EH&S
Health Services
Human and Animal Regulatory Committees:
- Human subjects protocols at LBNL
- Renewal of human subjects protocols at LBNL
- Modification or Amendment of a human subjects protocol
- Ending a study with human subjects
- Adverse event reporting
- Conflict of Interest
- Human Terrain Mapping Information
- Certifying a grant proposal for human subjects approval
- Schedule of 2011-2012 HSC meetings and deadlines
- Training in the responsible use of human subjects
- FDA approval of experimental drugs or devices
- HSC Reviewer Documents
- Links to other Human subjects research sites
Human Subjects Protocols at LBNL
Federal regulations require that research involving human subjects or human derived data or tissues be reviewed by an Institutional Review Board. At Lawrence Berkeley National Laboratory the IRB is the Human Subjects Committee (HSC). Here is a copy of our charter and our federal wide assurance with the U.S. Department of Health and Human Services. The HSC meets monthly to consider human subjects protocols, consent forms, recruitment flyers, etc. Researchers seeking approval of research involving humans and/or human derived materials should begin the process well in advance of when such approval is needed for grant initiation or conducting research. It will be necessary to submit multiple forms for each type of protocol listed below.
HARP
The HARC office has implemented a new 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 opening a web page a typing in the url goapp/harp. Or you may use this frequently asked questions document, which will no doubt be added to during the year, but meanwhile 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 harc@lbl.gov.
Please note that to renew or amend an older protocol, you must first enter all the information in that old protocol as a new submission to the HARP system, including uploading as attached documents all consent forms, recruitment flyers, etc. In most cases the HARC staff will be able to accept this old version of the protocol for initiation within one or two days. Researchers should then proceed to use the HARP system to submit their renewal and/or amendment. That renewal or amendment submission will be treated as deemed necessary by the HARC staff, either treated as expeditable or taken to the full Human Subjects Committee for consideration at its next regularly scheduled meeting. Although this may seem like a major inconvenience, even a very complicated protocol can be fed into the HARP system and submitted for intitial acceptance in under an hour.The HARC staff believes that LBNL researchers will find the renewal process quick and easy.
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 Chris Byrne or 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 harc@lbl.gov. 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 data from identifable sources, then you must complete the full protocol process (see below). Note that you may 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. If this scenario describes your research, please fill out this form and send it as an email attachment to harc@lbl.gov. 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 sytem 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 harc@lbl.gov. 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 at http://cphs.berkeley.edu/content/datasecurity.htm . 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, that campus should send a copy of the signed NOITR you, which you will upload it with your submission in the HARP system. Please call HARC officer staff at 510/486-5399 if you have any questions, or send them email at harc@lbl.gov.
Renewals
All human subject protocols must be renewed annually, but the process of renewal differs greatly depending on the type of protocol. The HARC office staff sends out renewal notices approximately six weeks before a protocol is due to expire. For expedited and full protocols, please follow the renewal process in the HARP system. The relevant button for starting the process will be on the left hand list on your protocol screen, towards the bottom. Please call the HARC office at x5399 or send email to harc@lbl.gov with any questions.
Once the full protocol materials have been received, the protocol is considered for renewal at the next meeting of the Human Subjects Committee. If revisions are needed, revision letters are sent out to investigators promptly. Once revisions have been received in the HARC office and approved by the chair of the Human Subjects Committee, the principal investigator is sent a letter of approval. Note: we are no longer stamping consent forms with the latest date of approval. Investigators should use the latest version of the consent form as submitted to and approved by the HSC. Upon request, the HSC can send a certificate to the relevant granting agency or to the Sponsored Project Office.
Modifications
If you wish to modify or amend your protocol, please submit the amendment through the HARP system. The relevant button for starting the process will be on the left hand list on your protocol screen, towards the bottom. Simple changes can be approved on an expedited basis, more complex changes will need to be considered by the full board of the Human Subjects Committee. Please submit your request for modification in a timely manner, taking into account the schedule (given below) of the HSC meetings. Please note that while most changes will be implemented through the "New Amendment" button in HARP, there is a simpler process for changing (adding or deleting) non-responsible staff on the protocol. The button for this ("Create Staff-Only Amendment") is below that for "New Amendment."
