What is an institutional review board (IRB)?
The US Code of Federal Regulations addresses the protection of human subjects participating in clinical research and outlines the role of an institutional review board (IRB). An IRB reviews research studies to assess safety, privacy and confidentiality concerns as they relate to the research that is being considered. The IRB also determines what information should be provided to the potential research participant and approves the informed consent form that is to be used before the study is started. The IRB can approve or modify studies to ensure that they include proper protections or disapprove any study that poses excess risk to a research participant. The main purpose of the IRB is to protect the rights and welfare of research participants who participate in research studies.
Who serves on an IRB?
According to the regulations, an IRB should have at least five members with varying backgrounds to ensure a sufficient review of the research studies. The IRB members are qualified based on their experience and expertise and the IRB should be diverse in terms of race, gender and cultural backgrounds. The IRB should also have at least one member who has scientific expertise and at least one member who does not have a scientific background.
What does an IRB review?
The IRB reviews research studies involving human subjects to ensure that the risks are appropriate in relation to the benefits and that there are safeguards in place to address risks encountered in the research. The regulations require an IRB to specifically review various aspects of a research study such as the study design, risk vs. benefit, the informed consent form and process, privacy protection and confidentiality.
How often does your IRB meet?
Our IRB meets daily (Monday through Friday).
What type of research and therapeutic areas can your IRB review?
Our IRB oversight has included all major therapeutic areas and all phases of clinical research, including Phase I-IV IND studies, IDE studies, NIH/federally funded research, social science and behavioral studies, registry studies, retrospective chart reviews and investigator-initiated studies.
What state/provincial laws should sponsors, CROs and clinical investigators be familiar with that relate to the conduct of clinical trials?
Sponsors, CROs and clinical investigators should be familiar with state/provincial laws where the research will be conducted, including:
- Age of adult consent/children’s assent
- Capacity to consent/legally authorized representatives
- HIV/STD reporting requirements
- Confidentiality of medical records
- Informed consent
- Clinical research
- Genetic research
- Referral fees and participant payment
- Recruitment methods
- Institutional review boards
- Investigational drugs
- Vulnerable subjects
- Medical practice and delegation of authority to perform procedures
What items can an IRB review by expedited review?
Per regulations, Advarra’s IRB can provide expedited review for:
- Research that presents no more than minimal risk. These categories are listed in OHRP Guidance; and
- “Minor changes” to previously approved research during the period (one year or less) for which approval is granted.
Advarra reviews most new research site submissions, recruitment and study-related materials, as well as some amendments and new study submissions using expedited review.
If an IRB disapproves a study, can the sponsor/CRO or principal investigator submit the study to a second IRB?
Yes. However, the FDA states that the sponsor/CRO or investigator should inform the second IRB that another IRB previously disapproved the study.
What is the review timeline for submission of a new protocol?
Once your submission is complete, IRB review will occur within 4 business days. You will receive the IRB’s determination within 1-2 business days following the review.
What is the review timeline for submission of an additional investigator for a previously approved protocol?
An investigator’s submission is reviewed within 24 hours upon receipt of a complete submission. You can expect the outcome of the review within 1-2 days after that.
What information should an independent, central IRB obtain about a research site?
Information includes the education and training of study personnel, the site’s history and experience in conducting clinical research, federal agency inspection reports, type of demographics the site will encounter, and safeguards for vulnerable subjects. In certain situations, the IRB may request that a site visit be conducted.
Does Advarra require qualifications of sub-investigators and personnel involved in the informed consent process plus the respective 1572 (if applicable) to be submitted?
No. Advarra only requires information on the principal investigator of the study and does not need the 1572 document (if applicable).
What documents are needed for initial site submissions?
A site application needs to be completed through the Advarra CIRBI Platform at CIRBI.net. In the application, there will be areas where you can upload attachments, including the CV of the principal investigator and any FDA findings within the past 5 years that are required as part of the submission. There are other places where you can upload SOPs, site-specific informed consent form language and any other supporting document that may aid in the IRB’s review.
Must each research site submit an ICF?
