IRB members represent a diverse set of perspectives and expertise appropriate to the many kinds of research conducted at Duke. Our IRB members are physicians, researchers, clinicians, nurses, pharmacists, physical therapists (among other members of the medical community), engineers, lawyers, non-scientists and community members all contributing their knowledge, viewpoints, and hard work.
All DUHS IRB members are required to complete the following training:
- Complete the required ethics credentialing (CITI modules) that Duke Health researchers must take as well
- Observe two IRB meetings
- Meet in person or virtually for an hour's orientation session, before your first & second IRB meetings
These steps must be completed before you can be granted access to iRIS as an IRB member.
Navigate to Training & Resources for instructions on the required ethics credentialing (CITI modules).
- It is your responsibility as an IRB Member to attend the monthly meeting of the IRB to which you are assigned. If you are unable to attend, then you must arrange for a substitute (another IRB Member from your Department) to attend the meeting in your place, and let the Board Specialist know immediately.
- Each IRB meeting agenda has approximately 20 – 24 items for review. You are expected to be familiar with each study submission in iRIS before the meeting. At a minimum, please review each study’s research summary, consent form(s), and advertisements before you come to an IRB meeting. After you have attended your first two IRB meetings, you will be assigned 1-2 protocols to present as a Primary Reviewer at the 3rd meeting you attend.
- There are checklists for Primary Reviewers to use to prepare their reviews and fill out in iRIS. At the meeting, you will make a brief summary presentation of your assigned submission along with your recommendations for any changes you feel are needed to satisfy the requirements of 45 CFR 46.111 or 21 CFR 56.111. As a Primary Reviewer, you are required to complete your Primary Reviewer Checklist in iRIS prior to the start of the IRB meeting.
- You will find it helpful as a Primary Reviewer to communicate with the PI and the study team before the meeting to resolve any questions or concerns. You may also contact the Chair, Vice Chair, or IRB Specialist with any issues.
- If you have email communication with the PI and study team prior to the IRB meeting, you must upload that communication into iRIS. Talk with your IRB Specialist if you need assistance.
- You may also be asked to serve as the additional expertise for various protocols on the meeting agenda that are in your area of expertise. If that is the case, this will be noted on the agenda sent to all attending members several days before the meeting. The Federal Regulations state that the IRB must have the appropriate expertise at the meeting to review the studies on the agenda. Your role is to bring to the IRB any concerns you have about the study based on your expertise and experience in the area, and you may be asked to provide your perspective should questions arise during discussion about the risk of study elements or about the disease or condition being studied.
- When you receive a draft copy of the minutes of the IRB meeting you attended, please review the minutes for accuracy and completeness, and send your edits and comments to the IRB writer.
- You will be required to sign a Confidentiality Agreement when you become an IRB member. The materials presented and all discussions at an IRB meeting are considered confidential. What happens in an IRB meeting stays in an IRB meeting!
DUHS IRB Members are responsible for making known any potential or perceived conflict of interest (COI) concerning protocols reviewed by the IRB. If you hold any of the following roles or relationships to a study undergoing IRB review, then you are considered to have a potential or perceived conflict:
- Principal Investigator
- Co-Principal Investigator or other key personnel
- Investigator receiving funding from the study, as listed in the study budget
- In a supervisory role over the PI of the study,
- Involved in research utilizing a competing technology such that the ability to render an objective assessment is compromised; or
- Family member of PI (spouse or child) or otherwise involved in a close personal relationship with a member of the study team.
- You have a relationship, financial or otherwise, with the sponsor of the study.
You are also considered to have a conflict when you or a member of your immediate family has any of the following:
- Involvement in the design, conduct, or reporting of the research with the following exception:
- An IRB member who is listed on an IRB protocol as a member of the study’s Key Personnel but whose study activities are limited to (i) the performance of commercial services for the investigator (or performing other genuinely non-collaborative services meriting neither professional recognition nor publication privileges), while (ii) adhering to commonly recognized professional standards for maintaining privacy and confidentiality, is not considered to have a conflicting interest on this basis.
- Ownership interest, stock options, or other financial interest related to the research unless it meets four tests:
- The value of the interest does not exceed $5,000 when aggregated for the immediate family.
