Wabanaki Research Review Board
Wabanaki Public Health and Wellness
06/10/18
Kulasihkulpon!
We welcome you!
Welcome to the Wabanaki Research Review Board Interactive Educational Toolkit!
This toolkit is designed to guide you through the details of research review boards. The toolkit is divided into five sections, feel free to explore at your own pace. Each section ends with a review in either the form of a quiz or a game.
Kisac?
This toolkit was created by Jillian Worster, Passamaquoddy Tribe
INDEX
In case you need a break, this page is an easy navigational tool to select a new section.
Wabanaki Research Review Board
Establishing a Research Review Board
WRRB Membership
AdditionalResources
RRB Review Process
01
Wabanaki Research Review Board
What are tribal research review boards?
Wabanaki Research review board (WRRB)
The Wabanaki Research Review Board (WRRB) is a committee that reviews research proposals to be conducted on Wabanaki Citizens, or within Tribal Territories or where Wabanaki citizens are the subject of data collection.
- The WRRB has the authority to approve, disapprove or require modifications to these research projects.
- The WRRB reviews the proposals to ensure the research project follows the ethical principles and federal regulations for the protection of human subjects.
Why have a Tribal Research Review Board?
What is a Tribal Research Review Board?
A tribal research review board is a group of individuals that have interest in ensuring tribal members and the tribal community are receiving the most from a research project and are willing to volunteer time to review a lot of written materials.
It is important to have a tribal research review board to ensure tribal members and the tribal community are protected, from a tribal perspective, and have optimal benefit from a research project.
Info
+ info
BENEFITS OF A RESEARCH REVIEW BOARD
Why do we need a research review board?
Allows for greater and more consistent protections for the community
Saves time for the Tribes and the investigator, making the research review process more efficient
Facilitates dedicated time and effort to research review process, including training of board members
Creates clear guidelines and contracts for collaborations between researchers and the tribes served
Option to utilize external consultants, who are also Wabanaki citizens when field-specific expertise needed
What kind of research projects does the RRB review?
WRRB is charged with reviewing all research projects involving human subjects and will expand their scope to include research conducted within Tribal Territories, papers, and presentations about Wabanaki Citizens. In addition, they will also review any publications that include Wabanaki data.
Importance of research
Defining Research
Research is a process to answer a question, gain knowledge, or search for a solution to a problem.
Tribally Driven Decisions
Self-Determination
Research outcomes can drive decisions essential to tribal citizens. Knowing how to best gather new research data is crucial.
Tribes can exercise their right to self-determination through determing what research is done in their communities and prioritizing topics vital to tribal citizens. Research must benefit tribes and support positive change.
Where does an rrb get its authority?
RRB'S AUTHORITY
The WRRB applies to initially establish a review board as well as ongoing application for continuation.
01
In 1974, the Department of Health Education and Welfare promulgated the regulations on the Protection of Human Subjects known as the Belmont Report Review Boards are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services.
OHRP assists in their work including receiving and investigating claims of inappropriate research practices.
02
The WRRB provides administrative support for its activities including designation of an individual within the institution to oversee research and functions.
03
Info
6 FAQ'S
on IRB Fee Scheduling
Is there information on fees charged by other American Indian Tribal IRBs?
Should Tribal IRBs Charge Fees?
IRB FEE SCHEDULE
Should there be a policy for billing and and collection of IRB fees?
Should IRB charge for 'initial review', 'continuing reviews', and 'amendment review'?
Can research investigators use grant funds for IRB fees?
Should there be waivers or reductions of review fees?
can a Tribe be an
'institution' as defined
by ohrp?
Yes. Tribes are often treated as "public entities" or referred to as "tribal entities". * For those who consider a Tribe or Tribal department to be a non-U.S. institution, the OHRP guidelines regarding non-U.S. institutions are as follows: "Whenever non-U.S. institutions are engaged in non-exempt HHS-supported or conducted human subjects research, the regulations apply."**
How does an rrb protect special populations?
The Code of Federal Regulations requires that WRRBs give special consideration to some classes of subjects: children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons.
In many cases, the WRRB may approve of research with these subjects only when it involves minimal risk or when the benefits apply to the subject directly.
Info
Who has access to rrb records?
The institution and the WRRB maintain records of WRRB activities including copies of the research protocols reviewed, minutes from meetings and correspondence.
Records of the work conducted during a review are not available to the public. All records must be made available for review by OHRP.
Questions to Ask When Considering an RRB
Are researchers coming to our tribal community to introduce research projects?
What type of research is being proposed? For example, surveys, interviews, screenings, etc?
Who is being involved within the community? Existing programs, community at large?
Who should serve on the review committee?
How do we support the review committee?
Research Review Board
Institutional Review Board
s.
- Established to ensure responsible research in Tribal Communities
- Increase the capacity for Tribes to reduce community and individual harm
- Provides oversight for ALL studies conducted on Tribal territories
- Reviews all research for community risk and benefit
- Ensures cultural competency of researchers
- Utilize Tribal best practices to guide the design of studies
- Committee that performs ethical review of proposed research involving human participants.
- Concerned with protecting the welfare, rights, and privacy of human subjects.
- Has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction.
Research Review Board
Institutional Review Board
s.
