Do I need an IBC review for my NIH study?
This means any funding—even $1 of NIH funds for the site or the study means the study must be reviewed by an IBC. Studies and sites completely independent of NIH funding may still require IBC review if the R&D that led to the investigational product was funded by the NIH.
Do you need an IBC for gene therapy?
NIH Guidelines require IBC review for any genetic engineering research, including gene therapy research, that receives NIH funding or takes place at sites receiving NIH funding. This means any funding—even $1 of NIH funds for the site or the study means the study must be reviewed by an IBC.
What is the prognosis of triple negative IBC?
Triple negative IBC are hormone receptor-negative and HER2-negative. Triple negative IBC and IBC that are hormone receptor-positive and HER2-negative tend to have a worse prognosis than other IBC [ 158,166 ].
How can an IBC help researchers?
An IBC can help researchers utilize the appropriate safety measures to ensure research is conducted safely and responsibly. Certain key words can aid in determining if IBC review is likely required.
When do you need IBC approval?
NIH Guidelines require IBC review for any genetic engineering research, including gene therapy research, that receives NIH funding or takes place at sites receiving NIH funding. This means any funding—even $1 of NIH funds for the site or the study means the study must be reviewed by an IBC.
What is IBC approval?
IBC Approval The outcome of IBC review consists of confirmation of the appropriate biosafety containment level for the work. IBC review will also cover the animal housing containment level, if applicable.
How often does IBC review registrations?
When will the IBC review my registration form? Registrations or addendums submitted by the 25th of the month will be reviewed at the following month's IBC meeting. For example, a registration submitted on June 15 will be reviewed at the July meeting.
What types of biological materials need to be registered and approved by the IBC?
Materials that Require IBC ApprovalBiohazardous and Potentially Infectious Materials. ... Recombinant or synthetic nucleic acid materials. ... Use of Animals. ... Tissue Culture/Cell Lines. ... Select and Biological Toxins.
How do I get IBC approval?
In order for the IBC to issue approval for work at BSL2 containment, the laboratory where the work will be performed must have had a satisfactory biohazard inspection by U-M Environment, Health & Safety (EHS) within the past 12 months (including the resolution of any corrective action items).
What does the IBC do?
What is the role of the Institutional Biosafety Committee ( IBC)? The IBC is responsible for monitoring and ensuring compliance as well as review and approval of all research projects that involve biological material including rDNA materials and human gene therapy/gene transfer protocols.
How long does IBC approval last?
three yearsHow long does an IBC registration approval last? IBC registrations are approved for three years.
What does IBC mean in clinical trials?
Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules.
What is IBC biosafety?
The Institutional Biosafety Committee (IBC) reviews, approves and oversees research involving the use of recombinant or synthetic DNA/RNA and other biohazards. All work involving biohazards, including recombinant or synthetic DNA/RNA, is reviewed by the Institutional Biosafety Committee (IBC) and EH&S.
What is an IBC registration?
The IBC registration process solicits information to describe how biological materials are being used in the lab, the source and nature of the DNA constructs, host/vector systems, potential risks to human health and the environment with emphasis on practices, as well as engineering controls used to contain potentially ...
What are NIH guidelines?
The purpose of the NIH Guidelines is to specify the practices for constructing and handling: (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, ...
Which committee's must approve research involving mice that will not be exposed to any recombinant DNA infectious agents or potential biohazards?
What is the role of the Institutional Biosafety Committee (IBC)? The IBC is responsible for monitoring and ensuring compliance approval of all research projects that involve biological material including recombinant DNA materials and human gene therapy/gene transfer protocols.
What is the next step in chemo?
Surgery and further treatments. If the cancer improves with chemo, surgery is typically the next step. The standard operation is a modified radical mastectomy, where the entire breast and the lymph nodes under the arm are removed. Because IBC affects so much of the breast and skin, breast-conserving surgery (partial mastectomy or lumpectomy) ...
What is the treatment for stage IV breast cancer?
Treating stage IV inflammatory breast cancer. Patients with metastatic (stage IV) IBC are treated with systemic therapy. This may include: Chemotherapy. Hormonal therapy (if the cancer is hormone receptor-positive) Targeted therapy with a drug that targets HER2 (if the cancer is HER2-positive) One or more of these treatments might be used.
What is chemo before surgery?
