For my graduate project, I needed to undergo not just training in my specific engineering field, but also through the IRB (Institutional Review Board) in order to ensure that the studies I was conducting with babies would be conducted in a controlled manner, safe, ethical, and not violating any privacy rights of those participating in my research. I was astounded at the level of detail included in my training in order to educate me about what exactly consent means, and how to protect privacy–not because I don’t care about those who are participating in research (actually, the opposite), but because I don’t see the same attention and care being given to those who practice medicine and research in clinics and hospitals today. It saddens me because in my class, there was a protected class mentioned: children and pregnant women. It was stated that these people in particular require special attention and protection due to their vulnerable state.
Consent requirements are as follows:
Informed consent is not a “one and done” process, you should view informed consent as an ongoing process throughout the study. Individuals should always be welcome to ask further questions, reconsider participation, retract certain data, or withdraw their data after the study takes place (realistically, however, if someone completes an online survey that collects no contact information or direct identifiers, you may be unable to screen out one individual’s data.
Your consent materials must be clear and understandable to potential subjects, which means you should use non-technical, straightforward language with vocabulary around the sixth to eighth grade reading level. Specific regulations (45 CFR 46) require that you present key information to facilitate understanding and ensure consent includes sufficient detail to assist an individual with making a decision regarding participation.
If necessary, translate consent documents into the intended population’s language or include an interpreter on your research team (there may be specific regulatory and institutional requirements when recruiting a non-English speaking population, so consult with your IRB for guidance).
A basic informed consent form will include the following information (as required by 45 CFR 46) and any other specific institutional requirements.
Include contact information for you, your faculty advisor, and your IRB or compliance office.
Information explaining that the subject is being asked to participate in research, including the purpose of the study, how long the study will last, and a detailed description of the tasks involved (including any interventions).
Risks or discomforts the participant may experience.
Potential benefits to subjects or others.
The degree of confidentiality a subject can reasonably expect, which includes who will have access to the data, where and how you will store data, how you will report data/results (for example, in aggregate or using pseudonyms), and how you will use results (such as in reports, publications, or presentations).
A statement that the individual’s participation is voluntary, refusal to participate will not negatively impact the individual, and the individual may stop the study at any time without consequences.
Any appropriate alternative treatments that may be advantageous to the subject instead of the research.
AND it is highlighted that participants of research need to be treated as autonomous agents. This means you cannot make decisions for them or make them feel like they have no control over what they can and cannot do, otherwise it promotes the way Hitler made his captives feel in Nuremberg. In fact, this concept is called the Nuremberg Code.
Yet, I recall when I was pregnant, nobody cared about explaining anything to me regarding the tests and screens they wanted to perform on my body. The first doctor I went to for OB services wouldn’t answer my questions, and his nurse wouldn’t even look at me, just treated me like I was another number chugging out insurance money for their clinic.
“Here’s a gown, get undressed so we can perform the tests.”
Um, excuse me. Hello to you, too. What’s your name? What tests? What are the benefits and risks to me and my baby? And what if I decide to decline?
I was not given the opportunity to decline, because I was not asked for consent. I think it was implied that if I undressed and got on the examining table, then I was giving consent. In fact, this seems to be the practice in most OB/GYN clinics, but it is unfair. The women who are going to these doctors are going for sensitive matters. They likely have questions and by being treated in this way, they are being given the impression that yes, you have no other choice but to do what you are told (since it’s not like they word it in the form of a question).
And let me let you in on a secret, your questions are valid! And not all pregnancy screens are required, but the doctors and clinics are making money off of them, so if you’re not questioning them or stopping them, they’re going to keep doing them on you. I went through the list of tests that they had planned for me and my baby (even before he was born) and told them which ones I DECLINED. That’s right, you can decline. I did my own research and told them I didn’t want the STD test, I don’t have any. Thank you very much. Money saved there. I didn’t want the eye ointment in my newborn’s eyes, or any vaccines as he entered the earth either. That’s way too harsh. More money saved and less trauma for my little chick.