- The interest is publicly traded on a stock exchange.
- The value of the interest does not exceed 5% interest in any one single entity when aggregated for the immediate family.
- No arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research.
- Compensation related to the research unless it meets two tests:
- The value of the compensation does not exceed $5,000 in the past year when aggregated for the immediate family.
- No arrangement has been entered into where the amount of compensation will be affected by the outcome of the research.
- Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.
- Board or executive relationship related to the research, regardless of compensation.
- Any other reason for which you believe that you cannot provide an independent review.
What To Do If You Think You Have a Conflict
- If you are assigned a protocol to review and you have a potential conflict with the protocol, tell your Board Specialist immediately. As you are reviewing the agenda before the meeting, please tell your Board Specialist if you have a conflict with an item on the agenda, so the conflict can be noted on the agenda and the Board Specialist will know ahead of time that you will need to leave the room during the deliberation and vote on that item.
- At the start of an IRB meeting, and prior to the beginning of the Board’s discussion of the protocol under review, if you realize then that you have a conflict, please identify any conflicting interests relating to any protocol on that day’s agenda. You may remain in the room for the general discussion of the protocol, but must leave the meeting room before the Board’s deliberation and vote. Your absence from the room will be recorded in the minutes of the meeting.
- Communicate with your IRB Chair prior to the IRB meeting if you find that a protocol has significant problems that could cause the protocol to be deferred at the IRB meeting.
- Communicate with the PI and study team prior to the IRB meeting to answer questions you have about the study, clarify issues, ask about study enrollment and progress, or ask for documentation you may be missing.
- Complete your review in iRIS by 1:00 PM on the day of the IRB meeting.
- If you find you cannot attend a meeting, please find a replacement from your Department (another IRB Member) to attend the meeting in your place. Notify the IRB Board Specialist for your meeting immediately, so protocol assignments can be sent to another reviewer. NOTE: If no one from your department attends the IRB meeting, then all protocols from your department may have to be pulled from the agenda. Federal Regulations require the appropriate expertise present at the meeting in order to review the items on the agenda.
- Lunch (if applicable): Please tell your Board Specialist if you have special dietary needs.
- The Board Specialist maintains quorum in the room and records the vote count for each vote. If you have to leave an IRB meeting temporarily to respond to a page, make a phone call, or visit the restroom, please notify the Board Specialist so she/he knows you are leaving.
- Tell your Board Specialist if you have to leave an IRB meeting early, or if you have to arrive late.
- If you can’t find something in iRIS, or need help navigating through iRIS, call your Board Specialist.
- When you receive a draft copy of the minutes of the IRB meeting you attended, please review the minutes for accuracy and completeness, and send your edits and comments to the IRB writer.
An abstention is neither a ‘yes’ nor a ‘no’ vote and is cast when a member is not comfortable in voting either way. Any member is free to abstain at any time. An abstention counts toward quorum but does not count toward a super majority.
A minor, unless emancipated, cannot consent to participate in research but may ‘assent’ to participation. A child 6-11 yrs. of age may give verbal assent. A child 12-18 yrs. of age may give written assent. If a child refuses to give assent after parental consent, the IRB may overrule the child’s objections when the study holds the possibility of direct benefit, the benefit is important to the health and well-being of the minor, and there is no way to obtain the potential benefit other than through participation in the study. Failure of a minor to object to study participation cannot be construed as assent.
Business Item (also known as an Amendment)
A business item (BI), or amendment, is a revision to a previously approved study. A BI may involve a protocol change, consent form change, or addition of other new or revised study documents.
Conflict of Interest (COI) Management Plan
Management plans are issued by Duke’s COI committee and describe the limits of a researcher’s ability to serve as PI or a member of a study team. Management plans define a relationship between a researcher and a company. The management plan also describes the disclosures required in consent forms and publications that result from the study. One researcher may have multiple management plans.
Continuing Review (or Renewal)
Any annual (or otherwise) review of a study, after the initial review, can be referred to as a renewal or continuing review (CR). FDA regulations require that studies be reviewed at intervals of no greater than 1 year until study closure. While an IRB can review a study more frequently than annually, it cannot review a study at intervals greater than 1 year, if the study is greater than minimal risk, or if the study is FDA regulated.
