FREQUENTLY ASKED QUESTIONS

ACRONYMS  
HARC is the Human and Animal Research Committees office, the office that supports the human subjects protection and animal welfare programs.
HARP  is the Human/Animal Research Protocol Management System, the on-line database and protocol entry system at LBNL.
HSC is the Human Subjects Committee, the IRB for Berkeley Lab
IRB  is the acronym for Institutional Review Board, the generic name for an internal board that reviews human subjects research.

GENERAL INFORMATION

What is the Berkeley Lab Assurance of Compliance (FWA) number? FWA 00006253 
What is the definition of a human subject?  A living individual about whom an investigator conducting research obtains (45CFR46.102(d)): 
1. Data through intervention or interaction with the individual, or
2. Identifiable private information.

How do I find out if my research involves human subjects?  Please call the HARC Office at 5399 for an initial determination.  If questions remain, contact HSC Chair Peter Lichty (x6267) to arrange a consultation.
Where do I find the on-line training program that I must take before being listed on a protocol or working with human subjects?  The human subjects training takes about 40 minutes to complete.  It can be found on the Lab’s training site, or by following this link.   EHS0740 Human Subjects Research Training Program.
My colleague, collaborator or staff member needs to take EHS 740 or other acceptable training, but they don’t have LBNL employee or affiliate status.  They can go to the EHS0740 Human Subjects Research Training Program, log on using their e-mail, and then use the completion e-mail they will receive as proof of training.

Do I need to renew my human subjects research protocol if I am no longer using it?  Unless the HSC found the protocol to be exempt, it cannot simply be allowed to expire; it must be either renewed or formally closed.  If you are no longer enrolling subjects and have completed collection and analysis of the data a final report should be submitted for the study through the HARP system.  This very brief final report allows HARC staff to complete mandatory annual reporting and archives the protocol should you need it for reference in the future. 

HARP SYSTEM HOW-TOs
What do I need to do to get started in the HARP system? 
(1)	Apply to have a HARC account and Profile set up for you by completing the first page of  this role and account information document and e-mailing it to harc@lbl.gov.
(2)	Take basic human subjects training (EH&S 740).   EHS0740 Human Subjects Research Training Program
(3)	(Optional) call the HARC office (x5399) and schedule a personal training session. 

How do I get a HARP account?  Download this role and account information document (also found on the HSC website), complete the Account Request form found on the first page, and e-mail it to harc@lbl.gov

To log on to the HARP system:  type goapp/harp in your browser bar, or use this HARP link.  This will take you to the home page for the application.  If you are not already logged in with your l-dap, the application will ask you to do so.  Once you are logged in then you will be taken to your Home Page.

Why do I get an error message when I try to log onto HARP?  You may be trying to log in from a computer that is not recognized as part of the LBNL network.  The HARP system is behind the Lab’s firewall, and can only be accessed by computers recognized as part of the LBNL system.  If you are using a laptop or other remote-access device, the machine will need to be part of the LBNL Virtual Private Network (VPN).  More information and downloads available at:  http://www-lblnet.lbl.gov/vpn.html .
To start a new protocol:  Navigate to your personal Home page.  On the far left hand side, in the pale grey margin, click on the command button to Create New Human Protocol.   This will take you to the first page of the human subjects protocol smartform.  Please be aware that the new protocol will not be saved in the system until the first page is completed and saved.

To open a new renewal/continuing review:  Navigate to the protocol workspace.  Then, click on the Create "New Continuing Review" activity button, which is located at the bottom of the far left hand column.   This will open a new renewal/continuing review smartform.  Please be aware that the smartform will not be saved in the system until the first page is completed and saved.

To close out a protocol: The Closeout/Final report is a subset of the renewal/continuing review smartform.  Please log on to the HARP system and navigate to the protocol workspace, then: 
1)  Click on the Create "New Continuing Review" activity button, which is located at the bottom of the far left hand column.   This will open a new renewal/continuing review smartform.  
2) At the bottom of the first page of the smartform, under 11.0 - Type of Review, select "Closeout/Final." Remember that like all the smartforms, this one will not be saved in the system until the first page is completed and saved.
To open a new amendment:  Navigate to the protocol workspace.  Then, click on the Create "New Amendment" activity button, which is located at the bottom of the far left hand column.   This will open a new amendment smartform.  Please be aware an amendment consists of two parts:  the ‘Amendment’ itself, which is a cover sheet smart form  in which you tell the Committee what you are changing, and the Modified Study,  a copy of your protocol in which the changes are actually made.

How do I review and Submit something in HARP?   You must be the Protocol Lead Investigator (PLI) on the item (e.g. a Continuing Review or Amendment).  Navigate to your Home Page.  On your home page, in just about the middle of the page, you will see any items that are in a state that requires your attention (such as Pre-Submission, or Changes Required).   Click on Title of the Item to go to that item’s workspace.  
1)	In the upper left hand corner of the workspace, you will see a goldenrod box that tells you the Current State.  
2)	Directly under the goldenrod Current State box you will see a button for Edit Continuing Review or Edit Amendment; click on that to review/edit the submission.
3)	Further down under that goldenrod box you will see a short list of My Activities.  (In the HARP system, activity buttons are always found on the far left hand side of the workspace.)
4)	Look for Submit Renewal [or] Submit Amendment.  Click on that button and follow the instructions.

To check on the status of a protocol, amendment, or renewal/continuing review/closure report that has already been submitted:  You can check on the review history of any submission by navigating to the submission’s workspace.  The current status of the review is indicated by the yellow-orange field in the upper left hand corner of the workspace.