Additional research sites conducting a protocol previously reviewed by the board are not required to submit a copy of the ICF. However, sites with institution-specific language are invited to provide their required text to Advarra with their site submission so that text can be appropriately incorporated into the ICF. Advarra will provide each approved research site with a site-specific ICF.
What could slow the approval process for my study or site?
- Incomplete Submission Documents: Please refer to the submission form to ensure you are submitting all required documents for the review of new studies and additional sites.
- Study Placed Missing Key Information: The IRB may identify areas of concern with the protocol and defer approval of a study or require modifications as part of the approval.
- Delays in Finalization of ICF: After formal board review, additional Advarra-internal or sponsor/CRO/institution review of the ICF may be required prior to finalization. Approval documents will not be sent to sites until the ICF is finalized.
- IRB Concerns with Site Submission Information: Upon review of additional sites conducting a previously approved protocol, the IRB may note an area of concern with the site’s responses on the submission documents. If concerns are noted or the compensation for participation information is unclear, an Advarra representative will contact the site. The site must provide satisfactory resolution of the identified issues before the approval process can be completed.
- Site-Specific ICF Revisions: If a site submits a request for additional site-specific revisions, an IRB member must review the requested revisions to determine their appropriateness. In some instances, approval from the sponsor/CRO may also be required.
What are the costs associated with IRB review?
Please request a fee schedule on the Contact Us page.
How are investigators, CROs and sponsors informed of approvals or requests by the IRB?
Any time approval information is posted or there are additional requests from the IRB, you will be prompted by email notifications sent from the Advarra CIRBI Platform.
Will the IRB provide hard copies of documents?
No. All IRB documentation is electronically available through the Advarra CIRBI Platform at CIRBI.net.
How do I submit information to Advarra?
Advarra is a paperless IRB. All submissions, from the beginning of the study to the termination of a study, need to occur through the Advarra CIRBI Platform at CIRBI.net.
Do I have a point of contact for my study?
Yes. Advarra has a dedicated point of contact assigned to all your studies to ensure that any questions you have are rapidly addressed.
Does Advarra provide translation services?
Yes. Advarra can assist with certified translation using our approved vendor, or we can accept a valid certificate of translation. Please contact us for additional information.
Where do I go if I have questions about your online submission management system, CIRBI?
Please contact us.
What is an institutional biosafety committee (IBC)?
An institutional biosafety committee is a committee that reviews safety aspects of research involving recombinant DNA (genetic engineering), including:
- Risks associated with genetic modifications and experimental procedures
- Occupational and environmental safety
The committee must comprise at least five members who collectively have the expertise to assess risks associated with the proposed recombinant DNA research. At least two members must be local community members not affiliated with the institution/site.
Each IBC is registered with the NIH Office of Science Policy. IBC registrations are updated annually.
What does the IBC do?
The IBC is charged under the NIH Guidelines with assessing risks associated with research involving recombinant or synthetic nucleic acid (r/sNA) molecules. This includes:
- Assessing containment levels per NIH guidelines
- Evaluating the adequacy of facilities, equipment, personal protective equipment, SOPs, training and waste disposal practices
- Inspecting facilities involved in conducting the research
- Conducting post-approval monitoring, including review of safety reports and incident reports
When is IBC review required?
NIH Guidelines require IBC review when research involving recombinant DNA is:
- Funded by NIH, or
- Taking place at an NIH funded site
For clinical trials, IBC review takes place in addition to IRB review. Both committees focus on risk, but their purposes and mandates differ: While the IRB focuses on protecting the rights and welfare of human research participants, the IBC focuses on risks posed by recombinant DNA (genetically modified material) to study personnel, the community and the environment.
Who serves on an IBC?
An IBC comprises:
- A minimum of five members who collectively have the expertise to assess the risks associated with the proposed recombinant DNA research.
- At least two of the members must be local community members who are not affiliated with the institution/site. The community members represent the interests of the community in regard to public health and protection of the environment.
The IBC must be able to provide documentation to NIH Office of Science Policy that:
- The IBC has knowledge of local institutional characteristics — such as investigator training, laboratory conditions, and operating procedures, and
- An individual at the registering institution has the authority and responsibility to implement the IBC’s directives
This is accomplished through the IBC setup and registration process. Each IBC is registered with NIH, including member CVs. Registration is updated annually.
