Consent

Investigators are responsible to discuss the research with subjects, and to document the subjects’ consent to participate. The consent process must be adapted to the decision-making needs of the subject.  Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process.

• Federal regulations describe the required elements of consent.

  1. A statement that the study involves research, an explanation of the purposes and the expected duration of the subject’s participation, and a description of the  procedures, noting any procedures which are experimental;
  2. A description of reasonably foreseeable risks or discomforts;
  3. A description of benefits to the subject or others that may reasonably be expected;
  4. Disclosure of appropriate alternative procedures or courses of treatment;
  5. A statement of the degree to which confidentiality of records identifying the subject will be maintained;
  6. For studies involving more than minimal risk, a description of any compensation that will be provided, and of medical treatments that are available in case of injury;
  7. Who to contact for answers to questions about the research, about research subjects’ rights, and about research-related injury;
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled

• There are additional elements that must be included if appropriate.

  1. A statement that there may be unforeseeable risks to the subject (or the embryo or fetus) if the subject is or may be pregnant;
  2. Anticipated circumstances under which the subject’s participation may be terminated without the subject’s consent;
  3. Additional costs that may accrue to the subject as a result of participation;
  4. Consequences of early withdrawal from the research, and procedures for orderly termination of participation in such an event;
  5. A statement that any significant new findings that may relate to the subject’s willingness to continue will be provided;
  6. The approximate number of subjects involved in the study.

• The requirement to obtain informed consent can be altered or waived if all of the following conditions pertain:

  1. The research involves no more than minimal risk to subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. When appropriate, subjects will be provided with additional pertinent information after participation.

Anti-Depressants

Increased risk of suicidality in children and young adults 

-In line with FDA’s requirement that manufacturers of all antidepressant medications update the black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, to include young adults ages 18 to 24 during initial treatment (generally the first one to two months), the following language is suggested for consent forms in studies in which antidepressant medications will be given:

-The FDA has warned that antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults when the medicine is first started. You should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings, especially when an antidepressant medicine is first started or when the dose is changed. Call your doctor right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Keep all scheduled follow-up appointment with your doctor. Call your doctor between visits if you have any concerns about symptoms. Do not stop taking your antidepressant medicines without consulting your doctor. 

Increased risk of fractures in adults over the age of 50 who are taking SSRIs:

-A study by J. Brent Richards, et al, in the January 22, 2007 issue of Archives of Internal Medicine, and other recent studies, have demonstrated a likely association of SSRIs with increased fragility fractures in elderly adults. The Board determined that this represents a significant new finding, which may relate to willingness of participants to continue in a research study, and must be provided to study participants. (45CFR46.116b)(5). Some suggested wording is:

-Recent studies of depression in older men and women show that there may be a connection between the use of the antidepressants of the kind given in this study, a risk of bone fractures, and a decrease in bone density (loss of “bone strength”) at the hip and spine in men and women. You may wish to discuss this information with the study doctor to see if or how it relates to your use of the study medication.

Other side effects of antidepressant medications:

-Other risks and side effects must also be included. These might include anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania (unusual energy, speaking and thinking faster than usual, feeling more powerful unrelated to the situation or the way you usually feel), mania (racing thoughts, speaking in a fast and pressured way, not needing to sleep, overspending, showing more sexual interest than usual).

  1. PAXIL Warning

     

    Women who take Paroxetine (Paxil) during the first 3 months of pregnancy or who become pregnant while taking Paxil are at greater risk of having a baby born with hearing defects.

  2. FDA SAFETY COMMUNICATION RE: HIGH DOSES OF CITALOPRAM (CELEXA)

     

    FDA has clarified dosing recommendations for the antidepressant Celexa (citalopram).Because of the potential risk of abnormal heart rhythms at higher doses, Celexa should not be used at doses greater than 40 mg/day in most patients, and no greater than 20 mg/day for patients over the age of 60.  (See attached)

Consent

Investigators are responsible to discuss the research with subjects, and to document the subjects'€™ consent to participate. The consent process must be adapted to the decision-making needs of the subject.  Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process.

