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
IAA  is the acronym for Individual Investigator Agreement, a formal agreement under which an collaborator not affiliated with an institution holding an Assurance of Compliance may ask to be covered by LBNL’s Assurance.
IRB  is the acronym for Institutional Review Board, the generic name for an internal board that reviews human subjects research.
IRBAA  is the acronym for Institutional Review Board Authorization Agreement, a formal agreement under which one IRB agrees to provide the IRB review for another institution.
PLI  is the acronym for Protocol Lead Investigator, the lead researcher on a human subjects or animal welfare research protocol.  

GENERAL INFORMATION

What is the Berkeley Lab Assurance of Compliance (FWA) number? FWA 00006253 
What is the IRB registration number?  IRB #00006447  
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?  If your project is a systematic investigation meant to produce generalizable knowledge and involves human participants or human derived data, please call the HARC Office at 5399 for an initial consultation.  If questions remain, please refer the issues to the HSC Chairs: Scott Taylor (x4545) and Antoine Snijders.
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 Berkeley Lab Training site under EHS740.   
( http://www2.lbl.gov/ehs/training/webcourses/EHS0740/ )
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.  Anyone can go to the Berkeley Lab Training site ( training.lbl.gov ) and complete EH&S 740 training.  After finishing, they’ll be given the option to register using their name and a non-LBNL e-mail.  The training system will send them a completion e-mail that can be saved and forwarded to the HARC office as proof of training.

Do I need to renew my human subjects research protocol if I am no longer using it?  Yes! 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 Continuing Review activity.  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 the HARP Account Request Form and e-mailing it to harc@lbl.gov.
(2)	Take basic human subjects training (EH&S 740).   http://training.lbl.gov/ 
(3)	(Optional) call the HARC office (x5399) and schedule a personal HARP 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 ldap, 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.
Why do I keep getting email reminders of approaching expiration even though I have already submitted my protocol renewal?   The system will keep sending reminders until the renewal has been approved.  This is to help prevent the protocol from expiring while in a state requiring action by you or the HSC.   
How can I check on the status of my renewal?  You can use the link in any reminder e-mail; just click on the Pro000##### link in the e-mail, which will take you the to master protocol's workspace.  From there, look under the history log for a reference to Renewal Opened; under that you will find an icon with a pad and pen next to a link to View Continuing Review workspace.  That link will take you to the status page for the renewal, where you can check the yellow-orange status box in the upper left of the screen. 

How do I review and Submit something in HARP?   You must be the Protocol Lead Investigator (PLI) on the item (e.g. a Protocol, 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 cancel, delete, remove, or withdraw a not-yet-approved (pending) protocol, amendment, or renewal/continuing review/closure report:  Navigate to the workspace for the item you wish to cancel or delete.   Look on the far left hand side of the screen (under the yellow-orange status field) for a list of My Activities.   Click on the Withdraw Activity, and follow the instructions in the window that will pop up.

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 add or remove Responsible Staff, you need to open a new Full amendment.

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 take you to the workspace for 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  
Additional Information on Accounts, Profiles, Roles and Responsibilities
Responsible Personnel include the Protocol Lead Investigator (PLI), any co-Lead Investigators, the study coordinator(s), the faculty sponsor (if applicable), and any additional personnel with responsibilities for the design, conduct, and or reporting of the research. All Responsible Personnel who perform work at Berkeley Lab or a Berkeley Lab research site must have an LDAP and take either EHS0740 or equivalent training

What is a Protocol Lead Investigator (PLI)?  The lead researcher on a protocol (as opposed to a proposal), this individual has ultimate responsibility for the conduct of the work described in the protocol.   In the HARP system, the PLI is the only one who can certify and submit a research protocol, protocol renewal, or amendment.   There can be only one per protocol, and must have an LDAP ID and at least LBNL Affiliate (Guest) Status.
Co-Protocol Leads (co-PLI) 
•	Can create, edit, and read protocol submissions (if they have an LDAP account)
•	If the PLI is a masters or doctoral candidate and a faculty sponsor with a joint appointment at LBNL will oversee this research, the faculty sponsor should be listed as a co-Protocol Lead. 
Protocol Coordinator(s)
•	Can create, edit, and read protocol submissions
•	It is recommended that only one coordinator be named per protocol unless your group has procedures or agreements in place to prevent one coordinator from overwriting the work of another.
Additional Responsible Personnel 
•	Read-only access to protocol submissions (if they have an LDAP account)
•	Do work directly with subjects performing functions such as drawing blood, inserting catheters, administering consent, or conducting interviews 
Staff 
•	Read-only access to protocol submissions (if they have an LDAP account)
•	May perform tasks such as scheduling appointments, distributing study instruments, or analyzing identifiable data
•	Do not require EH&S 740 training, Responsible Conduct of Human Subjects Research
•	Do not need a HARP account, but must be registered as a contact.  To have a contact added to the Click system, e-mail harc@lbl.gov requesting that they be added as a contact and providing their LASTNAME, Firstname Middlename, Organization, and e-mail address

