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?  (46.102(e)) A living individual about whom an investigator (whether professional or student) conducting research: 
1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains uses, studies, analyzes, or generates identiﬁable private information or identiﬁable biospecimens.
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 Chair: Antoine Snijders (x7235 or amsnijders@lbl.gov).
Where do I find the online training program that I must take before being listed on a protocol or working with human subjects?  All human subjects researchers will need to complete the CITI training specific to your type of research (i.e. Biomedical OR Social, Behavioral, and Educational). See the Training page on our website for more information. (https://commons.lbl.gov/display/harc/Training+in+the+responsible+use+of+human+subjects)

Do I need to renew my human subjects research protocol if I am no longer using it?  
Yes! Your protocol 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. 

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. Responsible personnel who perform work at Berkeley Lab or a Berkeley lab research site must have an LDAP. 

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

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.  
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 the LBNL required training 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 CITI training through the “Other DOE” affiliation 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 responsible staff.  You will have to request an account for them.  At a minimum, they need to CITI training 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 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.  (Complete the account form and send to harc@lbl.gov)  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 (IIA)?
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 CITI training 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 IIA and the contract or statement of work negotiated 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 IIA, 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 IIA to the HARP protocol, annotating it as ‘Final.’ 

How do my collaborator and I set up an IRB Authorization Agreement (IRBAA)?
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 IRBAA using the template available on the HSC website.  The completed draft IRBAA 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.’

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?  Maybe, 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”).

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)