- Established to ensure responsible research in Tribal Communities
- Increase the capacity for Tribes to reduce community and individual harm
- Provides oversight for ALL studies conducted on Tribal territories
- Reviews all research for community risk and benefit
- Ensures cultural competency of researchers
- Utilize Tribal best practices to guide the design of studies
- Committee that performs ethical review of proposed research involving human participants.
- Concerned with protecting the welfare, rights, and privacy of human subjects.
- Has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction.
University Research Review Boards are called...?
Research Review Board✔
Institutional Review Board✔
Congratulations!
Kuli-kiseht! Good Job!
University Research Review Boards are called INSTITUTIONAL REVIEW BOARDS (IRBs)
TRY AGAIN?
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apc qetonahkane! Let's TRY AGAIN!
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BACK
02
WRRB MEMBERSHIP
What are the requirements and qualifications of WRRB membership?
Members must have the professional experience to provide appropriate scientific and ethical review.
Consists of eleven (11) voting members of varying backgrounds.
Membership
The WRRB strives for appropriate representation in gender, racial and cultural heritage.
There must be at least one member who is not otherwise affiliated with the institution (a community representative).
At least one member must be a member of the scientific community and at least one member whose primary concerns are nonscientific.
RESPONSIBILITIES OF WRRB MEMBERS
Attend meetings regularly to ensure quorum.
Complete training on human subjects’ protections regulations and research review processes.
Actively Participate in WRRB meetings and offer expertise for the ethical review and monitoring of research.
Review research protocols and documents prior to the scheduled meeting.
RESPONSIBILITIES OF WRRB MEMBERS
Notify their alternate if they are unable to attend a scheduled meeting
Inform coordinator in the event of a conflict of interest for a research protocol.
Maintain strict confidentiality regarding research protocols and IRB proceedings.
Members
There are some key members to an RRB with specific roles
Principal Investigator (PI)
Institutional Officer (IO)
Research Review Board Coordinator
Members
There are some key members to an RRB with specific roles
Principal Investigator (PI)
Institutional Officer (IO)
Research Review Board Coordinator
Qualifications
There are certain qualifications for WRRB members to be mindful of...
Duration Length of Term
Non-Scientific Members
Meetings and Time Committment
Scientific Members
Non-affiliated Members
02
What is a Principal Investigator?
the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research
Is the individual legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance.
The individual who's role is instrumental in the design and set-up of infrastructure for the review and regulation of research.
Congratulations!
That's correct--A PI is the indivdual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research
Keep Going
Start over?
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That's not the correct answer.
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Establishing aResearch Review Board
03
What is the process to establishing a research review board?
DECISIONS NEEDED TO ESTABLISH AN RRB
Before you can establish a tribal research review board, there are some important decisions that need to be made first.
How review board will receive continuing human subjects protection training.
Tribal leadership should formally recognize and authorize the RRB
Operations of the review board and how expenses will be handled
Who will be responisble for ensuring everything is secure and protected
Who will be responsible for seting up the review comittee
How researchers will be notified that the RRB exists
How board members are selected
Whether the tribe wil own the data
Registering an RRB
FWA & Registering an RRB
What is the connection between obtain an FWA and registering an RRB?
These are two separate processes. However, in order to obtain an FWA, an 'institution' must designate a 'registered' IRB that is designated for the review of research for that institution. An institution may either 'register' its own IRB or list another institution's registered IRB, and submit a formal IRB authorization agreement to OHRP.
FEDERALWIDE ASSURANCE (FWA)
What is Federalwide Assurance?
Why obtain an FWA?
How does FWA affect tribal laws governing research?
Does an institution applying for an FWA need to have its own IRB?
Registering an rrb
Why register an IRB?
Registration can also be a way to demonstrate that an institution's IRB operates in accordance with established federal standards.
A 'registered' IRB can be listed on an institution's Federal Wide Assurance (FWA) application.
An institution that registers its own IRB can keep the review of research "in house"
How does registering an Irb work?
IRBs have the option to apply for 'registration' with the U.S. Department of Health and Human Services (HHS}, Office of Human Research Protections (OHRP}. Upon registration:
The IRB and hosting institution, which is referred to as 'IORG' by OHRP, will be placed in an OHRP database
A registered IRB is subject to audits from OHRP
The institution and designated IRB will be assigned an IRB number and an IORG number respectively. These numbers are accessible to the public and can be listed in grant applications and grant correspondence.
What are the prerequisites for IRB registration?
Before you begin your registration process, you should have the following information at hand:
Identify number of active research protocols (or research studies 'current' or 'in process') in the past year.
Identify number of active research protocols conducted or supported by the U.S. Department of Health and Human Services (HHS).
THE CONTACT INFORMATION FOR THE FOLLOWING:
- the institution
- a top institutional or Tribal official
- designated contact person for the IRB
- IRB Chairperson
A roster of the IRB membership and each individual's role on the IRB - in accordance with federal guidelines
For other requirements, access the electronic application here: http://ohrp.cit.nih.gov/efile/Default.aspx
SECRET CLUES
Find all the secret clues to advance to the next section
start
What is ONE decision needed to establishing an RRB?
Tribal leadership should formally recognize and authorize the RRB
Rent out space for meetings
Collecting signatures from tribal members
01 / 02
Drag the magnifying glass to discover the 3 options and then choose the correct answer
What is Federalwide Assurance?