Using chemo before surgery is called neoadjuvant or preoperative treatment . Most women with IBC will receive two types of chemo drugs (although not necessarily at the same time): An anthracycline, such as doxorubicin (Adriamycin) or epirubicin (Ellence) A taxane, such as paclitaxel (Taxol) or docetaxel (Taxotere)
What is the treatment for cancer with HER2?
If the cancer is HER2-positive (the cancer cells make too much of a protein called HER2), the targeted therapy drug trastuzumab (Herceptin) is usually given, sometimes along with another targeted drug, pertuzumab (Perjeta). These drugs can lead to heart problems when given with an anthracycline, so one option is to give the anthracycline first (without trastuzumab or pertuzumab), followed by treatment with a taxane and trastuzumab (with or without pertuzumab).
How long does radiation last after breast cancer surgery?
Radiation is usually given 5 days a week for 6 weeks, but in some cases a more intense treatment (twice a day) can be used instead. Depending on how much tumor was found in the breast after surgery, radiation might be delayed until further chemo and/or targeted therapy (such as trastuzumab) is given.
How long does radiation treatment last after breast surgery?
If breast radiation isn’t given before surgery, it is given after surgery, even if no cancer is thought to remain. This is called adjuvant radiation. It lowers the chance that the cancer will come back. Radiation is usually given 5 days a week for 6 weeks, but in some cases a more intense treatment (twice a day) can be used instead. Depending on how much tumor was found in the breast after surgery, radiation might be delayed until further chemo and/or targeted therapy (such as trastuzumab) is given. If breast reconstruction is to be done, it is usually delayed until after the radiation therapy that most often follows surgery.
How to treat stage 3 inflammatory breast cancer?
IBC that has not spread outside the breast or nearby lymph nodes is stage III. Treatment usually starts with chemotherapy (chemo) to try to shrink the tumor. If the cancer is HER2-positive, targeted therapy is given along with the chemo. This is typically followed by surgery (mastectomy ...
What is the first treatment for IBC?
The first treatment for IBC is neoadjuvant chemotherapy, usually with an anthracycline-based chemotherapy and a taxane-based chemotherapy. Neoadjuvant chemotherapy helps shrink the tumor (s) in the breast and lymph nodes so surgery can better remove all the cancer.
What are the symptoms of IBC?
Warning signs of IBC. Warning signs of IBC include [ 157-158 ]: Swelling or enlargement of the breast. Redness of the breast ( may also be a pinkish or purplish tone) Dimpling or puckering of the skin of the breast. Pulling in of the nipple. Breast pain. See images of these warning signs.
What is the best treatment for HER2 positive breast cancer?
HER2-positive breast cancers can be treated with chemotherapy and with trastuzumab (Herceptin) and other HER2-targeted therapies. So, women with HER2-positive IBC tend to have better survival than women with HER2-negative IBC [ 157-158,166 ].
How to contact Komen Breast Care?
If you or a loved one needs information or resources about clinical trials, call the Komen Breast Care Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email [email protected]. The Helpline offers breast cancer clinical trial education and support, such as: Knowing when to consider a trial.
What percentage of breast cancers are IBC?
About 1-5 percent of breast cancers in the U.S. are IBC [ 157-158 ]. Women with IBC tend to be diagnosed at a slightly younger age than women with other breast cancers [ 157-158 ]. Some women are more likely than others be diagnosed with IBC, including [ 157-161 ]: Black and African American women. Women who are obese.
How many women have metastases with IBC?
About one-third of women with IBC have metastases when they are diagnosed [ 158 ]. This means the cancer has spread beyond the breast and nearby lymph nodes to other parts of the body such as the bones, lungs, liver or brain.
How long does it take for a lump to appear in breast cancer?
Sometimes a lump can be felt, but it’s less common with IBC than with other breast cancers. Signs of IBC tend to arise quickly, within weeks or months. With other breast cancers, warning signs may not occur for years. If any of the changes above last longer than a week, tell your health care provider.
How to treat IBC?
The usual treatment for IBC starts with chemotherapy (chemo). Chemo is the use of drugs for treating cancer. The drugs can be swallowed in pill form, or they can be injected by needle into a vein or muscle. Because the drugs enter the bloodstream and circulate throughout the body to reach and destroy cancer cells wherever they are, chemotherapy is considered systemic therapy. Systemic treatments can destroy any cancer cells that break off from the main tumor and travel in the bloodstream to lymph nodes or distant organs.