What is RAC review?
RAC review is the Recombinant DNA Advisory Committee (RAC) review process. RAC review is performed by the NIH Office of Science Policy (OSP).
The RAC is a panel of up to 21 national experts in various fields of science, medicine, genetics, ethics and patient perspectives that consider the current state of knowledge and technology regarding recombinant DNA research.
When is RAC review required?
RAC review of human gene transfer protocols is limited to cases in which the IBC or IRB at the initial study site for Phase I clinical trials determines that a protocol would significantly benefit from RAC review or has been determined to meet one or more of the following criteria:
- The protocol uses a new vector, genetic material or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; or
- The protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; or
- The proposed vector, gene construct or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight bodies involved to evaluate the protocol rigorously
This reflects the revised NIH Guidelines published in April 2016.
Even if the protocol does not meet the above criteria, the NIH director, in consultation (if necessary) with appropriate regulatory authorities, can select protocols for review that may present significant scientific, societal or ethical concerns.
Who decides when RAC review is necessary?
Either the IRB or the IBC at the initial study site for Phase I clinical trials involving human gene transfer can recommend RAC review.
Even if an oversight body involved in the review at an initial site does not request public RAC review, the NIH director, after consultation (if needed) with appropriate regulatory authorities, may initiate public RAC review if:
- The protocol has one or more of the characteristics listed above and public RAC review and discussion would provide a clear and obvious benefit to the scientific community or public, or
- The protocol otherwise raises significant scientific, societal or ethical concerns
How long does RAC review take?
If a protocol is to undergo RAC public discussion, a complete human gene transfer protocol package must be submitted at least eight weeks before the quarterly RAC meeting to be reviewed at that upcoming meeting. NIH publishes a list of upcoming RAC meetings online.
Advarra Accreditation and Compliance
Has your IRB ever been audited by the FDA, OHRP or any other government agency?
Chesapeake IRB (a founding Advarra company) has been audited by the FDA five times: 1998, 2000, 2004, 2009 and 2014. There were no significant findings in any of the audits and no FDA 483s were issued. Schulman IRB (a founding Advarra company) also has had a superior audit history with FDA, having completed six consecutive audits with no findings, including 1994, 1999, 2005, 2010, 2012 and 2016.
Is your IRB accredited?
Yes. A founding company of Advarra, Chesapeake IRB was one of the first independent IRBs to receive full accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been accredited since 2004. Likewise, Schulman IRB has been fully AAHRPP-accredited since 2008. Advarra continues to leverage this combined legacy of compliance excellence.
Is Advarra registered with the Office for Human Research Protections and FDA?
- US IRB Organization (IORG) Number: 0000635
- US IRB Registration Number: 00000971
- Canadian IRB Registration Numbers: 00000776 and 00005290
Please visit Accreditation and Compliance for more information.
What is a clinical study? Why are studies done?
Before a new treatment is approved and put on the market, it must undergo rigorous testing to ensure it is safe and effective. This testing is conducted as part of a clinical study, during which volunteers are given the prospective treatment — under strict guidelines and regulations that the researchers must follow. Besides safety and efficacy, clinical studies help researchers determine how much improvement the treatment offers participants, the proper dose and dosage form, how long the treatment takes to cause an improvement and much more.
Without clinical research, there can be no new treatments. Clinical studies are essential to advance health care.
How are they organized?
Clinical studies are done in steps or phases. Each phase looks at different questions:
- In Phase I studies, the study medicine is administered to people for the first time. Only a small number of people (usually between 20 and 80) are part of Phase I studies. Phase I studies focus on the safety of the study medicine and how much medicine may be safe to take in future studies.
- In Phase II studies, study doctors begin to look at the effect of the study medicine on disease and continue to study its safety. Usually between 100 and 300 people are in a Phase II study.
- Phase III studies are done to better understand the effectiveness and safety of the study medicine or treatment. Phase III studies include large groups of people (1,000 to 3,000 or even more) so that researchers can have a thorough understanding of the study medicine.