The report created In 1974 by the Department of Health Education and Welfare promulgated the regulations on the Protection of Human Subjects
A document submitted to the OHRP which is a written commitment to comply with the federal regulations for the protection of human subjects.
The document that the institution and designated IRB will be assigned an IRB number and an IORG number respectively.
A full, detailed description of the project
02/02
Drag the magnifying glass to discover the 4 options and then choose the correct answer
Congratulations, you have passed all the clues!
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Start over?
04
RRB Review Process
What goes into a research review and decision process?
ProtocolSubmitted
RESEARCHREVIEWPROCESS
RESEARCHREVIEWPROCESS
Decision Made, Updates Requested
ReviewCommences
ResearchProtocol Reviewed
RevisionsRequested
Why have the research review process?
The research review process is so the WRRB can decide if the benefits of the research have been maximized and the risks minimized to then make a final determination.
After examining the materials the researcher provides, the WRRB decides if the benefits of the research have been maximized and the risks minimized and make a final determination whether the benefits justify the risks to the subjects.
What does an rrb do after reviewing the project?
Finally, the WRRB may decide to disapprove the project and will notify the PI of its decision and if there is any level of appealing the denial.
The WRRB may request that the researcher make specific changes to the procedures and ask that the protocol be revised and resubmitted for review.
It is important for the tribal research review board to keep documents and store correspondence, such as:
In addition to reviewing new research protocols, WRRBs also review continuing projects or those that have changes in their procedures.
Continuing projects are reviewed yearly (or more often if the WRRB feels it is necessary).
Decision Made,Updates Requested
Protocol Submitted
Review Commences
Revisions Requested
Research Reviewed
+ Info
Elements of a Review
Every review requires six cyclical steps to complete.
Understand the Research
Obtain Additional Information
Ensure the Consent Process Fully Informs and Freely Consents Potential Particiapnts
Ensure Justice
Maximize Potential Benefits
Minimize Potential Harms
a full description of the proposed project
How Does the RRB Make its Decision?
materials the subjects will use (surveys, questionnaires, tests, etc.)
The review process begins when the Principal Investigator provides the WRRB with all the necessary materials (protocol) to conduct their review…
a description of the way subjects will be recruited and provide consent to participate in the project (including a consent form)
how the subjects' confidentiality will be maintained.
Tribal research review decisions
When a Tribal Research Review Board has reviewed a research protocol, they vote and the decision could be to:
1 APPROVE THE RESEARCH
The research can start and the board can request that a researcher provide updates with the time specified, for example, regular updates during a one-year period.
2 APPROVE WITH RECOMMENDATIONS
The research can start and there are items given to the investigators to make the research project more responsive to local tribal circumstances.
3 APPROVE WITH CONDITIONS
The research cannot start and there are concerns that must be addressed first. The revised research protocol is reviewed once changes have been made.
4 DEFER
The research cannot start, and a decision is not made at all because there are key elements missing. The revised research protocol is reviewed once changes have been made.
5 NOT APPROVABLE AS SUBMITTED
The research is disapproved and cannot proceed.
FILL IN THE BLANKS GAME
There are _____________ cyclical elements of a review.
six
Six
Nine
Five
Continuing projects are reviewed _____________ .(Or more often, if the WRRB feels it's necessary.)
Monthly
yearly
Yearly
Every two years
Congratulations!
Kuli-kiseht! Good Job!
TRY AGAIN?
Resources
05
What comes next?
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
ADDITIONAL RESOURCES
This interactive educational guide provides supplemental information about research review boards. The following pages include additional, in-depth resources and trainings.
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
04
03
01
02
ADDITIONAL RESOURCES
The University of Arizona Native Peoples Technical Assistance Office provides research support; training and education; and technical assistance for tribal community development
The University of Arizona Human Subjects Protection Program provides information on IRB Assurance and Registration, IRB Roster, Statements of Regulatory Adherence, and fee charges
The National Congress of American Indians has information about the foundations, ethics, and practices of research resulting in the construction of AI/AN codes, contracts, and IRBs
The Indian Health Service provides additional resources regarding IRBs, grants, research studies, and programs
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
ADDITIONAL RESOURCES
07
06
05
For further information about the Belmont Report, the Nuremberg Code, and Helsinki, please visit the “Ethical Codes & Research Standards” section of the OHRP website
PRIM&R is a leader for public responsibility in medicine and research providing educational programs and professional development opportunities that can be found
The Office for Human Research Protections issues written guidance’s, registers IRBs and FWAs, and provides information about the New Common Rule
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
COLLABORATIVERESEARCH CENTER FOR AMERICAN INDIAN HEALTH
A Collection of Ethical Standards and Resources on Human Subjects' Protections
Human Research Protections--Standards & Regulations
Glossary of Human Subjects' Protections Terms
The CRCAIH provides additional resources on ethical standards, human subjects' protections, and includes a glossary of terms. There is also additional training and resources to explore
Link
Link
Link
Info
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
Membership Requirements for IRB
Institutional Review Board
RECOMMENDED TRAININGS
This short video explains the membership requirements for IRBs to facilitate appropriate representation for adequate and meaningful review of human research protections.
This short video provides background on what an IRB is and the role it plays in protecting human research participants.
IRB Trainings
Here are some reccommended trainings to help in your RRB learning journey.
IRB Review Criteria
Quorum and Voting
This short tutorial explains the quorum requirement for IRB meetings and how members’ attendance and votes are counted.