ROLE AND RESPONSIBILITY FAQs
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.  Other staff do not have to take human subjects training, nor do they have to answer questions with regard to their financial interests.
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 need to either take EH&S 740 Human Subjects Research Training through the Lab’s Training page 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 (IIA) 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, then complete an IRB Authorization Agreement and submit it for counter-signature by LBNL’s Institutional Official.    
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.  LBNL-supplied training (see Training below) may be used to satisfy this requirement. 
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.
Do I need to be on staff at LBNL to be the Protocol Lead Investigator?  Not necessarily; it may be sufficient for you to have LBNL Affiliate (formerly known as Guest) status.  Please contact your Lab sponsor to ensure that your Affiliate status has been approved before submitting a protocol.  
I am a UC researcher; can I conduct a study in the Building 90 environmental chamber?  The FlexLab?  The Building 55 MRI?  Yes, so long as you have (1) the permission of the facility owner or manager; (2) qualifications and experience appropriate to your role on the protocol, as evaluated by the LBNL Human Subjects Committee (HSC);  and (3) either LBNL Affiliate (formerly Guest) status or an LBNL colleague who will act as protocol lead.  The protocol must be approved by the LBNL HSC, as the HSC cannot rely on an outside IRB for research conducted on site.  

SPECIAL CASES
How do my collaborator and I set up an Individual Investigator Agreement (IAA)?
1)	The role of the individual conducting research on behalf of the Lab must first be described in an approved protocol filed in the HARP system.  At a minimum, they need to take EHS0740 Human Subjects Research Training Program or provide documentation of equivalent training; additional training may be required.  Because they are performing ‘responsible’ tasks on behalf of LBNL and without any other institutional authorization, Lab policy may require them to have guest/affiliate status and an LDAP; please check with your division.
2)	The Protocol Lead Investigator and the individual should then complete an Individual Investigator Agreement (IIA) using the template available on the HSC website.  The completed draft IAA and the contract or statement of work negotiated with between LBNL and the individual is then submitted to harc@lbl.gov for forwarding to the Institutional Official (IO).
3)	The HARC staff checks the draft IIA for completeness, and to verify that the agreement cites the correct FWA number for the relying institution and the appropriate human subjects protocol.  Problems and/or incomplete IIAs will be referred back to the Berkeley Lab Protocol Lead Investigator for resolution.  The PLI and the relying individual are expected to fully understand the terms of the agreement, and take direct responsibility for ensuring that the terms are met.
4)	The draft IAA, the SOW/contract and the protocol itself are converted to PDF by the HARC staff and then e-mailed to Office of Institutional Assurance for transmittal to the IO. 
5)	Once signed, the IO’s office sends the original back to the Protocol Lead Investigator, with a copy to the HARC office and OIA.  HARC then uploads the signed IRBAA to the HARP protocol, annotating it as ‘Final.’ 

How do my collaborator and I set up an IRB Authorization Agreement?
1)	The relationship with the corporation, consulting firm, non-profit or other external entity conducting research on behalf of the Lab must first be described in a protocol filed with the HARP system.  
2)	Once the protocol is approved (or is nearing approval), the external entity can file for a Federalwide Assurance of Compliance (FWA) assigning LBNL as the IRB of record on the Office of Human Research Protections website (http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html ).  
3)	After the FWA has been awarded, the Protocol Lead Investigator and a representative of the entity should complete a draft IRB Authorization Agreement using the template available on the HSC website.  The completed draft IRB Authorization Agreement and the contract or statement of work negotiated with between LBNL and the entity is then submitted to harc@lbl.gov for forwarding to the Institutional Official (IO).
4)	The HARC staff checks the draft IRBAA for completeness, and to verify that the agreement cites the correct FWA number for the relying institution and the appropriate human subjects protocol.  Problems and/or incomplete IRBAAs will be referred back to the Protocol Lead Investigator for correction.  The PLI and the relying entity are expected to fully understand the terms of the agreement, and take direct responsibility for ensuring that the terms are met.
5)	The draft IRBAA, the SOW/contract and the protocol itself are converted to PDF by the HARC staff and then e-mailed to Office of Institutional Assurance for transmittal to the IO.  
6)	Once signed, the IO’s office sends the original back to the Protocol Lead Investigator, with a copy to the HARC office and OIA.  HARC then uploads the signed IRBAA to the HARP protocol, annotating it as ‘Final.’