How to diagnose IBC?
Like any other type of breast cancer, the diagnosis of IBC is made by a biopsy -- removing a sample of the breast tissue and looking at it under the microscope. Other tests may show findings that are "suspicious for" IBC, but only a biopsy can tell for sure that cancer is present. Breast biopsies can be done in many ways. Samples of breast tissue can be removed using fine needle aspiration, large core biopsy, vacuum assisted biopsy, or open (excisional or incisional) biopsies -- depending on where the affected area is, what it looks like, and who finds it. A biopsy in IBC often involves a needle biopsy under ultrasound guidance. IBC can also be diagnosed with a skin biopsy.
What is the best test for IBC?
Often a breast ultrasound is ordered as well. The mammogram may show thickened skin, often without a visible mass (tumor). It may also show that the affected breast is larger than the other as well as increased breast density. The ultrasound is often able to show that lymph nodes under the arm are enlarged and may find breast masses (tumors) if they are present. Ultrasound can also be useful in guiding a needle for a biopsy procedure. MRI (magnetic resonance imaging) is the most sensitive imaging test for IBC. It can find any breast mass that looks like it could be invasive cancer. More importantly, MRI allows the skin changes that are typical of IBC to be measured precisely.
What is the best way to find IBC?
This test is often combined with a CT (computed tomography) scan. It can be useful in finding areas of cancer spread to lymph nodes and distant sites. PET/CT is one of the best ways to find IBC that has spread to the nearby and distant lymph nodes, which are among the most common sites of IBC spread.
How long does it take to live with inflammatory breast cancer?
According to data from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database, for women who were diagnosed with inflammatory breast cancer between 1988 and 2001, the 5-year relative survival rate was about 40%. This compares with about 87% for all breast cancers combined. These numbers are among the most current available, but they were based on patients treated at least several years ago. Improvements in treatment since then mean that the survival rates for women now being diagnosed with these cancers may be higher.
Can Tykerb be given alone?
In this study the lapatanib was given alone, without other chemo drugs. It caused the tumors to shrink in many of the women treated. Further studies using this drug to treat IBC are going on now.
Is IBC spread to lymph nodes?
IBC grows quickly and it is more likely to have spread to nearby lymph nodes at the time it is found than other types of breast cancer. The prognosis (outlook) is generally not as good as it is for other types of breast cancer.
Is IBC registration based on funding?
Yes. Registration with the IBC is based on the biological materials used in your experiments, not on funding.
Is IBC registration required?
Yes. IBC registration and approval of research involving these biohazards is required. Biohazards includes the following:
Is IBC required for biohazardous materials?
Yes. IBC oversight is required for ANY use of biohazardous materials regardless of their use in research or teaching activities.
How long does IVIG take?
How long do infusions take? The length of the infusion depends on a few factors. IVIG generally takes about 3 hours for the infusion to be completed.
How to reduce pain of IV catheter?
Providers often have many ways to decrease the pain of inserting an IV catheter, including using numbing creams and sprays, distraction techniques and devices which provide physical pain blocking using cold and vibration. Check with your doctor to see which pain control plan might work best for you.
What is IVIG therapy?
Preparing for Intravenous Immunoglobulin (IVIG) Infusion Therapy. What is infusion therapy? Infusion therapy involves the administration of medication through a needle or catheter. It is given when a patient’s condition cannot be treated with oral medicine. Typically, infusion therapy means that a drug is given intravenously (IV) ...
What is IVIG for PIDD?
Patients with a Primary Immunodeficiency Disease (PIDD) may need to be treated with intravenous immunoglobulin (IVIG). Many different preparations of IVIG are available from different companies. You should work with your doctor to identify which product will work best for you.
Does insurance cover infusion therapy?
You, your infusion therapy provider and your physician will work with your insurance company to determine coverage for your infusions.
Can infusion therapy be long term?
Some people have a disease that may need intermittent or long-term treatment. Infusion therapy can enhance your overall health and can provide you with treatment that can be life-sustaining.
Can IVIG cause headaches?
With IVIG, you may develop a headache during or after your infusion. Some people also feel cold during the infusion and often ask for a blanket. You may also feel more tired or have muscle aches or fever after your infusion and need to rest for a day before feeling like your usual self. Other potential side effects exist, but these events represent the most common ones. Please talk to your doctor about any side effects that you may experience from your infusion.