The Clinical Research Unit (CRU) is the departmental unit to which a PI belongs. The CRU is responsible for the initial scientific, feasibility, financial, and IT reviews of a new study prior to its arrival in the IRB.
Office of Audit, Risk and Compliance
The Office of Audit, Risk and Compliance (OARC) is an arm of the School of Medicine’s Compliance Office. The DUHS IRB does not conduct audits of research studies; however, it can request that OARC conduct the audit and issue a report to the IRB. When an OARC audit report is presented to a convened IRB, OARC auditors frequently attend to answer the IRB members’ questions.
Submissions to the IRB that: (1) require substantial revisions (e.g., specific wording cannot be provided by the convened IRB); or (2) prompt questions that cannot be answered within the context of the IRB meeting, will be deferred for further review by the convened IRB at a later date.
The Duke Office of Clinical Research (DOCR) is a department within the School of Medicine that provides support to researchers in the form of education and training, IT and REDCAP support, help with IRB submissions, and help with the billing and financial aspects of a study.
An emancipated minor is an individual under the age of 18 yrs. who has the rights and privileges of an adult, including the right to consent to participate in a research study. In North Carolina, a minor may become emancipated in 1 of 2 ways: (i) marriage; or (ii) court order. Childbirth does not result in emancipation for a minor parent.
Submissions to the IRB (initial reviews, continuing reviews, amendments, safety events) that meet the federal definition of ‘minimal risk’ can be reviewed in the IRB office by a Chair or designee. The convened IRB is informed of these reviews via a report each month at a convened meeting. Expedited reviews constitute approximately two-thirds of the DUHS IRB’s total workload.
Along with the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA) is the other regulatory body with oversight authority over research with human subjects. FDA oversight extends to all research with human subjects involving investigational drugs, devices and biologics, regardless of funding source. Like OHRP, the FDA is a division of the U.S. Department of Health and Human Services (DHHS), and FDA auditors can inspect the Duke IRB’s records involving FDA-regulated studies at any time.
Full Board Review
Submissions to the IRB (initial reviews, continuing reviews, amendments, safety events) that do not meet the federal definition of ‘minimal risk’ must be reviewed by a convened IRB.
A Federal Wide Assurance (FWA) is a document on file with OHRP/FDA. It states that an institution conducting research with human subjects will conduct that research in accordance with applicable federal regulations. An FWA is required for any institution that accepts federal funding. The Duke University Health System’s FWA number is 00009025.
The Human Research Protection Program (HRPP) is the total of all departments and individuals responsible for the protection of human research subjects. At Duke, the HRPP consists not only of the IRB, but also the CRUs, ORC, DOCR, OARC, and the entire research community. The HRPP is headed by the Institutional Official (IO).
An IRB Authorization Agreement (IAA) is a written document between Duke and an external site or individual. It allows the DUHS IRB to extend its IRB oversight to the site/individual for the conduct of a specific study.
An Investigational Device Exemption (IDE) is a status granted by the FDA to a device that has not been granted approval by the FDA for marketing in the U.S. An IDE allows the investigational device to be transported across state lines and used in humans for specified research purposes.
An Investigational New Drug (IND) is a status granted by the FDA for a drug, combination of drugs, or a biologic that is not yet approved by the FDA for marketing. An IND allows the investigational drug, drug combination, or biologic to be transported across state lines and used in humans for specified research purposes.
The Institutional Official (IO) for an institution is an individual who is held responsible by OHRP and the FDA for the institution’s entire HRPP. This individual is named on the institution’s FWA. Duke Health's IO is Dean Mary Klotman, MD.
Key Personnel are the individuals who have access to Protected Health Information (PHI) and generate data either through direct interactions with subjects or through access to their medical records. Key Personnel and their study roles must be listed on an IRB submission.
A Legally Authorized Representative (LAR) is an adult who is able to make decisions concerning study participation for another adult who has been determined to be incapable of making those decisions independently. Utilization of an LAR must be specifically approved by the IRB.
Rosters for all IRB committees (boards) must be on file and current with OHRP/FDA. A typical roster contains a listing of the Chair, Vice Chair, Primary Members and Alternate Members. Each member will be listed by name, degree(s), Duke affiliation, and area(s) of expertise. IRB rosters at Duke are updated each month with OHRP/FDA and can be found on the IRB website.