To have an account/profile set up, please submit the information in the following form via e-mail to harc@lbl.gov . 
First name		
Middle name or initial (needed for unique internal identifiers) 		
Last name		
Email address (or addresses)		
Organization (if LBNL, also provide  Division name)		
LBNL employee ID number		
Phone number 		
Roles:	Protocol Staff/Responsible Personnel		(all individuals with profiles will automatically be assigned these roles)	
	Protocol Lead Investigator (PLI)		
	Co-Protocol Lead (Co-investigator)		
	Protocol Coordinator		
Required Last completed LBNL Human Subjects Research Training EHS 740 on:		
Optional CITI IRB Training Tutorial completed on:		
Optional Blood Borne Pathogen training completed on:		

Special Considerations
Compensating research participants
Can I offer a cash or prize incentive to research participants who are employees of Berkeley Lab? The Human Subjects Committee would have no objection and in fact encourage offering Lab employees the same incentive as any other participant for participation that occurs outside of normal working hours.  However, other offices at Berkeley Lab have prohibited payments to Lab employees.  Please contact your divisional Financial Officer for clarification.
Can I use a lottery to incentivize research participation?  Yes, but researchers must be aware of California state law in this area.  The following was excerpted from the U. C. San Diego Recruitment and Advertising Guidelines for human subjects research:
According to the California Department of Consumer Affairs, “California law prohibits lotteries. A lottery is any scheme for the disposition of property by chance among persons who have paid or promised to pay any value for the chance of obtaining the property, with the understanding that it will be disposed of by chance.” There are three exemptions to this prohibition including the California State Lottery, bingo for charitable purposes and a raffle conducted by a non-profit, tax-exempt organization for charitable purposes.
 “Courts have used certain rules to decide whether a scheme includes consideration because it is not always clear. If a person is eligible to win a prize without purchase, there is no consideration and the contest is legal. In such a case, if some people may pay money - for example, an admission charge or a product - there is not necessarily consideration if other people may enter without such a purchase (emphasis added).  If eligibility to win a prize is limited to those who have paid money, however, there is consideration. Alternatively, if some persons must pay in order to have a chance at a prize while others do not, there is consideration.”   Being required to complete the research participation in order to 'earn' a lottery chance is a form of consideration. In addition, there is concern that most people overvalue their likelihood of winning, and therefore, offering a valuable prize may serve to undermine the process of informed consent. In light of this information, the Human Subjects Committee will decide on a case-by-case basis  if lotteries, raffles, and/or drawings may be used to recruit or retain participants.   
In order to ensure informed consent and avoid violating California state law, researchers should  include all the following elements in the lottery-like research compensation plan and associated consent forms: 
a) A procedure to ensure that any individual who is asked to participate in the research study but declines, who consents/assents to enroll in the study, or who fails to complete the study, will be given equal compensation by having an equal chance of winning. In other words, if an individual is eligible to participate in the study, and therefore the lottery, raffle and/or drawing, they do not have to participate in the study to be eligible to participate in the lottery, raffle, and/or drawing; 
b) A procedure for inclusion of an individual who is not asked to participate in the study but wishes to be included in the lottery, raffle, and/or drawing; 
c) A fair method of choosing the winner and an explanation of how the winner will be notified; and 
d) A disclosure of the approximate chance of winning (e.g., “No less than 1 in 1000”).

Using the University of California Reliance Registry
If you are the Reviewing Campus Principal Investigator (PI) or Research Coordinator (RC), Request a New Reliance:
1.	If you have not already done so, register as a Registry User by going to http://irbreliance.ucop.edu  and click on User sign up under “Register”. Complete the "User Registration" form.
2.	Click Create Request tab.  One of the first questions asks whether or not your study involves the Veteran’s Administration; please answer ‘no’ The UC IRB MOU applies only to UC campuses and the Lawrence Berkeley National Laboratory.
3.	Identify your role in the study. Be prepared to answer all of the questions marked with the red asterisk. You can complete the form in a few sessions if you make sure you save each of your entries.
4.	Enter contact information for the Relying Campus PIs. The Registry will send each PI an e-mail invitation to register and sign up for the study. Once all of the invited PIs have registered their participation, you will be able to sign the Request form. The Office of the President notes:
"Prior to signing this form, you may want to check with the [LBNL HARC Office] if all entered information is correct, and make appropriate changes BEFORE signing the assurances at the bottom of the form. At this time, the IRB Reliance Registry does not allow [you to edit] after you declare that the information entered is correct by signing off on the form."
5.	Once the LBNL IRB approves your study, the HARC Office will enter the study's approval expiration date in the Registry as well as upload the approval letter and other materials as needed. You will receive an e-mail from the Registry informing you that these procedures have been done and you will be able to review all of the uploaded documents for any study you are associated with in the Registry.