A comprehensive perspective of the IRB review process.
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
ADDITIONAL LINKS
Here are some additional links on the following subjects:
NCAI POLICY RESEARCH CENTER
SAMPLE IRB AUTHORIZ- ATION AGREEMENT
HUMAN SUBJECTSRESOURCES
step 1
FEDERAL- WIDE ASSURANCE
Duis autem vel eum iriure dolor in hendrerit in
+info
Link
Link
Link
Link
We'lalin Woliwon Woliwoni
Wrong answer!
Meetings & Time Committment
The board meets up to three (3) hours per month.
Why obtain an FWA?
An FWA makes an institution eligible to apply for and be a direct recipient of federal funding for human subjects research. It is required for institutions that are in 'engaged'* in (non- exempt*) research involving human participants - that is conducted or supported by the U.S. Department of Health and Human Services.
Length of Term
May be appointed up to a 3-year in staggered term
Non-affiliated Members
Must not be employed by Wabanaki Public Health and Wellness; must not have a family member employed by Wabanaki Public Health and Wellness
How does FWA affect tribal laws governing research?
Having an FWA means that the Tribe agrees to comply with and enforce federal human subjects' protections regulations as a minimum. Tribes and all institutions that choose to obtain an FWA have the right to establish regulations in addition to the existing federal regulations protecting human subjects. For example, Tribes can incorporate federal human subjects' protections regulations into their own policy regarding research conducted on Tribal land.
What is Federalwide Asssurance?
A Federal Wide Assurance (FWA) is document that an institution submits to the Office of Human Research Protections (OHRP). It is a written commitment to comply with the federal regulations for the protection of human subjects. Currently the FWA is the only type of assurance accepted by OHRP.
Scientific Members
Researcher investigator or scientist by profession, able to evaluate the scientific merits of a project.
One member who is not directly affiliated with the tribe. The board members should not have conflicts of interest. For example, if the researcher is related to one of the board members, the board member should not vote.
It is important for the tribal research review board to keep documents and store correspondence, such as:
- All correspondence with researchers including copies of submitted protocols, consents, surveys, interview or focus group questions, and letters going to and from the review board.
- Written policies and procedures of the research review board.
- Meeting minutes that include who was present, time the meeting started and ended, and decisions made, including summary of discussion.
- A list of board members and a copy of their resumes.
Wrong answer!
Wrong answer!
Principal Investigator's Responsibilities
PI's responsibilities include, but are not excluded to:
- Must accept full responsibility for study
- Protecting human subject's safety, rights, and welfare
- Ensuring informed consent is appropriately obtained from each participant;
- possess the expertise, time, and commitment to conduct the research;
A PI or Co-Investigator (Co-I) is "the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research". The PI begins the research review process when they provide the WRRB with all the necessary materials to conduct their review.
Read more
Reference
Federal Wide Assurance for the Protection of Human Subjects 3(c}. Accessed July 17, 2014: www.hhs.gov/ohrp/assurances/assurances/filasurt.html#sectionb
Wrong answer!
Principal Investigator's Responsibilities
PI's responsibilities include, but are not excluded to:
- Must accept full responsibility for study
- Protecting human subject's safety, rights, and welfare
- Ensuring informed consent is appropriately obtained from each participant;
- possess the expertise, time, and commitment to conduct the research;
A PI or Co-Investigator (Co-I) is "the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research". The PI begins the research review process when they provide the WRRB with all the necessary materials to conduct their review.
Read more
Research Review Board Coordinator
Responsibilities
Role
The Research Review Board Coordinator is funded as a part of the Native American Research Center for Health (NARCH) grant. For the WRRB, the hire will be an employee of Wabanaki Public Health and Wellness (WPHW). The research review board coordinator is instrumental in the design and set-up of infrastructure for the review and regulation of research. The WRRB Coordinator is part of a team that supports the work of the WRRB.
- This position identifies and advises the RRB of potential areas of non-compliance;
- Processes RRB approvals, protocol amendments, and renewals, adverse events, and study closures;
- And provides guidance, support and training to investigators and research staff regarding procedural requirements for submission.
Institutional Officer
Role
Responsibility
Eligibility
THE BELMONT REPORT
What is the Belmont Report?
The Belmont Report was written by the National Commission for the Protection of Human Subjects and Biomedical and Behavioral Research. The Belmont Report (1979) outlines a code of conduct of ethical principles for research with human subjects. The Commission was charged with identifying the basic ethical principles of
Read more +
biomedical and behavioral research conduct that recognized the social benefit of medical research while acknowledging its dark history. The Report was published after nearly four years of monthly discussions.
Does an institution applying for an FWA need to have its own IRB?
No. An institution can list an external IRB registered with OHRP (and their IRB registration number) on its FWA application. However, both organizations must agree on this relationship, and confirm the relationship to OHRP with a written 'IRB authorization agreement' (see CRCAIH Glossary) between institutions.
Institutional Officer
Role
Responsibility
Eligibility
Data Ownership
Decisions need to be made on who will own the data. There are a few questions to ask, such as:
- If the tribe owns the data, how should the data be received (format)?
- Where and for how long will the data be stored?
- Who will have access to the data?
Need a Hint?
Let's look back...
Click on the image to enlarge
Membership
All board members must be trained in human subjects protection, at least every three years. For official decisions to be made during a meeting, there must be a quorum and at least one community member and one
It is ideal to have a person who is in charge of the board, i.e., a Chair, and someone to take minutes and to take care of all the written materials.
