FREQUENTLY ASKED QUESTIONS 
HSC MEMBERS EDITION

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  

RESPONSIBILITIES OF MEMBERSHIP (9/2017)

 Completing initial training as directed by the Chair following appointment; 
 Attending scheduled meetings, with regular members expected to attend at least 50% of all scheduled meetings, and alternates at least 25% annually; 
 Notifying the HSC administrators promptly when unable to attend a meeting or perform a requested review; 
 Reviewing all materials distributed with the meeting agenda prior to scheduled meetings;
 Revealing and avoiding conflicts of interest that could be perceived to impact the independence of their decision making, such as:
o Financial interests in projects brought to the Committee for review; members should recuse themselves from votes on research in which they have a financial interest.
o Research or managerial interests in protocols that come before the Committee; again, members should recuse themselves to avoid even the appearance of a conflict.  This includes situations where:
--The member is staff on the protocol
--The member shares joint research interests and relationships with the protocol lead investigator(s) and/or co-protocol lead(s)
--The member supervises or is supervised by the protocol lead investigator(s) and/or co-protocol lead(s) 
 Participating as primary or secondary reviewers or conducting expedited reviews when requested by the Chair, Vice chair, or HSC administrators; and 
 Performing other HSC-related activities when requested by the Chair, Vice Chair, or HSC administrators.

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 .

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

Peter 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)