- Phase IV studies are done with medicines or treatments that can be prescribed for patients. Phase IV studies are conducted for many reasons, including to find out more about the safety of the medicine or to see how it works for other diseases.
How are study participants protected?
Clinical studies and the study doctors who work in them are regulated by the US government. The law requires that every study be reviewed by an independent group of scientists and community members, whose job is to make sure that the study is as safe for the volunteers as possible. This group is called an institutional review board or IRB.
You might consider volunteering for an IRB — these boards need community members and always need help to review studies. The IRB looks at the plan for the study (called the research protocol) before anyone can join the study. They may ask for changes in the study to make it safer for the people who participate. The IRB also looks at the participants’ confidentiality and privacy. If you join a study, measures must be in place to protect your private health information as well as your name and contact information. Your information will not be in any of the reports about the study. If new information that may be important to you and your decision about the study — especially information about safety — is discovered during the research, you will be informed.
Why join a study?
People have many reasons for joining a study. Some people like the feeling that, by joining, they are helping make new treatments available for all. They may feel that they are helping to improve medical care for the next generation. Many studies include health education and medical tests, which some people particularly like to have and join a study for this reason. Some studies need participants who are suffering from a disease or condition. In these cases, these people often participate hoping to find a better treatment.
What are the risks?
A study medicine is an untested or limited tested medicine. Clinical studies are done to test the study medicine or treatment. It is important to talk to your doctor and the study doctor about the study. Ask them what is known and what risks they see. And, when you have asked them all your questions, ask them what else you should ask.
All medicines have unpleasant side effects. Some people may experience the side effects, and others may not. Ask the study doctor about the kinds of side effects that may happen in the study.
The study likely will require appointments with the study doctor. Make sure that the schedule is convenient for you. If it isn’t convenient, ask the study doctor if it can be more flexible. These appointments are important for checking the effects of the study medicine on your health. Additionally, some studies may require overnight stays. Rest assured, researchers are required by law to tell you all about what is required before you agree to participate.
What are placebos?
A placebo is an inactive substance. Studies use placebos to compare with a drug or treatment to check the effectiveness of that drug or treatment.
How do I decide?
Talk with the study doctor and with your own doctor. Ask the study doctor to explain the study — including any details you would like to know. Be certain you ask all your questions. The study staff want you to feel comfortable with the study. Here are some questions you may want to ask:
- What will I have to do in the study?
- How long will it last?
- How many times will I have to come for study appointments?
- How long will the study appointments last?
- Who will be watching out for my health?
- What are the risks in the study?
- Will my transportation and parking be reimbursed?
Again, once you have asked every question you have, ask the study doctor what else you
What is informed consent?
The US government oversees medical studies that include people. One law ensures that no person can be forced to be in a clinical study or join against his or her will. Another law requires researchers to make sure that the people who join understand what to expect. Any person who joins a research study must consent to join, and that consent must be “informed.”
The study staff or doctor will give you an informed consent form to explain the study. Please take your time to read and understand it and be sure to ask about anything you don’t understand. If you like, you may take it home and have a family member or your doctor look at the form. If you decide to join the study, the study staff or doctor will ask you to sign the form to show that you understand what has been explained about the study. You will also be given a copy of the informed consent form to take home and keep.
Everyone who joins a clinical study has responsibilities to the study. These are some of the important responsibilities that study volunteers have:
- Come to the study appointments on time. If you have a conflict, please call and reschedule.
- You may be asked to take a medication or fill out forms at home. Please try to do this on schedule and follow the study doctor’s instructions.
- Always try to be honest when answering questions. If you had a headache, it is important for the study staff to know. If you don’t feel better, tell them. They want to know the truth. Ask the study staff what other responsibilities you may have in the study.
Everyone who joins a clinical study has rights. Ask the study staff about your rights in the study. The Informed Consent Form will also tell you about your rights. Some important rights are:
- You do not have to join a study.
- If you join, you can change your mind. You may leave a study at any time.
- You have a right to ask questions and have them answered to your satisfaction.
- Some studies reimburse volunteers for their time and transportation costs.
- You have a right to confidentiality and privacy. Your name and contact information will not be on any study report.