Unfortunately, most tribal research review committees are voluntary and do not receive any financial compensation.
It is also a right of tribal sovereignty to govern the activities, i.e., research, that occurs in tribal communities. Not every tribal community may need a research review committee however. For example, if a tribe is not going to participate in research, a research review committee may not be necessary.
Need a hint?
Let's look back...
Click the image to enlarge
Wrong answer!
Research Review Board Coordinator
Responsibilities
Role
The Research Review Board Coordinator is funded as a part of the Native American Research Center for Health (NARCH) grant. For the WRRB, the hire will be an employee of Wabanaki Public Health and Wellness (WPHW). The research review board coordinator is instrumental in the design and set-up of infrastructure for the review and regulation of research. The WRRB Coordinator is part of a team that supports the work of the WRRB.
- This position identifies and advises the RRB of potential areas of non-compliance;
- Processes RRB approvals, protocol amendments, and renewals, adverse events, and study closures;
- And provides guidance, support and training to investigators and research staff regarding procedural requirements for submission.
Expenses
Operations of RRB
Decisions on how expenses will be handled need to be determined.
Decisions on the operations of the review board should be established, for example:
- Who pays for copies, phone calls?
- Where will the meetings be held?
- Where will the documents be received and stored?
Non-Scientific Members
Expertise in non-scientific area, professional or otherwise For example: Culture
One member who is not directly affiliated with the tribe. The board members should not have conflicts of interest. For example, if the researcher is related to one of the board members, the board member should not vote.
Wabanaki Research Review Board Educational Toolkit
Jillian Worster
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Transcript
Wabanaki Research Review Board
Wabanaki Public Health and Wellness
06/10/18
Kulasihkulpon!
We welcome you!
Welcome to the Wabanaki Research Review Board Interactive Educational Toolkit!
This toolkit is designed to guide you through the details of research review boards. The toolkit is divided into five sections, feel free to explore at your own pace. Each section ends with a review in either the form of a quiz or a game.
Kisac?
This toolkit was created by Jillian Worster, Passamaquoddy Tribe
INDEX
In case you need a break, this page is an easy navigational tool to select a new section.
Wabanaki Research Review Board
Establishing a Research Review Board
WRRB Membership
AdditionalResources
RRB Review Process
01
Wabanaki Research Review Board
What are tribal research review boards?
Wabanaki Research review board (WRRB)
The Wabanaki Research Review Board (WRRB) is a committee that reviews research proposals to be conducted on Wabanaki Citizens, or within Tribal Territories or where Wabanaki citizens are the subject of data collection.
Why have a Tribal Research Review Board?
What is a Tribal Research Review Board?
A tribal research review board is a group of individuals that have interest in ensuring tribal members and the tribal community are receiving the most from a research project and are willing to volunteer time to review a lot of written materials.
It is important to have a tribal research review board to ensure tribal members and the tribal community are protected, from a tribal perspective, and have optimal benefit from a research project.
Info
+ info
BENEFITS OF A RESEARCH REVIEW BOARD
Why do we need a research review board?
Allows for greater and more consistent protections for the community
Saves time for the Tribes and the investigator, making the research review process more efficient
Facilitates dedicated time and effort to research review process, including training of board members
Creates clear guidelines and contracts for collaborations between researchers and the tribes served
Option to utilize external consultants, who are also Wabanaki citizens when field-specific expertise needed
What kind of research projects does the RRB review?
WRRB is charged with reviewing all research projects involving human subjects and will expand their scope to include research conducted within Tribal Territories, papers, and presentations about Wabanaki Citizens. In addition, they will also review any publications that include Wabanaki data.
Importance of research
Defining Research
Research is a process to answer a question, gain knowledge, or search for a solution to a problem.
Tribally Driven Decisions
Self-Determination
Research outcomes can drive decisions essential to tribal citizens. Knowing how to best gather new research data is crucial.
Tribes can exercise their right to self-determination through determing what research is done in their communities and prioritizing topics vital to tribal citizens. Research must benefit tribes and support positive change.
Where does an rrb get its authority?
RRB'S AUTHORITY
The WRRB applies to initially establish a review board as well as ongoing application for continuation.
01
In 1974, the Department of Health Education and Welfare promulgated the regulations on the Protection of Human Subjects known as the Belmont Report Review Boards are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services.
OHRP assists in their work including receiving and investigating claims of inappropriate research practices.
02
The WRRB provides administrative support for its activities including designation of an individual within the institution to oversee research and functions.
03
Info
6 FAQ'S
on IRB Fee Scheduling
Is there information on fees charged by other American Indian Tribal IRBs?
Should Tribal IRBs Charge Fees?
IRB FEE SCHEDULE
Should there be a policy for billing and and collection of IRB fees?
Should IRB charge for 'initial review', 'continuing reviews', and 'amendment review'?
Can research investigators use grant funds for IRB fees?
Should there be waivers or reductions of review fees?
can a Tribe be an
'institution' as defined
by ohrp?
Yes. Tribes are often treated as "public entities" or referred to as "tribal entities". * For those who consider a Tribe or Tribal department to be a non-U.S. institution, the OHRP guidelines regarding non-U.S. institutions are as follows: "Whenever non-U.S. institutions are engaged in non-exempt HHS-supported or conducted human subjects research, the regulations apply."**
How does an rrb protect special populations?