• Federal regulations describe the required elements of consent.

  1. A statement that the study involves research, an explanation of the purposes and the expected duration of the subject's participation, and a description of the  procedures, noting any procedures which are experimental;
  2. A description of reasonably foreseeable risks or discomforts;
  3. A description of benefits to the subject or others that may reasonably be expected;
  4. Disclosure of appropriate alternative procedures or courses of treatment;
  5. A statement of the degree to which confidentiality of records identifying the subject will be maintained;
  6. For studies involving more than minimal risk, a description of any compensation that will be provided, and of medical treatments that are available in case of injury;
  7. Who to contact for answers to questions about the research, about research subjects' rights, and about research-related injury;
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled

• There are additional elements that must be included if appropriate.

  1. A statement that there may be unforeseeable risks to the subject (or the embryo or fetus) if the subject is or may be pregnant;
  2. Anticipated circumstances under which the subject's participation may be terminated without the subject's consent;
  3. Additional costs that may accrue to the subject as a result of participation;
  4. Consequences of early withdrawal from the research, and procedures for orderly termination of participation in such an event;
  5. A statement that any significant new findings that may relate to the subject's willingness to continue will be provided;
  6. The approximate number of subjects involved in the study.

• The requirement to obtain informed consent can be altered or waived if all of the following conditions pertain:

  1. The research involves no more than minimal risk to subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. When appropriate, subjects will be provided with additional pertinent information after participation.

Anti-Depressants

Increased risk of suicidality in children and young adults

-In line with FDA's requirement that manufacturers of all antidepressant medications update the black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, to include young adults ages 18 to 24 during initial treatment (generally the first one to two months), the following language is suggested for consent forms in studies in which antidepressant medications will be given:

-The FDA has warned that antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults when the medicine is first started. You should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings, especially when an antidepressant medicine is first started or when the dose is changed. Call your doctor right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Keep all scheduled follow-up appointment with your doctor. Call your doctor between visits if you have any concerns about symptoms. Do not stop taking your antidepressant medicines without consulting your doctor. 

Increased risk of fractures in adults over the age of 50 who are taking SSRIs:

-A study by J. Brent Richards, et al, in the January 22, 2007 issue of Archives of Internal Medicine, and other recent studies, have demonstrated a likely association of SSRIs with increased fragility fractures in elderly adults. The Board determined that this represents a significant new finding, which may relate to willingness of participants to continue in a research study, and must be provided to study participants. (45CFR46.116b)(5). Some suggested wording is:

-Recent studies of depression in older men and women show that there may be a connection between the use of the antidepressants of the kind given in this study, a risk of bone fractures, and a decrease in bone density (loss of bone strength) at the hip and spine in men and women. You may wish to discuss this information with the study doctor to see if or how it relates to your use of the study medication.

Other side effects of antidepressant medications:

-Other risks and side effects must also be included. These might include anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania (unusual energy, speaking and thinking faster than usual, feeling more powerful unrelated to the situation or the way you usually feel), mania (racing thoughts, speaking in a fast and pressured way, not needing to sleep, overspending, showing more sexual interest than usual).

  1. PAXIL Warning

     

    Women who take Paroxetine (Paxil) during the first 3 months of pregnancy or who become pregnant while taking Paxil are at greater risk of having a baby born with hearing defects.

  2. FDA SAFETY COMMUNICATION RE: HIGH DOSES OF CITALOPRAM (CELEXA)

     

    FDA has clarified dosing recommendations for the antidepressant Celexa (citalopram).Because of the potential risk of abnormal heart rhythms at higher doses, Celexa should not be used at doses greater than 40 mg/day in most patients, and no greater than 20 mg/day for patients over the age of 60.  (See attached)