Standard Language

Compendium: Explanations of Common Procedures and their Associated Risks

The document Explanations of Common Procedures and their Associated Risks contains the complete listing of procedure descriptions and their associated risks. The document can be downloaded either as a pdf document or as an a MS Word document. The descriptions were culled from language from IRB-approved consent forms. The wording in the procedures and the associate risks should be used as starting points; the IRB expects that investigators will edit the wording as needed to meet the requirements of their study. The objective should be to provide the amount of information that a reasonable person would want to know, written at a Grade 6 - 8 reading level. The information below includes a partial listing of common risk language.

Risk Statements for Some of the More Common Procedures

Blood Draw / Venipuncture Taking blood may cause some pain, bleeding or bruising at the spot where the needle enters your body. Rarely, taking blood may cause fainting or infection.
Blood Transfusion

Blood products come from voluntary donors who are carefully selected and tested. There are still some risks to blood transfusion. These risks are uncommon and are usually mild, but may be severe or life threatening.

  • Occasional risks include: fever and allergic reactions due to the formation of antibodies (formed by the body to fight infections).
  • Less common risks include: infections with viruses, such as hepatitis and fluid overload
  • Very rare but serious reactions include: reactions due to a mismatch between the donor's blood and the recipient's and serious infections including HIV (the virus that causes AIDS)

(Include this statement if applicable) The alternative to volunteer donor blood is directed donor blood donated by a family member or friend, if appropriate for your disease.

Bone Marrow Aspirate

This test may be painful. The pain normally lessens within minutes to hours. Local anesthetic medications will be used to decrease the pain. (Include the former, only if applicable) There is also a small risk of infection or bleeding.

Breach of Privacy and Confidentiality

As with any study involving collection of data, there is the possibility of breach of confidentiality of data. Every precaution will be taken to secure participants' personal information to ensure confidentiality.

At the time of participation, each participant will be assigned a study identification number. This number will be used on (include items as applicable) data collection forms, blood samples, tissue specimens and in the database instead of names and other private information. A separate list will be maintained that will links each participant's name to the study identification number for future reference and communication.

Echocardiogram (Echo) Echos are very safe. The gel may feel cold when it is first placed. Some people with sensitive skin can develop a rash from the gel.
Electrocardiogram (EKG or ECG) There is a small risk that redness or swelling could develop from the ECG electrodes (pads) that will be placed on the chest.
Eye Examination

There is very little risk of harm from eye examination. (Add this statement if applicable) Eye drops will be needed to make the pupils larger. This may make your vision temporarily blurry and very sensitive to light. You will be given dark glasses to wear.

(Include this statement if applicable) Some types of glaucoma may be made worse by dilating drops. If you have high blood pressure or a history of heart disease, in rare instances, dilating drops may make irregular heartbeats or high blood pressure worse. All of these side effects can be treated, if necessary.

Deliberate Hypothermia

The following are the most common side effects of hypothermia:

  • slow and irregular heartbeat,
  • less oxygen supplied to the heart muscle,
  • problems with clotting of blood,
  • infections, especially pneumonia,
  • high blood sugar levels,
  • shivering,
  • skin changes and
  • rapid changes in the blood levels of salts.

These side effects are most common when body temperature was lowered below 32 degrees Celsius or 92.3 degrees Fahrenheit. This is cooler than the body temperatures that will be used in this study. These side effects are also common whenever a person is very ill and needs intensive care.

Your child will be monitored closely for these problems and will be treated promptly if they occur. While your child is being treated, his/her heart rate and breathing will be closely monitored. We will frequently check blood sugar and salt levels. We will administer sugar (glucose) in the iv fluids to help him/her recover and we will also monitor for infection.

At the end of the hypothermia treatment, your child will be warmed slowly back to normal temperature. Some reports suggest that seizures and low blood pressure may be more likely to happen during this time of re-warming.

Insertion of an Intravenous Catheter (IV) Placing an IV may cause some pain, and bleeding or bruising at the spot where the needle enters your body. Rarely, it may cause fainting. The longer an IV catheter is left in place, the more common it is for redness or infection to develop.
Questionnaires and Surveys There are no physical risks but you might experience momentary embarrassment or discomfort. You do not have to answer any questions that make you too uncomfortable. (Add a statement, if applicable, to discuss any counseling that may be available as a result of concerns that are raised.)
Reproductive Risks

This risk section should go as a sub-section under the procedure associated with that risk. For example, it should go as a subsection in the Risks of Study Drug. The procedures needed to prevent pregnancy belong in the Procedures Section.

The effects of the study drug/radiation/etc. on the developing fetus are unknown. It is possible that it may harm the fetus. (Explain the potential harms, if known of the study drug, radiation, etc. on the fetus.)

Upper GI Endoscopy Possible risks and discomforts associated with the endoscopy procedure include gagging, nausea, vomiting, sore throat and possible reaction to the numbing medicine used during the procedure. There are other less common risks of endoscopy. (if GI endoscopy will be done by someone who isn't an investigator, add this statement) The doctor performing the endoscopy will explain these risks to you in more detail before you have the endoscopy procedure.