The Code of Federal Regulations requires that WRRBs give special consideration to some classes of subjects: children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons. In many cases, the WRRB may approve of research with these subjects only when it involves minimal risk or when the benefits apply to the subject directly.
Info
Who has access to rrb records?
The institution and the WRRB maintain records of WRRB activities including copies of the research protocols reviewed, minutes from meetings and correspondence. Records of the work conducted during a review are not available to the public. All records must be made available for review by OHRP.
Questions to Ask When Considering an RRB
Are researchers coming to our tribal community to introduce research projects?
What type of research is being proposed? For example, surveys, interviews, screenings, etc?
Who is being involved within the community? Existing programs, community at large?
Who should serve on the review committee?
How do we support the review committee?
Research Review Board
Institutional Review Board
s.
Research Review Board
Institutional Review Board
s.
University Research Review Boards are called...?
Research Review Board✔
Institutional Review Board✔
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University Research Review Boards are called INSTITUTIONAL REVIEW BOARDS (IRBs)
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WRRB MEMBERSHIP
What are the requirements and qualifications of WRRB membership?
Members must have the professional experience to provide appropriate scientific and ethical review.
Consists of eleven (11) voting members of varying backgrounds.
Membership
The WRRB strives for appropriate representation in gender, racial and cultural heritage.
There must be at least one member who is not otherwise affiliated with the institution (a community representative).
At least one member must be a member of the scientific community and at least one member whose primary concerns are nonscientific.
RESPONSIBILITIES OF WRRB MEMBERS
Attend meetings regularly to ensure quorum.
Complete training on human subjects’ protections regulations and research review processes.
Actively Participate in WRRB meetings and offer expertise for the ethical review and monitoring of research.
Review research protocols and documents prior to the scheduled meeting.
RESPONSIBILITIES OF WRRB MEMBERS
Notify their alternate if they are unable to attend a scheduled meeting
Inform coordinator in the event of a conflict of interest for a research protocol.
Maintain strict confidentiality regarding research protocols and IRB proceedings.
Members
There are some key members to an RRB with specific roles
Principal Investigator (PI)
Institutional Officer (IO)
Research Review Board Coordinator
Members
There are some key members to an RRB with specific roles
Principal Investigator (PI)
Institutional Officer (IO)
Research Review Board Coordinator
Qualifications
There are certain qualifications for WRRB members to be mindful of...
Duration Length of Term
Non-Scientific Members
Meetings and Time Committment
Scientific Members
Non-affiliated Members
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What is a Principal Investigator?
the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research
Is the individual legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance.
The individual who's role is instrumental in the design and set-up of infrastructure for the review and regulation of research.
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That's correct--A PI is the indivdual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research
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Establishing aResearch Review Board
03
What is the process to establishing a research review board?
DECISIONS NEEDED TO ESTABLISH AN RRB
Before you can establish a tribal research review board, there are some important decisions that need to be made first.
How review board will receive continuing human subjects protection training.
Tribal leadership should formally recognize and authorize the RRB
Operations of the review board and how expenses will be handled
Who will be responisble for ensuring everything is secure and protected
Who will be responsible for seting up the review comittee
How researchers will be notified that the RRB exists
How board members are selected
Whether the tribe wil own the data
Registering an RRB
FWA & Registering an RRB
What is the connection between obtain an FWA and registering an RRB?
These are two separate processes. However, in order to obtain an FWA, an 'institution' must designate a 'registered' IRB that is designated for the review of research for that institution. An institution may either 'register' its own IRB or list another institution's registered IRB, and submit a formal IRB authorization agreement to OHRP.
FEDERALWIDE ASSURANCE (FWA)
What is Federalwide Assurance?
Why obtain an FWA?
How does FWA affect tribal laws governing research?
Does an institution applying for an FWA need to have its own IRB?
Registering an rrb
Why register an IRB?
Registration can also be a way to demonstrate that an institution's IRB operates in accordance with established federal standards.
A 'registered' IRB can be listed on an institution's Federal Wide Assurance (FWA) application.
An institution that registers its own IRB can keep the review of research "in house"
How does registering an Irb work?
IRBs have the option to apply for 'registration' with the U.S. Department of Health and Human Services (HHS}, Office of Human Research Protections (OHRP}. Upon registration:
The IRB and hosting institution, which is referred to as 'IORG' by OHRP, will be placed in an OHRP database
A registered IRB is subject to audits from OHRP
The institution and designated IRB will be assigned an IRB number and an IORG number respectively. These numbers are accessible to the public and can be listed in grant applications and grant correspondence.
What are the prerequisites for IRB registration?
Before you begin your registration process, you should have the following information at hand:
Identify number of active research protocols (or research studies 'current' or 'in process') in the past year.
Identify number of active research protocols conducted or supported by the U.S. Department of Health and Human Services (HHS).
THE CONTACT INFORMATION FOR THE FOLLOWING:
A roster of the IRB membership and each individual's role on the IRB - in accordance with federal guidelines
For other requirements, access the electronic application here: http://ohrp.cit.nih.gov/efile/Default.aspx
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What is ONE decision needed to establishing an RRB?
Tribal leadership should formally recognize and authorize the RRB
Rent out space for meetings
Collecting signatures from tribal members
01 / 02
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What is Federalwide Assurance?
