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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. 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 the following three forms must be submitted to the HARC office to begin the process of applying for exempt approval:
Non-exempt research If in your research you will be using human tissues 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 create a human subjects protocol, using this sample short form protocol as a model, and submit it to the HARC office, 26RO143. You must also submit the CoverSheet, the conflict of interest forms (see below), and a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval. The HARC office needs one copy of the protocol, the original of it, and one copy of all other materials. Any questions should be directed to Chris Byrne at x5507. 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. The Lawrence Berkeley National Laboratory Human Subjects Committee has created a protocol narrative form that covers all the basic areas that must be addressed. Please use this form to write your protocol, deleting those sections that are not needed, and expanding other sections where more explanation is called for. 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 . Please call the HARC office at 486-5507 if you have any questions about this.Note that you will also need an HSC application cover sheet. If you check "yes" on question 10 on the coversheet, you may need to fill out the HIPAA authorization form. Please call Chris Byrne at 486-5507 with any questions about this. Conflict of Interest forms: LBNL researchers are required to submit the LBNL conflict of interest forms (see below, #s 7 and 8) with their protocols. Any questions about filling out the forms can be answered by checking the online Regulations and Procedures Manual page: http://www.lbl.gov/Workplace/RPM/R10.09.html . Call Chris Byrne at x5507 with any additional questions. Consent forms: 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.
To sum, for protocols involving interaction with human subjects and needing full committee review,
researchers should submit nine copies (with the exception of the COI forms, for which we only
need one) and the original of the following :
or
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 complete a full protocol, but you may use the short protocol form, and skip the consent forms and recruitment materials. You must also submit the LBNL coversheet, the conflict of interest forms (see above), and a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval. The HARC office needs one copy of the protocol, the original of it, and one copy of all other materials. Note: to avoid delays, if you have any question about whether it is appropriate to use the short form, as opposed to the long form, please call Chris Byrne at x5007. New researchers and first time LBNL human subject protocols submittees are well advised to consult with Chris before filling out forms. Three special cases: 1) If you will be relying on the review of another University of California's IRB, please download the Notice of Intent to Rely form (NOITR) and follow the instructions on the form carefully. 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 to the relying IRB. Please call Chris Byrne at 510/486-5399 if you have any questions, or send her email at harc@lbl.gov. 2) If you have a core or training grant that will support future studies of human tissues or data, to be determined at a later date, then please submit this form, along with the LBNL cover sheet and conflict of interest forms as needed (items 3, 4, and 5 in the list below). 3) If you want to have a new grant or funding proposal certified on the basis of an existing LBNL protocol, you must file a an amendment to your existing protocol. The protocol must be in good standing with the Committee (i.e., not expired or late for renewal). Please submit a letter such as the sample, in addition to:
or You need only submit a copy of an amended protocol and other supporting materials (such as amended consent forms) if the addition of the grant will mean a change in the scope of the study, experiments to be done, subjects to be recruited, etc. In such a case, one copy of the amended protocol, using the protocol narrative form , and attachments. If you have any question about this, please call Chris Byrne at 510/486=5507.
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 two months before a protocol is due to expire. If the protocol is
exempt, the principal investigator simply checks, signs, dates, and returns the letter to the HARC office (MS 26R0143) within a month. If the protocol is eligible for expedited review (as stated on the approval letter), just the original and one copy of all materials listed below need to be submitted to the HARC office, MS26RO143. However, if the protocol needs full board review, send the original and nine copies of latest version of the protocol*, along with the latest version of the consent form(s), any recruitment materials, etc., must be submitted to the HARC office (MS 26RO143) by the due date given in the email reminder. If you previously used the short protocol narrative form and it was approved, then you may do so again. In sum:
1. The latest version of the protocol*, using the protocol narrative form
** Online forms with very small font are more readable if the viewer increases the zoom box from 100% to 125% or 150%. 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.
If you wish to modify or amend your protocol, please submit the amendment application form, along with whatever documents have been modified, such as the protocol (using the protocol narrative form ), consent form(s), or any other relevant materials. A new application cover sheet may need to be submitted, depending on the nature of the modification that is being requested. 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.
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 submit the Closure of Study form .
If an adverse event occurs in the course of conducting research involving human subjects, please fill in the adverse event form and send it within 48 hours, if at all possible, to the HARC office, MS 26RO143, electronic copy ok if followed by original. The HARC office will inform the relevant funding agency as deemed necessary.
When certification of IRB review is needed for a funding agency: 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.
Federal Wide Authorization or FWA
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.
Schedule of 2009-2010 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.
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. While the Lab does have a short on-line tutorial covering the main points which those researchers using human cell lines should take, a more extensive on-line tutorial is currently in development. Updates will be posted to this site when available. The short Berkeley Lab’s computer based training program on the protection of human subjects can be found at: http://ehswprod.lbl.gov/EHSTraining/hsrt/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. If a grant agency requires certification from you for human subjects protection training, after you have completed the tutorial ontact their SPO Contracts Officer. If you are not sure who this is, your lab supervisor should know. A list of Contract Officers and their associated divisions can be found on the Sponsored Projects Office website The SPO will provide certification directly to the agency for you. 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.
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 Program Analyst Chris Byrne (x5507) 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 2008 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 (x5507) 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 Program Analyst Chris Byrne (x5507) here at the Lab to assist you.
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.htmDept. 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.htmPublic Responsibility in Medicine and Research homepage: http://www.primr.org/The Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmWorld Medical Association, Declaration of Helsinki: http://www.wma.net/e/policy/b3.htm |
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