Continuing Review, Submitting Amendment and Reporting Adverse and Unanticipated Events when LBNL is the Reviewing Site
1.	You should submit the usual request for Continuing Review of your human use protocol through the HARP system approximately 45 days prior to expiration date of the study.
Once the Continuing Review has been approved, the LBNL HARC Office will update the expiration date in the Registry. The Office of the President notes: "... no relying UC site on your study will be able to continue work if you don't obtain IRB renewal [continuing review approval] on time: it is your responsibility as a Reviewing Campus PI to apply for the renewal [continuing review] on time!"
2.	You are responsible for submitting amendments, adverse events and unanticipated problem(s) involving risk to subject or others to the LBNL HSC through the HARP system — regardless of whether they are related to the LBNL site or to a Relying Campus. The Relying PIs/RCs are required to promptly inform you of all such events and you will submit those through the HARP system as usual, not using the Registry. Results of the review of these submissions will be provided to you and uploaded into the Registry by the HARC Office.

If you will Rely on a Study using the Registry
You must have a Registry account in order to be added to a Reliance as a relying PI (principal investigator).  Your collaborating Reviewing PI should contact you if you need to open a Registry account. Go to http://irbreliance.ucop.edu,  click on "Register" and complete the "User Registration" form.
Once you receive an e-mail invitation from the Registry noting that you have been identified as a relying PI or RC (research coordinator):
1.	Follow the instructions provided in the e-mail to access the Registry.
2.	Be prepared to answer all of the questions marked with the red asterisk. You can complete the form in a few sessions if you make sure you save each of your entries.
3.	Register your participation as soon as possible. Only after all of the invited Relying PIs have registered their participation can the Reviewing PI sign the Request form, which is needed as part of the submission to the Reviewing IRB. A delay in responding to the e-mail invitation to register your participation will further delay the IRB review. 
4.	Complete a short protocol in the LBNL HARP system. (Call the HARC office if you need help.) [Should we add that this will typically be an expedited protocol? An EVA?]
5.	Once the Reviewing campus IRB approves the study, they will enter the study's approval expiration date in the Registry as well as uploading the approval letter and other materials as needed. You and the HARC Office will receive an e-mail from the Registry.  The LBNL HSPP will then review all of the uploaded documents and decide whether to accept or decline to rely on the Reviewing Campus IRB review. If LBNL agrees to rely, we will upload an acceptance letter to the Registry and the reliance will be complete.

Continuing Review, Submitting Amendment and Reporting Adverse and Unanticipated Events
1.	You are required to promptly inform the Reviewing PI/RC of the need for amendments. You are also required to report to the Reviewing PI/RC and the LBNL HSC any adverse or unanticipated events at the LBNL site. The Reviewing PI is responsible for notifying the Reviewing Campus IRB following the Reviewing Campus's guidelines and using the Registry. Any decision, change in protocol, etc. will be reported and uploaded to the Registry by the Reviewing Campus IRB.
2.	Continuing Reviews (Annual Reviews) are the responsibility of the Reviewing PI. If the Continuing Review approval is not obtained in a timely manner, none of the relying sites will be allowed to continue research. The Reviewing IRB will update the Registry once the Continuing Review approval has been granted, and the Registry will notify the Relying IRB and investigator(s)

For more information, please contact the HARC Office at x5399 or see the Reliance Registry Help tab at:  https://irbreliance.ucop.edu/site/help

FAQs and Advice for HSC members
Three general tips for using the HARP system as a reviewer:
1)	The link in the e-mail you receive designating you as the Primary or Secondary reviewer (for a review at a Committee meeting) or Designated Reviewer (for exempt/expedited reviews) will take you to the 'workspace' for the protocol. 
2)	The activities that are available to you will be listed on the left hand side of the workspace.  They include ways to contact the researcher (Send Email to Protocol Team) and/or your HSC colleagues (Send Email to Committee members)
3)	Remember to 'right-click' to open things in a new tab  --very helpful for jumping back and forth