The report created In 1974 by the Department of Health Education and Welfare promulgated the regulations on the Protection of Human Subjects
A document submitted to the OHRP which is a written commitment to comply with the federal regulations for the protection of human subjects.
The document that the institution and designated IRB will be assigned an IRB number and an IORG number respectively.
A full, detailed description of the project
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RRB Review Process
What goes into a research review and decision process?
ProtocolSubmitted
RESEARCHREVIEWPROCESS
RESEARCHREVIEWPROCESS
Decision Made, Updates Requested
ReviewCommences
ResearchProtocol Reviewed
RevisionsRequested
Why have the research review process?
The research review process is so the WRRB can decide if the benefits of the research have been maximized and the risks minimized to then make a final determination.
After examining the materials the researcher provides, the WRRB decides if the benefits of the research have been maximized and the risks minimized and make a final determination whether the benefits justify the risks to the subjects.
What does an rrb do after reviewing the project?
Finally, the WRRB may decide to disapprove the project and will notify the PI of its decision and if there is any level of appealing the denial.
The WRRB may request that the researcher make specific changes to the procedures and ask that the protocol be revised and resubmitted for review.
It is important for the tribal research review board to keep documents and store correspondence, such as:
In addition to reviewing new research protocols, WRRBs also review continuing projects or those that have changes in their procedures.
Continuing projects are reviewed yearly (or more often if the WRRB feels it is necessary).
Decision Made,Updates Requested
Protocol Submitted
Review Commences
Revisions Requested
Research Reviewed
+ Info
Elements of a Review
Every review requires six cyclical steps to complete.
Understand the Research
Obtain Additional Information
Ensure the Consent Process Fully Informs and Freely Consents Potential Particiapnts
Ensure Justice
Maximize Potential Benefits
Minimize Potential Harms
a full description of the proposed project
How Does the RRB Make its Decision?
materials the subjects will use (surveys, questionnaires, tests, etc.)
The review process begins when the Principal Investigator provides the WRRB with all the necessary materials (protocol) to conduct their review…
a description of the way subjects will be recruited and provide consent to participate in the project (including a consent form)
how the subjects' confidentiality will be maintained.
Tribal research review decisions
When a Tribal Research Review Board has reviewed a research protocol, they vote and the decision could be to:
1 APPROVE THE RESEARCH
The research can start and the board can request that a researcher provide updates with the time specified, for example, regular updates during a one-year period.
2 APPROVE WITH RECOMMENDATIONS
The research can start and there are items given to the investigators to make the research project more responsive to local tribal circumstances.
3 APPROVE WITH CONDITIONS
The research cannot start and there are concerns that must be addressed first. The revised research protocol is reviewed once changes have been made.
4 DEFER
The research cannot start, and a decision is not made at all because there are key elements missing. The revised research protocol is reviewed once changes have been made.
5 NOT APPROVABLE AS SUBMITTED
The research is disapproved and cannot proceed.
FILL IN THE BLANKS GAME
There are _____________ cyclical elements of a review.
six
Six
Nine
Five
Continuing projects are reviewed _____________ .(Or more often, if the WRRB feels it's necessary.)
Monthly
yearly
Yearly
Every two years
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Kuli-kiseht! Good Job!
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Resources
05
What comes next?
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
ADDITIONAL RESOURCES
This interactive educational guide provides supplemental information about research review boards. The following pages include additional, in-depth resources and trainings.
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
04
03
01
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ADDITIONAL RESOURCES
The University of Arizona Native Peoples Technical Assistance Office provides research support; training and education; and technical assistance for tribal community development
The University of Arizona Human Subjects Protection Program provides information on IRB Assurance and Registration, IRB Roster, Statements of Regulatory Adherence, and fee charges
The National Congress of American Indians has information about the foundations, ethics, and practices of research resulting in the construction of AI/AN codes, contracts, and IRBs
The Indian Health Service provides additional resources regarding IRBs, grants, research studies, and programs
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
ADDITIONAL RESOURCES
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06
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For further information about the Belmont Report, the Nuremberg Code, and Helsinki, please visit the “Ethical Codes & Research Standards” section of the OHRP website
PRIM&R is a leader for public responsibility in medicine and research providing educational programs and professional development opportunities that can be found
The Office for Human Research Protections issues written guidance’s, registers IRBs and FWAs, and provides information about the New Common Rule
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
COLLABORATIVERESEARCH CENTER FOR AMERICAN INDIAN HEALTH
A Collection of Ethical Standards and Resources on Human Subjects' Protections
Human Research Protections--Standards & Regulations
Glossary of Human Subjects' Protections Terms
The CRCAIH provides additional resources on ethical standards, human subjects' protections, and includes a glossary of terms. There is also additional training and resources to explore
Link
Link
Link
Info
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
Membership Requirements for IRB
Institutional Review Board
RECOMMENDED TRAININGS
This short video explains the membership requirements for IRBs to facilitate appropriate representation for adequate and meaningful review of human research protections.
This short video provides background on what an IRB is and the role it plays in protecting human research participants.
IRB Trainings
Here are some reccommended trainings to help in your RRB learning journey.
IRB Review Criteria
Quorum and Voting
This short tutorial explains the quorum requirement for IRB meetings and how members’ attendance and votes are counted.
A comprehensive perspective of the IRB review process.