Did you know the gestational diabetes screen they perform on you does more harm than good? It usually produces an inaccurate result, and the amount of sugar you intake (100 grams) during that screen is not good for your baby…at all. So what are the pros versus cons? Your doctor has the responsibility of explaining it to you, yet if you ask, they’ll likely say that it’s routine. If you push for more details, a not-so-great doctor will make you feel guilty for hesitating to follow his/her orders, but might throw a pamphlet at you with generic information (it still won’t go over the fact that this test has risks, though). A good doctor will go into detail about what he/she knows about this screen, however, and try to not only make you feel comfortable about the screen but allow you to decline it. It sounds silly to say ALLOW. But every doctor should allow you to skip whatever tests you want, it’s your body, and your baby. They don’t control you, and when you feel differently, or guilty, just remember. You’re the ones paying them for a service (the glucose test is about $75 according to MDSave but could run higher if you don’t have insurance), and just like you would shop around for the best mechanic or school for your child, you wouldn’t feel guilty asking questions to ensure you’ve made the right decision so treat your pregnancy the same.
Honestly, even if you have gestational diabetes, they’re just going to tell you to change your diet. There’s no medicine they can give you for it. I had it during my first pregnancy and they didn’t diagnose me with it. The test has a high likelihood of producing a false positive in 15%-20% of women. Things like stress can affect it, too!
If a mechanic told you there was a “routine” test to be done on your engine that cost $350, I doubt you would just say, “go ahead”. And this doesn’t even involve your body!
Therefore, I wonder why women feel so guilty standing up for themselves and being confident that they’re smart to ask questions and be sure that the tests being done on them and their babies are safe and the best practice. Just because something is “routine” doesn’t mean there isn’t a better option. Maybe the doctor is lazy and doesn’t want to do the extra work of checking your blood work or something else in order to determine what it is that you’re looking for. I once asked for an early ultrasound to ensure I wouldn’t have a miscarriage, and the doctor I was with declined stating it was “unnecessary”. I said I didn’t care. It was necessary to me for peace of mind. And they don’t care to charge me for “unnecessary” tests like pap smears and STD tests (which I also decline), so if I’m paying for everything they do, then I can ask for tailored services.
I left that doctor and found a doctor that was right for me. She understood my need to ask questions and get detailed information. When she wasn’t sure of something, she did research (as a good doctor should do). I told her what I would and wouldn’t be comfortable with during my child’s birth (i.e. I wouldn’t give consent to using vacuums if my baby’s head was to get stuck) and she respected my wishes without getting upset.
If your doctor doesn’t understand what consent means, and doesn’t let you say no or ask questions, then you’re at the wrong doctor. Students are being held to strict requirements for research, but unfortunately, after doctors are granted their medical licenses, no one babysits them to ensure they stick to ethical standards and treat their patients with the respect they deserve.
Even if you give consent to something, you should be allowed to speak up and say you want them to stop in the middle of a procedure. Ask when you’re unclear about something. Your privacy matters, too. There are women who have stated they were undergoing breast exams as a male doctor interrupted to chat with her male doctor about a sports game. She felt embarrassed because she was exposed but didn’t know what to say. If you’re in a teaching school, maybe there are students watching your birth, but you don’t know how to express that this was not how you envisioned your baby being born or that you would like some privacy. Let your nurse know and have her deal with it.
No one is perfect and lots of laws and systems are broken.
But you can stand up for yourself. You’re pregnant but you still have a voice. There are women being held down on operating tables and forced to have C-sections, pap-smears and other procedures against their wills because their husbands or court orders have allowed it, and this is just unacceptable. Consent is so important, and it makes me wonder why people claim to protect women against rape yet aren’t looking at how professionals are taking advantage of women everyday.
Next time you speak to a pregnant woman, ask her about her experience and see if you can encourage her to be brave. Remind her she is autonomous and that “no” means no in every aspect of her life, and she should feel comfortable not just in her bedroom, but in her place of work, at her doctor’s office, and elsewhere. It starts with us.