A study is considered ‘minimal risk’ if the probability and magnitude of harm anticipated in the research is no greater than the risk encountered in daily life, including routine physical exams. For the exact definition, see 45 CFR 46.102. IRB submissions (initial reviews, CRs, amendments, safety events) that meet this definition are eligible for the expedited review process.
A minor is defined under NC state law as an individual under the age of 18 yrs. A minor cannot consent to a research study unless emancipated under NC state law. See “Assent” and “Emancipated Minor” for further explanations.
The Office of Research Contracts (ORC) is the group responsible for review of contracts with study sponsors. ORC compares the study-related injury language in a consent form to the same language in the legal contract with the sponsor to ensure consistency. They also authorize data use agreements and material transfer agreements. A member of ORC sometimes attends IRB meetings as a non-voting member.
The Office for Human Research Protections (OHRP) is the federal agency that is responsible for oversight of all federally-funded research involving human subjects. Duke applies OHRP’s regulations to all research involving human subjects, regardless of funding source. OHRP is a division of the U.S. Department of Health and Human Services. OHRP auditors may inspect the Duke IRB’s records pertaining to the review of federally-funded research studies at any time.
Pediatric Risk Assessment
All initial submissions for studies that include pediatric populations must receive a pediatric risk assessment. This assessment will include a risk level determination as described below:
- Level 1: minimal risk
- Level 2: greater than minimal risk with the possibility of direct benefit
- Level 3: greater than minimal risk with no possibility of direct benefit
- Level 4: not otherwise approvable but could provide important information about a health problem affecting minors
During its review of a study utilizing pediatric populations, the IRB must complete a pediatric risk assessment. At the time of the vote, the IRB will determine whether 1 parental signature is sufficient (permissible for levels 1 & 2) or 2 parental signatures are required (levels 3 and 4).
The Principal Investigator (PI) is the researcher who is responsible for all aspects of the conduct of a study.
Protected Health Information (PHI) is the combination of private medical information plus information that would permit, with reasonable effort, identification of an individual.
A quorum is a defined majority of attendees which must be attained in order for a convened IRB to proceed. At Duke, a quorum consists of one integer over 50% of a primary member roster. For example, if a primary member roster for an IRB contains 17 members, a quorum of 9 members must be in attendance for the meeting to proceed. At least one of those members must be a Non-Scientist.
Research with Human Subjects
Research with human subjects is a systematic investigation using data or samples derived from identifiable living humans that is designed to contribute to generalizable knowledge. Research with human subjects requires IRB review and approval.
A Review Preparatory to Research (RPR) is a notice from the study team to the IRB that the team will review, but not record, private health information (PHI) of potential subjects prior to consent. Like the waiver, it is commonly used to identify potential subjects.
Clinical research studies can be classified in four distinct phases:
|Phase #||Main Objectives||Population Studied|
|Phase I||Safety: safety, toxicity, metabolism||healthy volunteers (usually)|
|Phase II||Dosage: optimal dosing||patients|
|Phase III||Efficacy: effectiveness, safety||patients|
|Phase IV||Post-market: long term safety||patients|
In addition, a pilot study is a small scale feasibility study. Its results will be used to design the larger phase I study.
For a protocol to be approved via a convened IRB at Duke, a super majority of 75% must be achieved. For example, if 12 members vote either ‘yes’ or ‘no’ (abstentions do not count), 9 members must vote ‘yes’ for the study to be approved at Duke.
An Unanticipated Problem Involving Risk to Subjects or Others (UPIRTSO) is an event that has the possibility of increased harm to subjects or others. A UPIRTSO can be thought of as a previously unexpected “new risk”. UPIRTSOs can be adverse events, protocol deviations/violations, or noncompliance issues. A UPIRTSO may be determined by a convened IRB, or by an IRB Chair or designee via the expedited review process, depending on the risk level of the event.
A waiver or alteration of consent and/or HIPAA authorization is a document approved by the IRB that allows an investigator to forego certain requirements for obtaining consent or HIPAA authorization. It is commonly used to ascertain (identify) potential research subjects by reviewing their private health information prior to their consent.