HARP)
The HARC office has an online database for managing human subjects protocols: the Human/Animal Research Protocol management system, or HARP. Researchers submitting new protocols or wanting to renew or amend already approved protocols must use the new system. If you are on an LBNL computer,and logged into anything (email, calendar, etc.) where you have already typed in your LDAP password, the HARP system can be accessed through our webpage using this link. If you are on a non-LBNL computer, you can get access from offsite either by logging on to your LBNL computer remotely, or through the use of Virtual Private Network (VPN) software, available to LBNL employees form the IT Division website. You may call the HARC office at x5399 or send email to firstname.lastname@example.org with any questions. This frequently asked questions document may be of some use to you.
All principle lead investigators and their responsible research staff named in the protocol must have an account on the HARP system. The HARC staff are currently setting up new accounts. Please send us all the information requested in this role and account information document to email@example.com.
There are several basic types of human subjects protocols. They are described below. The HARP system will step you through the definitions and submission processes once you enter it.
Exempt protocols Research involving pre-existing human data or tissues with no identifying information attached will typically be exempt from needing a full protocol. In fact, if tissues are obtained from a federally assured public tissue bank no review of any kind may be needed. If you think your research may qualify as not human use, please call the HARC office at 510/486-5399 to discuss this with Dianna Bolt. An exemption is needed then, if you do not already have a HARP account, please fill out this form and send it as an email attachment to firstname.lastname@example.org. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an exempt protocol.
Non-exempt research If in your research you will be using human tissues or collecting data of any sort from identifable sources, then you must complete the full protocol process (see below). Possible scenarios: 1) you will be receiving encoded samples from collaborators at other institutions such that the identity of the subject tissue donors is unknown to you. If, however, you will be returning tissues, or data to your collaborators at those institutions, and especially if any part of this information will be returned to the subjects, then you must complete a full protocol. 2) Or you may be conducting an energy study of low risk in subjects' homes or at their work, sampling air quality, or testing whether a new appliance works more efficiently. If these or similar scenarios describe your work, then your protocol may be judged by the HARC office and the Human Subjects Committee and its policies to be expeditable, but you will still need to file a non-exempt protocol in HARP. Fill out this form and send it as an email attachment to email@example.com. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an expedited protocol. Please note that you will need to upload into the HARP system a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval. Any questions should be directed to HARC office staff at x5399.
Full If the research you are planning to conduct at LBNL involves interaction with human subjects, then you must submit a detailed protocol outlining the nature of the research, recruitment of subjects, procedures to be used, storage of data, etc. In other words, you need full review of your protocol, your consent form(s), your recruitment flyer or letter, and any other materials relevant to protecting the health, safety, and confidentiality of your human subjects. If you and all of your responsible staff members do not already have an account on the HARP system, please fill out this form for all relevant personnel and send it as an email attachment to firstname.lastname@example.org. Once you have all needed accounts please enter the HARP system and proceed to follow instructions for submitting a full protocol. Please feel free to call the HARC office at x5399 for any help you may need with this.
Note that the UCB campus IRB (CPHS) website has a detailed policy on securing data. Please review this policy: Data Security . You may call the HARC office at 486-5399 if you have any questions about this.
You will need to fill out a consent form for prospective subject to read and sign before they are part of the study. You may need more than one such form. For example, of you have control and experimental subjects, the two study populations will need their own consent forms. If you are studying minors, they may need different consent forms pitched to different age groups. With minors you may also need to create assent forms for parents or guardians of the minors to read and sign. Consent forms cannot be created within the HARP system, but must be created as external documents, then uploaded into HARP. Please call the HARC office at x5399 with any questions.
The LBNL Human Subjects Committee has worked out a checklist for items recommended for consent forms, and this checklist, a standard outline and two specific models are available for LBNL researchers. Use the routine phelebotomy or blood draw consent form for any study involving a blood draw, or for general reference. The biomedical research consent form is for research involving complex medical procedures involving greater than minimal risk, such as PET or MRI scans.
One concern with writing consent forms is that they should be written to be understandable by a potential subject with a 10th grade reading level. This can be quite a challenge if one is dealing with medical or scientific terminology. We have available a glossary of lay terminology which can be useful in "translating" medical terms into more commonly used language.
You should also attach a copy of the California Medical Research Subject's Bill of Rights to your consent form.
- Consent form checklist
- General consent form outline
- Routine phlebotomy/blood draw consent form model
- Biomedical procedures consent form model
- California Medical Research Subject's Bill of Rights
Collaborative and other non-exempt research If your research involves receiving encoded samples from collaborators at other institutions, or at LBNL, such that the identity of the subject tissue donors is unknown to you and you will be returning tissues, or data to your collaborators at those institutions, and especially if any part of this information will be returned to the subjects, then you must submit your protocol through the HARP system to submit it as an Expedited Verfication Assessment or EVA. You must also submit (upload into HARP) a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval.
Note: to avoid delays, if you have any question about whether your study qualifies an an EVA please call HARC office staff at x5399. New researchers and first time LBNL human subject protocols submittees are well advised to consult with HARC office staff before submitting protocols to HARP.
Working with another UC campus: If you will be relying on the review of another University of California's IRB, please use the NOITR (Notice of Intent to Rely) path in the HARP system. Basically the 'paperwork' for the other UC's IRB must be done first and filed there. Once the reviewing IRB has approved the complete application, you will be informed of this via the UCOP Reliance Registry system. Please call the HARC office staff at 510/486-5399 if you have any questions, or send them email at email@example.com.
Can I use cannabis in my research?
> Not quite yet. See this document from the University of California Office of the President on 7/24/2018 on the use of cannabis in federal research. This is an evolving field however, and things can change in the future.
**Please note that the HARC office has moved. If you need to send a paper item through the mail to the HARC office use the mailstop 50A-1148. The office is physically located in 50A-1145.**