How long do IBC protocols have to be approved?
All protocols are due at least two weeks prior to an IBC meeting for review- this does not guarantee an approval, only that it will be reviewed at that monthly meeting. Plan on 2 months for approval because it may require revisions prior to approval.
How to register for IBC?
Go to the IBC Protocol Registration Forms and Submission Page to download the forms and submit the forms. If you have additional documents or are having difficulty with the download, please submit your materials to [email protected] for IBC evaluation.
What is an IBC?
The IBC is responsible for monitoring and ensuring compliance as well as review and approval of all research projects that involve biological material including rDNA materials and human gene therapy/gene transfer protocols. IBC’s were established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA .
What to do if your protocol has been terminated?
If your protocol has been completed or terminated, please notify the biological safety officer of the completion of the protocol. If the protocol lapses and has not been renewed, this may pose a problem for continuing work in the laboratory until the protocol has been reviewed and renewed.
How long does it take for a biological safety officer to review a protocol?
After the IBC has reviewed the protocol, the PI will recieve notice from the biological safety officer within 2-7 days of the meeting. This will be an electronic notice with an notification letter, approved/ rejected protocol, and/ or request for additional information. Final approval is contingent on the speed in which questions are resolved if they need to be completed prior to full approval.
How far in advance should you renew your protocol?
If this is a renewal, you should submit your protocol 60 days before the expiration date. The biological safety officer will try to send reminders to the PI via e-mail 90, 60, and 30 days in advance, but it is the responsibility of the PI to know deadline dates.
Does UWM require IBC approval?
All biological research at UWM is required to be registered with the IBC- not all will require IBC approval (but some may, depending on the type of research being conducted).
Why do we need an IBC?
An IBC can help researchers utilize the appropriate safety measures to ensure research is conducted safely and responsibly. Certain key words can aid in determining if IBC review is likely required. The following is a list of common terms found in research protocols requiring IBC review: Likely Needs IBC Review.
What is monoclonal antibody therapy?
Monoclonal antibody based therapy. (Anything with a name ending in “Mab”) Tests that do not involve extraction and manipulation of genetic material (e.g. routine blood or urine tests) If you’re still unsure about whether your study requires IBC review, contact your IBC office for assistance.
What is the fastest growing area of clinical research?
One of the fastest growing areas in clinical research is clinical trials involving recombinant DNA, or gene therapy research. It’s an exciting space that is full of promise, but because of the risks involved, it’s also a highly regulated space.
What is the role of IRB in clinical research?
While clinical research professionals are familiar with the role of the IRB to protect research subjects, most are unfamiliar with the added need for an Institutional Biosafety Committee (IBC) to review the risks associated with engineered genetic material in clinical trials.
Does NIH require IBC review?
NIH Guidelines require IBC review for any genetic engineering research, including gene therapy research, that receives NIH funding or takes place at sites receiving NIH funding. This means any funding—even $1 of NIH funds for the site or the study means the study must be reviewed by an IBC.
How much improved is IBS?
With the new antibiotic treatment, Pimentel tells WebMD, many participants ''say they are 80% improved, 90% improved, that kind of results. The stool was more solid, the diarrhea goes away, and the bloating is much less.". That can translate to big changes in the lives of those with IBS, estimated to affect about 15% of adult Americans.
How long does Xifaxan last?
5, 2011 -- A two-week course of the antibiotic rifaximin ( Xifaxan) helps to relieve the symptoms of irritable bowel syndrome ( IBS ), and the relief lasts up to 10 weeks after stopping the medication, according to new research.
What are the symptoms of IBS?
For those with this type of IBS, symptoms can include abdominal pain, bloating, and changes in bowel function such as diarrhea.
How much of the placebo group did bloating relief?
While 40.2% of those on the drug had relief from bloating, 30.3% of those in the placebo group did.
Can antibiotics be reserved for small intestine?
For now, he suggests that the antibiotic be reserved for those patients in whom overgrowth of the small intestine bacteria has been confirmed, or to limit treatment to a single cycle for those not responding to other medications.
Can IBS be used for diarrhea?
With the drug treatment, Pimentel says, those with the IBS ''can enjoy social outings without the worry of having to run to the bathroom and having diarrhea.". The drug is approved by the FDA only for traveler's diarrhea and hepatic encephalopathy, a brain disorder caused by chronic liver failure .