You may have questions about a specific study, an injury that you think might be related to research, the instructions you received or a payment. Ask the study doctor or staff all your questions. If you have questions about your rights, or if you have complaints, you can also contact the IRB listed on your copy of the Informed Consent Form.
How do I learn more?
Below are links you can visit for more information about clinical studies:
- The Center for Information and Study on Clinical Research Participation is a nonprofit organization that works to help the public understand clinical research. ciscrp.org
To find lists of US clinical research studies:
- Clinical studies are listed on a website run by the US government. You can use this site to find a study. clinicaltrials.gov
- The National Cancer Institute lists cancer studies on its site. cancer.gov/clinicaltrials
- The US Department of Veterans Affairs also works to educate veterans about clinical studies. research.va.gov/default.cfm
- The National Health Council is a group that works to improve health across the country. Its membership represents a breadth of disease-specific participant advocacy groups. nationalhealthcouncil.org
To find lists of Canadian clinical research studies:
- Health Canada’s Clinical Trial Database provides a public listing of Phase I, II and III clinical trials. https://health-products.canada.ca/ctdb-bdec/index-eng.jsp
- Health Canada encourages sponsors to register studies on ClinicalTrials.gov (run by US NIH). https://clinicaltrials.gov/
- The Canadian Institute for Military and Veteran Health Research (CIMVHR) works to educate veterans about clinical studies and research. https://www.cimvhr.ca/
Most medical schools offer information on clinical studies. You can also find information about research studies by searching the web for the participant support groups that meet your specific needs.
Pediatric and Adolescent Research
Can a child join a study?
Yes. Children can join studies, and they have an important role to help improve health care.
What should I do if someone asks me to consider a study for my child?
Talk to your child’s doctor. No one knows your child’s health better than his or her doctor. If your child’s doctor is not the study doctor, he or she may want to consult with the study doctor. Get all the information you need to help you decide whether the study may be a good idea for your child.
Where do I go if I am looking for a study for my child?
Ask your doctor. Search the internet. If your child has a chronic or serious disease, ask a support group for that disease.
Will my child be safe in a study?
Government regulations require that studies including children receive special scrutiny. The IRB will carefully evaluate a study of children to assess the risks compared to potential benefits.
What else should I consider?
Ask your child. Explain the reasons for the study and what he or she will have to do. If you have questions, ask the study doctor, and ask him or her to speak with both you and your child. If your child doesn’t want to be in the study, don’t try to persuade him or her. No one should ever feel forced to join a study — including your child.
What is a child's assent? Is it required under FDA regulations?
In pediatric studies, the investigator must obtain, in addition to written permission from the child subject’s parent(s) or legal guardian, the child’s affirmative agreement or “assent” before the child may participate in the study. (A child’s mere failure to object is not assent.) Assent must be obtained from children who are capable of understanding the concepts involved in the research and should usually be obtained from any child with an intellectual age of seven years or more. Thus, in addition to explaining the study to the parents, the investigator must explain the purpose, risks and benefits to the child at a level appropriate to the child’s intellectual age, and the child must affirmatively agree to participate. Under the FDA regulations, the Board must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the Board the children are capable of providing assent.
Can a child's assent ever be waived?
Yes, assent may be waived if the IRB determines:
- (a) that the capability of some or all of the children is so limited that they cannot reasonably be consulted; or
- (b) the research presents a prospect of direct benefit that is important to the health or well-being of the child or children and is available only in the context of the research study.
The IRB may also waive assent of children who are capable of assenting if:
- (a) the clinical investigation involves no more than minimal risk to the subjects; and
- (b) the waiver will not adversely affect the rights and welfare of the subjects; and
- (c) the clinical investigation could not practicably be carried out without the waiver; and
- (d) when appropriate, the children will be provided with additional pertinent information after participation.
Does the IRB review pregnant partner consents?
Yes. When the protocol includes plans to collect information from a subject’s pregnant partner, a pregnant partner consent form should be submitted with the initial submission for review. It may also be submitted during the course of the study. In addition to meeting all other consent form requirements, the pregnant partner consent form should address the information to be collected and the length of time the information will be retained, consistent with the protocol.