Risk Statements for Genetic Research

Genetic Testing/Analysis

The risks related to genetic analyses can be to individuals or groups. These harms include stigmatization and insurability. (if applicable add) To reduce this risk, your samples will be stored and labeled with a code number. (if applicable add) If the results are used for future research, the researchers will not be able to identify you. Information about this study will not be recorded in your medical record.

There is a Federal law, called the Genetic Information Nondiscrimination Act (GINA), which generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law may protect you in the following ways:

  • Health insurance companies and group health plans may not request your genetic information that we get from this research.
  • Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
  • Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

This Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

There may be other risks that are not known at this time. Tell the study investigator or study staff right away if you have any problems.

If applicable, add:
New information about parentage may be discovered by this research. This could include unknown adoption and paternity (fatherhood). These types of findings will not be shared with you unless there are medical concerns. We will not reveal this information to any third party, including other family members.

Sharing Genetic Results (with national databases) We may wish to share your data or DNA samples with other investigators or national databases. The NIH maintains a national database for genetic material. They collect samples for future research. The shared information will not include information that can identify you. The shared information will include information about your diagnosis and genes. If you withdraw consent for sharing, your information or samples that are still at CHOP will be removed and will no longer be used for future research. However, data and samples that have already been shared with other researchers cannot be taken back.

Risk Statements for Radiology Procedures

Ionizing Radiation
General Statement for Ionizing Radiation This study involves exposure to radiation from a name of procedure. You will therefore receive a radiation dose. This dose is not necessary for your medical care. You will get the radiation only because you are taking part in this study. Radiation can increase the risk of cancer after many years but at a dose much higher than you will get. Because of the low dose of radiation, it is very likely that you will see no ill effects.
Contrast Agent (add when applicable) You will receive a contrast agent as part of your name of procedure. Contrast agents can cause allergic reactions and kidney damage. Allergic reactions can include mild itching associated with hives and can be as serious life-threatening emergency from difficulties breathing. If this occurs, it is treatable.
DXA and pQCT Scans This research study involves exposure to a small dose of radiation from a name of procedure. This radiation dose is not necessary for your medical care and will occur only as a result of your participation in the study. At doses much higher than you will receive, radiation is known to increase the risk of developing cancer after many years. At the doses you will receive, it is unlikely that you will see any effects at all.
Non-Ionizing Radiation
Magnetic Resonance Imaging (MRI)

There are no known risks of physical harm associated with MRI. However, MRI machines produce loud banging noises, which cause some people to become stressed or upset. You may also feel uncomfortable inside the magnet if you do not like to be inside small places or have difficulty lying still.

The MRI magnet is always on and attracts certain metal objects. Any metal objects on or inside of your body may heat up, move, and/or not function properly within the scanning room. Metal objects in the room can fly through the air toward the magnet and hit those nearby. There are many safety measures in place to reduce these risks. The staff will screen all persons and materials entering the scanning room for metal. When the study begins, the door to the room will be closed to minimize the risk of someone accidentally bringing a metal object into the scanner room.

Risk Statements for General Anesthesia and Sedation

General Anesthesia You (may) will need GA in order to have a (name of procedure). There are very rare but serious side effects associated with general anesthesia including: irregular heartbeat, increases or decreases in blood pressure, rare reactions to medications used in the anesthesia, and blockage of breathing passages. Other rare complications include nerve injury, lung injury, heart attack and brain damage. An extremely rare but serious complication is rapid increase in body temperature. All of these complications are treatable but might lead to coma or even death. You will have an opportunity to discuss these risks with the anesthesiologist.
Sedation Sedative medicines may make you sleep for several hours and sometimes can have prolonged effect. Uncommon but serious complications include: irregular heartbeat, increases or decreases in blood pressure, rare reactions to medications used, and blockage of breathing passages. All of these complications are treatable but rarely, may lead to coma or even death. Emergency personnel and equipment will be available in the event of a serious adverse reaction to sedation. You will have an opportunity to discuss these risks and the specific drugs that will be used with the nurse or doctor who will supervise the sedation.
General Anesthesia or Sedation: Children less than 3 years of age If the study will involve infants less than 3 years of age the FDA has required – for investigator-held IND studies – to include the following warning statement about the potential for neurotoxicity due to anesthetic and sedative drugs:

In neonatal and infant animals, sedative and anesthetic agents adversely affect brain development. This includes loss of brain cells. This may result in long-term changes that may be permanent in learning and behavior. For the most part, these effects happen after prolonged periods of sedation or anesthesia (greater than 3 hours). These effects also appear when rapid brain development is taking place. In children, this is when they are less than 3 years of age. It is not known if similar adverse effects occur in humans.

You should know that anesthetic drugs are needed to perform your child’s procedure. They may have the potential to increase the loss of nerve cells in their developing brain. The clinical significance of any such changes is not yet known.
Transport under General Anesthesia During transport to and from location #1 to location #2 there is a small risk that the breathing tube or an intravenous catheter may come out. If either problem happens, it could result in serious breathing or bleeding problems. To minimize the likelihood of any harm, your child's anesthetic care will be directed by experienced anesthesiologists with assistance from nurses and respiratory therapists during the scheduled procedure and transport. You will have an opportunity to discuss these risks with the anesthesiologist.