Discontinuations
Closure of a study: if your study has been completed, or you wish to withdraw your human subjects protocol for some other reason (loss of funding, principal investigator moving to another institution, etc.) please enter the HARP site and follow the study closure process.
Adverse event
If an adverse event occurs in the course of conducting research involving human subjects, if at all possible within 48 hours of the event, please enter the HARP site and follow the process for a new reportable event. This "New Reportable Event" button is on the left hand list for the protocol, towards the bottom. A phone call to the HARC office, x5399, would also be helpful. If you cannot take these actions within the 48 hour window, please call the HARC office, x5399, at your earliest possibility to discuss. You will still need to enter the HARP system and to through the New Reportable Event process. The HARC office will inform the relevant funding agency as deemed necessary.
COI
Please see the LBNL Regulations and Procedures Manual site for information on conflict of interest matters in regards to human subjects research.
Human Terrain Mapping
If in the course of your research, questions about whether or not the data you are collecting could be used for human terrain mapping, please see the following documents for guidance:If you will be receiving data that has been sufficiently de-identified, please use the following >HTM data assessment tool, which include a data security agreement template.
Certifications
When certification of IRB review is requested: once your human subjects protocol has been approved by the Human Subjects Committee (LBNL's IRB), researchers or their proposal specialists should fill in the certification request form and submit it along with a copy of the grant proposal to the HARC office (MS 26-143; electronic copies ok). The HARC office will perform a side by side review with the protocol and the grant proposal and if it appears that all human use as described in the grant proposal is covered by the human use protocol, then the HARC office will issue a certificate. This certificate is sent to the principal investigator, investigator lead(s) on the protocol, the sponsored project office, and anyone else indicated on the certification request form. The sponsored project office will then send the document to the funding agency as required. The glossary and matrix document contains definitions for terms used in the form, other information, and a matrix which (we hope) deals with every possible permutation of protocol and proposal need for certification. It may be the case that a given grant proposal describes work covered by more than one human use protocol. The regular certification request form contains spaces to list 3 protocols. In rare cases where more than 3 need to be listed, here is a second page of the form to list further protocols. Note that this is a new form and we welcome feedback on ease of use, understandability, etc.Here is the flow chart which gives a over all view of the process. And if you need still further documentation and explanation, here is a guidance document.
Note, if you need the AHU form (also known as the Human Subjects and/or Vertebrate Animal Use in Field Task/Work Proposals form) for a field task or work proposal, you can download the most recent version here. If you need the similar LDRD form you can download the most recent version here
Federal Wide Authorization or FWA
LBNL's Federal Wide Assurance (FWA) number from the US Dept. of Health and Human Services is 00006253.
The document itself may be downloaded here .
Our Office of Human Research Protections (OHRP) IRB number is 00006447.
Studies that are done at other sites, such as UCB or UCSF may be covered by a memorandum of understanding between the
UC system campuses, and in most cases only the host institution's Institutional Review Board will review a
human subjects protocol and deal with grant certification issues. If you have any questions about this,
please call the HARC office at x5399, or send email to harc@lbl.gov.
Note, if you need the AHU form (also known as the Human Subjects and/or Vertebrate Animal Use in Field Task/Work Proposals form)
for a field task or work proposal, you can download the 2008-2009 version here.
If you need the similar LDRD form you can download the
2009-2011 version here
Schedule of 2011-2012 LBNL Human Subjects Committee meetings and deadlines Please note that meetings of the Human Subjects Committee sometimes change and are shifted to earlier or later dates. Please call the HARC office at 486-5399 to check on the deadline for the next HSC meeting.
| HSC deadline | HSC meeting |
|---|---|
| August 15 | August 26, 2011 |
| September 12 | September 23 |
| October 17 | October 28 |
| November 7 | November 18 |
| December56 | December 16 |
| January 17 | January 27, 2012 |
| February 13 | February 24 |
| March 12 | March 23 |
| April 16 | April 27 |
| May 14 | May 25 |
| June 11 | June 22 |
| July 16 | July 27 |
Training
In June 2000 the National Institutes of Health Office of Extramural Research issued a requirement that all researchers conducting research involving human subjects with NIH funds must receive training on the protection of human subjects. Currently the Lab has a short on-line tutorial covering the main points which those researchers using human cell lines should take.