To find out if someone else already has an account in the HARP system, or to determine if they are the someone you think they are:   use the Activity Edit Protocol Access.  Like all activities, this can be found on the left hand side of the protocol's workspace.  It is available to Protocol Coordinators,  PLIs and co-PLIs.  (Responsible Staff have a similar activity called Edit Email List available to them.)  Click on the activity, and either type the first few letters of the individual's last name in the box or click on the Add button to see the full list of folks in the system.   Once you've selected the person you are interested in, their name, organization and actual e-mail will show up.

To amend your personal Profile in the HARP System:  When you first log on to the HARP system, you will find yourself in your Home page.  Just above the middle of the page, you should see a series of gray tabs:  Inbox, IRB, etc.  Click on the Profile tab, then click on the red   <Your Name's> Profile link.  This will open your profile.  Click on the Edit Researcher Profile activity in the upper  left, and you can amend just about anything in there except human subjects-specific training.

PROTOCOL ROLES AND RESPONSIBILITIES  
I have a collaborator or staff member who does not work at LBNL and whose participation is limited to analysis of identifiable data off-site. How should they be listed on my protocol?  They may be listed as Other staff, with their ‘role on study’ defined as Off-Site Collaborator –data analysis.
I have a collaborator at another UC campus that distributes recruitment flyers on their campus and refers interested potential subjects to the Lab. What do I need to do on my protocol?  They may be listed on the HARP protocol in section 7.0, Staff, with their ‘role on study’ defined as Off-Site Collaborator.  Their campus IRB should be notified of their participation in your research through a Notice of Intent to Rely, which requires an entry in the UC IRB Reliance Registry and a reference on your LBNL protocol. 
I have a collaborator who performs no work at LBNL, but whose contribution I want to acknowledge by designating them as a ‘co-Lead Investigator’.  How do I do that?  Please note that they must have an account, but they will not have even read-only access to HARP unless they have LBNL guest status and an LDAP.  (As of 4/1/2011, this is a security provision of HARP that we cannot change.)  As co-Leads, they will receive HARP automated e-mails but they will not be able to respond to them.
I have a collaborator at another University of California (UC) campus who recruits, screens, consents, and performs preliminary blood-pressure testing on subjects before they come to LBNL for further participation.  Such collaborators should be listed as Responsible Staff or co-Lead Investigator.  You will have to request an account for them and their UC campus IRB should be notified of their participation in your research through a Notice of Intent to Rely, which requires an entry in the UC IRB Reliance Registry and a reference on your LBNL protocol.  They do not need to take EHS0740 Human Subjects Research Training Program because their training requirements are set by their home institution.
I have a collaborator at a non-UC, federally-assured educational or research institution (i.e., an institution with a DHHS Assurance of Compliance) who recruits, screens, consents, and performs preliminary blood-pressure testing on subjects before they come to LBNL for further participation.  Such collaborators should be listed as Responsible Staff or co-Lead Investigator.  You will have to request an account for them.  Please be aware that their local IRB may require a separate protocol filing, that it is up to them to determine what the requirements of their home site are, and that the Human Subjects Committee may require documentation that those local requirements have been met.  They either need to take EHS0740 Human Subjects Research Training Program or provide documentation of equivalent training (e.g., CITI certification, or proof of completion of a locally-presented course).
I have a collaborator at a non-UC, federally-assured educational or research institution who recruits, consents, and surveys subjects using an instrument developed at Berkeley Lab.  All subject participation takes place off-site.  The protocol for the research should be filed with the Institutional Review Board at the institution performing the research.  Once approved, you should apply for an Expedited Verification Assessment through the HARP system.  Your colleague will not require a HARP account.
I have a collaborator or contractor who is not an employee of an institution with a federal-wide assurance.  This individual recruits, consents, and surveys subjects.  All subject participation takes place off-site.  
Such individuals should be listed on the protocol as some form of responsible staff.  You will have to request an account for them.  At a minimum, they need to take EHS0740 Human Subjects Research Training Program or provide documentation of equivalent training; additional training may be required.  In addition, they must fulfill the requirements in (1) or (2), below:
(1) Single individuals must complete an Individual Investigator Agreement for co-signature by LBNL’s Institutional Official.  (An IIA template is available from the HARC office or through the HSC website.)  Because they are performing ‘responsible’ tasks on behalf of LBNL and without any other institutional authorization, they must have LBNL guest/affiliate status and an LDAP.  
(2) Individuals associated with corporations, consulting firms, or 503(c) non-profits: The entity with which they are associated must obtain a Federalwide Assurance of Compliance assigning LBNL as the IRB of record.  At the discretion of the Human Subjects Committee, the entity may be asked to designate a single individual to serve as Responsible Personnel on the protocol, but will individually assure that each person in their employ working on the research has been appropriately trained.  The entity will maintain a separate record of their employees’ training and will provide it to the HSC upon request. 
An IRB Authorization Agreement (IRBAA) detailing the entity’s acceptance of these responsibilities must be submitted for co-signature by LBNL’s Institutional Official. (An IRBAA template is available from the HARC office or through the HSC website.)

I have a Proposal Specialist or administrative assistant who needs to be able to check on my protocol expiration dates.  Proposal Specialists or other administrative staff may be listed as on the protocol as Staff, with their ‘role on study’ defined appropriately.  Remember that they must be registered in the HARP system before you can add them to your protocol.  (E-mail harc@lbl.gov with their LASTNAME, Firstname Middlename, Organization, and e-mail address and ask to have them input as Staff.)  To add them as Staff or should your specialist change you will need to submit a ‘Staff Change Only’ amendment.