Pete Lichty's Top Three Tips for reviewing a new protocol:  
1)	On the protocol's workspace, right-click on the pale gray Reviewer's Note tab to see past correspondence --you'll find any exchanges with the investigator and questions from staff recorded here;
2)	On the protocol's workspace, right-click on the pale gray Attachments tab in the middle of the screen and open all the attachments in separate tabs
3)	Convert the protocol document to text (either Print to PDF, or copy into Word --the latter makes it easier to adjust text size) so you have a text version to work from.  Particularly helpful if you have two screens to work with!

Chris' Top Three Tips for performing any review:
1)	Please use Reviewer Notes to leave comments  --they are anonymous to the researchers, but make processing change requests much easier for staff; 
2)	Compare the consent form to the checklist and make sure it is fully consistent with the protocol;
3)	On expedited reviews, select the correct vote type  --if you want even the smallest change, please use the vote type, "Request Changes/Clarifications."

General Hints for Reviews:
1)	Remember that staff review is primarily to ensure completeness;  while they may draw your attention to other issues we note, please don't assume they have performed a full review; 
2)	Final authority for determining that a protocol/amendment is expeditable lies with the designated reviewer, so reviewers should familiarize themselves with the policy (link below);
3)	For renewals and amendments, look for the breadcrumb trail in the upper left in order to go back to the current mother protocol.  Remember to right-click so it opens in a new tab!

How can I see the changes that have been made in an Amendment?
How do I see what is changed when a protocol is re-reviewed?
Method A:
1)  Go to the Amendment Workspace.
2)  Under the goldenrod 'status' box, there are two groups of clickable function boxes.  The first set of three applies to the amendment cover sheet; the second set to the modified study (the changed version of the protocol).  Click on View Changes, which on my screen is the last one in the second set.  
3)  After the screen refreshes, Click on View Differences;
4)  Use the pull-down menu to select the earliest available version;
5)  Use the >> double arrow keys to step through the changed pages (and only the changed pages)

Method B:
1)  Go to the Amendment Workspace.
2)  Under the goldenrod 'status' box, there are two groups of clickable function boxes.  The first set of three applies to the amendment cover sheet; the second set to the modified study (the changed version of the protocol).  Click on View Changes, which on my screen is the last one in the second set.
3)  This takes you to a page displaying the Change Log, which is a listing of all the changes made since this amendment was opened.  The page changed is identified in each log entry.  You will likely see that some of the pages were changed more than once; you'll want to look at the most recently changed (dates on the right) by clicking on the links with the icon of a pad and pencil next to them.  This will take you to a cool side by side of the Currently Approved page to the Proposed Modifications.

How do I leave a Reviewer Note?
1)	Navigate to the application under review.
2)	On each page of a protocol  or a renewal or continuing review cover sheet, look in the green or buff band in the upper left hand corner for  Reviewer Notes .
3)	Click on the triangle in the circle to reveal Reviewer Notes already posted.  Click on the word ‘Add’ next to  Reviewer Notes in order to add a note; remember to select IRB Private Change Request.
4)	Add your Reviewer Note; Word functions such as bold, italics, etc are available to you, and click on ‘OK’ before exiting.

How do I indicate that I plan to attend a meeting?
1)	Look in your notice from "HARC@lbl.gov" for the link to the meeting. ( If you did not receive a notice, please check your spam before contacting Suresh Tunugutla, sktunuguntla@lbl.gov)
2)	If you received the e-mail please try to log on the system, confirm your attendance and look at the agenda.  (To log on, you must be working from an LBNL on-site computer, or one with LBNL's Virtual Private Network (VPN) software installed and activated.  See https://commons.lbl.gov/display/itdivision/VPN+-+Virtual+Private+Network for more information.)
3)	To confirm attendance, look for the green “thumb’s up” button on the left hand side of the agenda workspace and click on it (or the red “thumb’s down” to decline).

Links to Policies and Guidance:

Belmont Report and Principles  --the ethical principles LBNL cites in its Assurance of Compliance ( http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html )

Expedited review  --see Expedited Protocol Review Process       (on https://commons.lbl.gov/display/harc/Policy+and+Procedure+Documents)

Conditions for approval --see Criteria for the Approval of Human Subjects Research   (on https://commons.lbl.gov/display/harc/Policy+and+Procedure+Documents)