The short LBNL computer based training program on the protection of human subjects can be found at the Lab's training site. Select the EHS 740 course,. The 20 question tutorial takes approximately 40 minutes to complete. Please direct any comments or questions about the tutorial to Dianna Bolt, dgbolt@lbl.gov. Note that the EHS 740 course was updated on March 1, 2011 and all investigators and responsible protocol staff at LBNL who are involved in research with human subjects who took this course earlier must retake it. We are currently asking everyone to take it by the end of July, 2012. If a grant agency requires certification from you for human subjects protection training, after you have completed EH&S 740 contact the training office here at LBNL.
LBNL researchers may also take the CITI online human subjects protection training course. This is a course hosted by the University of Miami Collaborative IRB (Inst. Review Board) Training Initiatives on the ethical use of humans as research subjects. It has multiple modules, such as those on the history of human research subject use, consent form requirements, using vulnerable populations, etc.
In addition to the online tutorials, LBNL offers occasional seminars on ethical subjects of interest to researchers. The next seminar has not yet been scheduled. It will be posted here as soon as the details are known. The last offering was:
Wednesday, November 17st, 2004, bioethicist Gaymon Bennett spoke on the ethics of human stem cell research.
FDA approval
If you plan on conducting human subjects research at LBNL involving an experimental drug or device, additional requirements will apply.
Radioactive drugs utilized for research purposes may fall under the purview of the Berkeley Lab Radioactive Drug Research Committee. The RDRC operates under the authority of the federal Food and Drug Administration (FDA); their governing regulations can be found at : their site . .
Contact Dr. Henry Stauffer, Chair of the RDRC (x7601), or the HARC office staff (x5399) for assistance in determining whether the protocol requires RDRC review.
Researchers using radioactive drugs must file four quarterly and one annual reports on studies conducted using the new drug. See the RDRC website to download the necessary forms and to see the 2011 due dates for these reports.
New drugs being tested to establish efficacy, toxicity or dose must be covered under an Investigational New Drug exemption (IND), from the US Food and Drug Administration. Go to the FDA Investigational New Drug website directly with questions, or contact the HARC Program Analyst (x5399) here at the Lab for assistance. Drugs available for Lab use only under existing INDs held by other investigators will also require special review.
If you plan to use an experimental device, including diagnostic devices, an Investigational Device Exemption (IDE) is required. You may go to the FDA Investigational Device Exemption website directly with questions; or contact the HARC office staff(x5399) here at the Lab to assist you.
HSC Reviewer Checklists
Members of the Human Subjects Committee can use the documents listed below in their reviews of submitted protocols and consent forms for the HSC meetings. Principal Investigators may also like to see these forms, to see what HSC members are looking for in protocols and consent forms.
Links to many Human subjects research sites
University of California at Berkeley Committee for the Protection of Human Subjects homepage: http://cphs.berkeley.edu:7006/
Department of Energy Protecting Human Subjects home page:
http://humansubjects.energy.gov/
Dept. of Energy Human Subjects Program Resource Book: http://humansubjects.energy.gov/doe-resources/humsubj-resourcebook.htm
Dept. of Energy policy on the protection of human subjects, policy and order(DOE 443.1A): http://www.directives.doe.gov/pdfs/doe/doetext/neword/443/p4431a.html
Dept. of Energy former worker medical screening website: http://www.hss.energy.gov/healthsafety/fwsp/formerworkermed/
National Institutes of Health Office of Human Subjects Research home page: http://ohsr.od.nih.gov/
Code of Federal Regulations, CFR 45.46, Protection of Human Subjects: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
Public Responsibility in Medicine and Research homepage: http://www.primr.org/
The Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
World Medical Association, Declaration of Helsinki: http://www.wma.net/e/policy/b3.htm