RESOURCES
INTRO
RESOURCES
CRCAIH
TRAININGS
LINKS
ADDITIONAL LINKS
Here are some additional links on the following subjects:
NCAI POLICY RESEARCH CENTER
SAMPLE IRB AUTHORIZ- ATION AGREEMENT
HUMAN SUBJECTSRESOURCES
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FEDERAL- WIDE ASSURANCE
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+info
Link
Link
Link
Link
We'lalin Woliwon Woliwoni
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Meetings & Time Committment
The board meets up to three (3) hours per month.
Why obtain an FWA?
An FWA makes an institution eligible to apply for and be a direct recipient of federal funding for human subjects research. It is required for institutions that are in 'engaged'* in (non- exempt*) research involving human participants - that is conducted or supported by the U.S. Department of Health and Human Services.
Length of Term
May be appointed up to a 3-year in staggered term
Non-affiliated Members
Must not be employed by Wabanaki Public Health and Wellness; must not have a family member employed by Wabanaki Public Health and Wellness
How does FWA affect tribal laws governing research?
Having an FWA means that the Tribe agrees to comply with and enforce federal human subjects' protections regulations as a minimum. Tribes and all institutions that choose to obtain an FWA have the right to establish regulations in addition to the existing federal regulations protecting human subjects. For example, Tribes can incorporate federal human subjects' protections regulations into their own policy regarding research conducted on Tribal land.
What is Federalwide Asssurance?
A Federal Wide Assurance (FWA) is document that an institution submits to the Office of Human Research Protections (OHRP). It is a written commitment to comply with the federal regulations for the protection of human subjects. Currently the FWA is the only type of assurance accepted by OHRP.
Scientific Members
Researcher investigator or scientist by profession, able to evaluate the scientific merits of a project.
One member who is not directly affiliated with the tribe. The board members should not have conflicts of interest. For example, if the researcher is related to one of the board members, the board member should not vote.
It is important for the tribal research review board to keep documents and store correspondence, such as:
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Principal Investigator's Responsibilities
PI's responsibilities include, but are not excluded to:
A PI or Co-Investigator (Co-I) is "the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research". The PI begins the research review process when they provide the WRRB with all the necessary materials to conduct their review.
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Reference
Federal Wide Assurance for the Protection of Human Subjects 3(c}. Accessed July 17, 2014: www.hhs.gov/ohrp/assurances/assurances/filasurt.html#sectionb
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Principal Investigator's Responsibilities
PI's responsibilities include, but are not excluded to:
A PI or Co-Investigator (Co-I) is "the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research". The PI begins the research review process when they provide the WRRB with all the necessary materials to conduct their review.
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Research Review Board Coordinator
Responsibilities
Role
The Research Review Board Coordinator is funded as a part of the Native American Research Center for Health (NARCH) grant. For the WRRB, the hire will be an employee of Wabanaki Public Health and Wellness (WPHW). The research review board coordinator is instrumental in the design and set-up of infrastructure for the review and regulation of research. The WRRB Coordinator is part of a team that supports the work of the WRRB.
Institutional Officer
Role
Responsibility
Eligibility
THE BELMONT REPORT
What is the Belmont Report?
The Belmont Report was written by the National Commission for the Protection of Human Subjects and Biomedical and Behavioral Research. The Belmont Report (1979) outlines a code of conduct of ethical principles for research with human subjects. The Commission was charged with identifying the basic ethical principles of
Read more +
biomedical and behavioral research conduct that recognized the social benefit of medical research while acknowledging its dark history. The Report was published after nearly four years of monthly discussions.
Does an institution applying for an FWA need to have its own IRB?
No. An institution can list an external IRB registered with OHRP (and their IRB registration number) on its FWA application. However, both organizations must agree on this relationship, and confirm the relationship to OHRP with a written 'IRB authorization agreement' (see CRCAIH Glossary) between institutions.
Institutional Officer
Role
Responsibility
Eligibility
Data Ownership
Decisions need to be made on who will own the data. There are a few questions to ask, such as:
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Membership
All board members must be trained in human subjects protection, at least every three years. For official decisions to be made during a meeting, there must be a quorum and at least one community member and one
It is ideal to have a person who is in charge of the board, i.e., a Chair, and someone to take minutes and to take care of all the written materials.
Unfortunately, most tribal research review committees are voluntary and do not receive any financial compensation.
It is also a right of tribal sovereignty to govern the activities, i.e., research, that occurs in tribal communities. Not every tribal community may need a research review committee however. For example, if a tribe is not going to participate in research, a research review committee may not be necessary.
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Research Review Board Coordinator
Responsibilities
Role
The Research Review Board Coordinator is funded as a part of the Native American Research Center for Health (NARCH) grant. For the WRRB, the hire will be an employee of Wabanaki Public Health and Wellness (WPHW). The research review board coordinator is instrumental in the design and set-up of infrastructure for the review and regulation of research. The WRRB Coordinator is part of a team that supports the work of the WRRB.
Expenses
Operations of RRB
Decisions on how expenses will be handled need to be determined.
Decisions on the operations of the review board should be established, for example:
Non-Scientific Members
Expertise in non-scientific area, professional or otherwise For example: Culture
One member who is not directly affiliated with the tribe. The board members should not have conflicts of interest. For example, if the researcher is related to one of the board members, the board member should not vote.