Does Advarra provide sites with approved HIV consents when HIV testing is explicitly required by the protocol or when the protocol allows for HIV testing at the investigator’s discretion?
No. It is Advarra’s expectation that the principal investigator will assume the responsibility of being aware of and ensuring compliance with state/provincial laws and/or regulations regarding HIV testing when HIV testing is explicitly required by the protocol or when the protocol allows for HIV testing at the investigator’s discretion. Advarra recommends that Canadian sites consult with their provinces’ health officials and/or legal counsel to assist in determining the provinces’ laws and/or regulations pertaining to HIV testing. Advarra recommends that US sites consult with their state’s department of health and/or legal counsel to assist in determining the state’s laws and/or regulations pertaining to HIV testing.
If a site intends to use a separate consent to obtain consent for HIV testing as part of a study, is it necessary to submit that consent to Advarra for review and approval?
No. This is not necessary as long as the separate consent does not contain study-specific information.
Who has to sign and date the IC?
The subject or the subject’s legally authorized representative (LAR) and the person conducting the consent discussion and, if applicable, an impartial witness must sign and date the ICF.
Can a research site use a screening consent for screening tests and procedures prior to having subjects sign a study-specific informed consent form (ICF)?
Yes. A screening consent may be used only for minor screening procedures, such as a physical exam, blood draw, chest X-ray or medical history. If a potential subject qualifies after the screening procedures, a study-specific ICF must be given to the subject.
Why might the IRB request modifications of the ICF?
Under federal regulations, the IRB has the authority to request modifications to the submitted ICF. The IRB may seek modified language to ensure that the document includes the required elements of informed consent. The IRB may also suggest changes to an ICF to make it easier to read and/or be more understandable to a study subject.
Can I receive an electronic copy of the informed consent form (ICF)?
Advarra’s CIRBI Platform provides a downloadable PDF version(s) of the study’s ICF. If a sponsor or CRO is obtaining a translated consent(s) for its sites, Advarra will send a Microsoft Word document version of the ICF upon request. After approval documents have been sent to the appropriate parties, Advarra provides the sponsor/CRO with the electronic version of the ICF, with Track Changes enabled, for future revisions due to amendments, etc.
How does Advarra evaluate compensation for subjects participating in research?
Compensation is evaluated by the IRB on a study-by-study basis. Please review the schedule of visits outlined in the protocol before deciding compensation amounts. Compensation should be pro-rated and based on time and inconvenience to the subject. See FDA Guidance on Paying Research Subjects.
What are the differences between a legally authorized representative (LAR) and a caregiver?
A LAR “stands in the shoes” of the decisionally impaired person and makes decisions on his/her behalf. Who may act as a LAR varies with the law of the state/province in which the research is being conducted. Therefore, the research staff should be familiar with its own state/provincial law in this area.
A research study may require the involvement of the subject’s caregiver. The caregiver may or may not be the subject’s LAR. It is the Investigator’s responsibility to determine if the caregiver has the authority to act as a decisionally impaired subject’s LAR under your state’s/province’s law.
Can informed consent be obtained from a legally authorized representative (LAR) over the telephone?
A verbal approval does not satisfy the requirement for a signed consent, as outlined in 21 CFR 50.27(a). However, it is acceptable to send the ICF to the LAR by email or other means, and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he or she can sign and return the signed ICF to the clinical investigator.
Does a study being conducted in a hospital have to be reviewed by the hospital's IRB?
No, it does not. The hospital can assign jurisdiction to another IRB, but it must be done in writing.
How will Advarra interact with my local IRB or research office?
Advarra will work closely with the institution to ensure that institutional requirements (informed consent language, reporting requirements, etc.) are appropriately addressed. Additionally, Advarra can provide the local IRB/research office with access to all approval documents via the Advarra CIRBI Platform. Other support and training services are also available.
How does Advarra ensure that it provides meaningful consideration of relevant local factors for communities from which research subjects will be drawn?
Advarra relies on the documentation provided by the institution regarding local considerations. Additionally, the IRB composition represents a diverse spectrum of expertise and perspectives that contribute to a thoughtful and meaningful review for the protection of human subjects.
Do I need to submit an IRB Authorization Agreement?
