Thursday, January 28, 2010

Informed Consent & Refusal

Childbirth Connection is a wonderful organization that is dedicated to improving maternity care. Here is what they have to say about informed consent & refusal:

Who is responsible for making informed maternity decisions?

When pregnant, giving birth, and after birth, women are responsible for making informed

decisions for themselves and on behalf of their babies. They have the legal right to give

"informed consent" or "informed refusal." Most women report a high degree of interest in

knowing what a proposed maternity intervention would involve, alternatives (including no

action), and potential benefits and harms of the different choices. Maternity professionals are responsible for providing scientifically supported care and for carrying out established legal processes for informed consent. Legally, "patient viewpoint standards" are in effect in many or most states. This means that clinicians must tell those in their care about the possible benefits and harms that a reasonable person in that situation would want to know to make an informed decision. Much time and effort are required to meet these legal and ethical standards for informed consent. Women need full and accurate information about labor and birth decision points and interventions well before labor to be able to pursue the care of their choice and make informed decisions around the time of birth.

Why is women's involvement in maternity care decisions important?

The decisions women make and the maternity care they receive can have lasting effects on

the health and well-being of their baby, themselves, and their family. It is always important to understand whether there is a clear, well-supported rationale for any procedure, drug, test or treatment that is being considered. In many care settings, some practices are used freely and even routinely, whether or not the mother or baby have shown a clear need. Although these practices may be of value to women or babies in certain situations, they may be unnecessary for most. They may be disruptive, be uncomfortable, cause more serious side effects, and lead to the use of other interventions. For these reasons, interventions should not be used routinely or unnecessarily.

What are important factors for informed maternity decision making?

For a woman, making informed decisions means learning and thinking about the best

information available on maternity care, and then deciding what's right for herself and her

baby. Key questions include:

• What are the possible choices?

• What does the best available research tell us about beneficial and harmful effects of each of these choices?

• What are her own needs and preferences and those of her partner (if she has one)?

• What choices are available and supported in her care setting and through her caregivers?

• If she wants an option that will not or may not be available, would she consider switching to a care setting or caregiver that does offer the preferred care? It is not possible to know ahead of time exactly what a woman's labor experience will be like. Being as informed as possible in advance can help women deal wisely with any new decisions that may arise at the time. It is important for a woman to learn about options, get answers to her questions and think about her preferences well before labor begins. It is also important that her partner or other support people are aware of her wishes and prepared to speak on her behalf if the need arises.

What does it mean to give "informed consent?"

Informed consent is not a form or a signature. It is a process between a woman and her

caregivers to help her decide what will and will not be done to her and her body. In the case of maternity care, informed consent also gives a woman the authority to decide about care that affects her baby. The purpose of informed consent is to respect her right to self-determination. It empowers her with the authority to decide what options are in her best interest and the best interest of her baby. Her rights to autonomy, to the truth (as best as it can be known at the time), and to keep her and her children safe and free of harm are very basic human rights.

What are women's legal rights to "Informed Consent" and "Informed Refusal?"

Whenever a medical procedure, drug, test, or other treatment is offered to a woman, she has the legal right to "informed consent." This means that her doctor, midwife or nurse is

responsible for explaining:

• why this type of care is being offered

• what it would involve

• the harms and benefits that are associated with this type of care

• alternatives to this care, and their respective harms and benefits, including the possibility of doing nothing and simply waiting longer.

A woman has a right to clear and full explanations about her care and answers to any and all

questions about her care. She also has the right to request and receive a copy of her medical

records and to get a second opinion. Then, by law, she has the right to decide whether to accept the care that is offered. If she disagrees with her caregiver and decides not to accept care that is offered, she has a right to this "informed refusal." And, even if she signed a form agreeing to a particular type of care, she has the right to change her mind. Although these are well-established legal rights, they have been challenged in a few recent cases. It can be difficult to carry out the informed consent process in busy health care settings. Yet, a woman and her caregiver should set aside the time to discuss these issues in advance whenever possible, and again when it is time to make a decision. It is crucial that women do not learn about procedures and options for the first time while in labor and facing important decisions. At that time, it may be too late to get all questions answered, weigh options, and pursue specific preferences.

What are some tips to help women explore these issues with their doctor or midwife?

Women can make a list of questions before each visit, and jot down the answers. They may

wish to bring their partner or someone else who is close along to listen to what is said. This is not the time to be shy; nothing is off limits.

While talking with caregivers, women can say:

• I don't understand.

• Please explain this to me.

• What could happen to me or my baby if I do that? Or if I don't?

• What are my other options?

• Please show me the research to support what you're recommending.

• Where can I get more information?

• I have some information I'd like to share with you.

• I'm uncomfortable with what you are recommending.

• I'm not ready to make a decision yet.

• I'm thinking about getting a second opinion.

Any question that a woman has is worth asking. When answers are not clear, women should

ask again until they understand.

What happens if a woman and her caregiver disagree?

Caregivers have rights, too. They have the right to agree or disagree to provide care that a

woman may request. For example, if a woman requests a cesarean and has no medical need

for this procedure, her caregiver has the right to refuse to do the surgery. Increasingly, fear of lawsuits is leading caregivers and hospitals to refuse to provide some types of care that would be a good and reasonable choice for many women, such as vaginal birth after cesarean (VBAC). Forcing healthy pregnant women with a previous cesarean to have major surgery against their wishes seriously compromises the quality of maternity care. Major liability system reforms are needed to improve this situation.

These issues speak to how important it is to have a good collaborative relationship that

includes open communication, mutual respect, and shared points of view. A woman who takes care to find a doctor or midwife who respects her needs, values and goals can help avoid conflict down the road.

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