If the research being proposed is either federally funded, or the current FWA covers all research conducted at your institution (regardless of funding), an IRB Authorization Agreement or other formal agreement must be included in the submission or on file with Advarra.
Federally Funded Research/FWA
My study is federally funded. Does Advarra review federally funded studies?
Yes, Advarra’s IRB reviews federally funded studies.
How can I find my Federalwide assurance number?
Please visit the OHRP Federalwide Assurance (FWA) database and follow the instructions provided.
Does my Federalwide assurance number cover federally funded research only or is all of the non-exempt research at my site/institution covered by our Federalwide assurance?
Are IRBs required to have Federalwide Assurances?
No. Only institutions that receive federal funding for human subject research are required to have Federalwide Assurances (FWAs) on file with the Office for Human Research Protections (OHRP). IRBs reviewing research must be registered with OHRP and FDA.
An FWA is a written document by which an institution agrees to comply with appropriate ethical standards and the standards set forth in the federal regulations at 45 CFR 46.
What is different about Department of Defense (DoD) research?
DoD follows the Common Rule, however 32CFR219 adds other requirements. Each DoD component may apply different policies, such as the DoD Addendum to FWA required by the Navy, to address those requirements. Call Advarra, contact the funding point of contact, or reference the following websites for more information:
When am I required to submit a Study Status Report?
Sponsors and CROs are required to submit continuing review approximately six to eight weeks prior to the expiration of the study to allow adequate time for Board review of the study. Sites (or sponsors/CROs on behalf of sites) are required to submit a periodic review at least four weeks prior to the site’s expiration date.
Is a sponsor/CRO closeout visit required prior to submitting a Final Report or Routine Termination to Advarra?
Advarra does not require a sponsor/CRO closeout visit prior to receiving a Final Report. However, please verify with the sponsor/CRO whether your site can be closed with the IRB prior to submitting your Final Report/Routine Termination to Advarra.
Research in California
Can Advarra provide a copy of the California Experimental Research Subject's Bill of Rights?
Yes, English and a variety of translated versions of the California Bill of Rights are available for download on Advarra’s CIRBI Platform. For additional languages, please contact Translations.
Does Advarra require the California Experimental Research Subject's Bill of Rights to be signed?
California’s “Protection of Human Subjects in Medical Experimentation Act” and California Health and Safety Code, Section 24173(a) require that the California Experimental Subject’s Bill of Rights be given to subjects prior to conducting the initial protocol-specific consent process and that it is signed and dated.
Does a California Experimental Research Subject's Bill of Rights need to be signed again when a consent form is revised?
No, it only needs to be provided and signed at the time of initial consent, prior to conducting the initial protocol-specific consent process.
Does California have requirements for informed consent forms?
Yes, the requirements are for HIPAA Authorizations.
According to the Confidentiality of Medical Information Act California Civil Code Section 56.11 (b), the Authorization must be clearly separate from any other language present on the same page and executed by a signature which serves no other purpose than to execute the authorization. Additionally, the HIPAA Authorization must be presented in 14 point font.
In order to satisfy the California requirements and maintain a consistent document for all states, please consider placing the HIPAA Authorization at the end of the consent with its own signature lines and in 14 point font.
An expiration date of 50 years is also required. Advarra suggests the following text: “Your HIPAA Authorization will expire 50 years from the date you sign it unless you revoke (cancel or withdraw) it sooner.”
Are all clinical trials registered on ClinicalTrials.gov?
No. Only “applicable” clinical trials require registration. See ClinicalTrials.gov FAQs for the definition of which trials require registration and which trials are generally excluded from registration.
For a ClinicalTrials.gov registration, what information should I enter about Advarra?
When registering study at ClinicalTrials.gov, Advarra suggests the following responses:
- Board Approval – select one of the following as applicable
- Request not yet submitted
- Submitted, pending
- Submitted, approved
- Submitted, exempt
- Submitted, denied
- Submission not required
- Approval Number – Enter the Advarra approval date (mm/dd/yyyy)
- Board Name – Advarra
- Board Affiliation – Independent
- Board Contact – 410.884.2900
For more information, please refer to item #4 on the ClinicalTrials.gov Definitions page.