Got Research Subjects Bill of Rights?

Posted by Joan Rachlin, executive director

While walking through the Beth Israel Deaconess Medical Center (BIDMC) hospital lobby, I caught sight of one of the documents in those ever-present racks of information. Their Research Subjects Bill of Rights was the object of my interest and so I took a look. The relevant section of the document requires that…

Participants have the right to be told:

the purpose of the study
what will happen and how those procedures differ from standard practice
about possible risks and/or side effects
of any benefits that could result
about other possible choices and their advantages/disadvantages
what treatment is offered if complications occur
they can refuse to participate (and change their mind once the study has begun)
they are free from pressure when deciding whether to participate on the study

Participants also have a right to receive a copy of the signed and dated informed consent form. In addition, participants should be aware of what will be expected of them, what they might expect to learn from the study, and if they will receive compensation. I then began to wonder what other local hospitals had to say on the subject, and found that Massachusetts General Hospital (MGH) requires that research subjects have the right…

To be treated in a caring and polite way.
To be told what the study is trying to find out.
To be informed what will happen, and whether any of the procedures, drugs, or devices are different from what would be used in standard medical care.
To be told about possible side effects or discomforts that may occur during the study.
To be told whether to expect any benefit from being in the study and, if so, what the benefit might be.
To be told of other treatment options, and how they might be better or worse than being in the study.
To be told what sort of treatment is available if any medical problems arise.
To be allowed to ask any questions about the study both before agreeing to be involved and during the course of the study.
To be free from pressure when deciding to participate in the study.
To be told about new information learned during the study that might affect the subject’s safety or willingness to continue to take part in the study.
To refuse to be in the study, or to withdraw after the study has started. This decision will not affect the care the subject receives at the hospital.
To receive a copy of the signed consent form.

WOW! I’m impressed by and proud of both these Boston hospitals for developing such clear and accessible statements of subjects’ rights. Speaking of the Boston ties to such manifestos, I’d like to give a shout out to George Annas of the Boston University School of Public Health for having written the original Patients Bill of Rights, from which many, if not most, of these other corollaries have been developed. BIDMC also has a version for patients, and this version includes, at item number 7, You have the right to a full explanation of any research study in which you may be asked to participate. You also have the right to refuse to participate in research. Your refusal will not affect your access to care and BIDMC. BIDMC respects the rights of all individuals who choose to participate (or not participate) in research at BIDMC. So, as they say on Saturday Night Live, “discuss.” All kidding aside, I’d love to hear from the rest of you about some questions I’ve been wondering about since reading these two statements:

What do you think of the content of the BIDMC’s Research Subject Bill of Rights? If you like it, what would you change? If you don’t like it, why not?
What do you think of the content of the MGH’s Research Subject Bill of Rights? Ditto re: the above follow-up questions.
Does your institution have a Subjects’ Bill of Rights? If not, do you think it should?
What are the essential elements that should be included in any such Subjects’ Bill of Rights?
How does an institution go about not only preparing and posting these statements of rights, but how do they ensure their implementation and adherence?

I’d love to get some chatter going about whether these kinds of documents make a difference, as I’m thinking they can and do, but I’m not in the trenches, so thanks for reading and responding!(Photo credit: American Consitution Society of Law and Policy Blog)

stewart laidlaw April 30, 2009 at 9:30 pm

joan
the Experimental Subject’s Bill of Rights (I personally think it should be Subjects’) is enshrined in the Health and Safety Code of the State of California and must be given to all research subjects at the time of consent. At our institution, we attach it to the consent form. The text of the Bill of Rights can be found at Health and Safety Code Section 24170-24179.5. The text reads as follows:
…this list shall include, but not be limited to the subject’s right to:
(a) Be informed of the nature and purpose of the experiment.
(b) Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
(c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
(d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
(e) Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
(f) Be informed of the avenues of medical treatment, if any,available to the subject after the experiment if complications should
arise.
(g) Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
(h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without
prejudice.
(i) Be given a copy of the signed and dated written consent form as provided for by Section 24173 or 24178.
(j) Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any
element of force, fraud, deceit, duress, coercion, or undue influence
on the subject’s decision.

There are some wrinkles – if you have an FWA, you do not need to have the subject sign the form; otherwise, you do, etc.

Stewart Laidlaw

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2 thoughts on “Got Research Subjects Bill of Rights?”

stewart laidlaw April 30, 2009 at 9:30 pm

joan
the Experimental Subject’s Bill of Rights (I personally think it should be Subjects’) is enshrined in the Health and Safety Code of the State of California and must be given to all research subjects at the time of consent. At our institution, we attach it to the consent form. The text of the Bill of Rights can be found at Health and Safety Code Section 24170-24179.5. The text reads as follows:
…this list shall include, but not be limited to the subject’s right to:
(a) Be informed of the nature and purpose of the experiment.
(b) Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
(c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
(d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
(e) Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
(f) Be informed of the avenues of medical treatment, if any,available to the subject after the experiment if complications should
arise.
(g) Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
(h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without
prejudice.
(i) Be given a copy of the signed and dated written consent form as provided for by Section 24173 or 24178.
(j) Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any
element of force, fraud, deceit, duress, coercion, or undue influence
on the subject’s decision.

There are some wrinkles – if you have an FWA, you do not need to have the subject sign the form; otherwise, you do, etc.

Stewart Laidlaw

Reply ↓
Joan Rachlin May 4, 2009 at 12:49 pm

Thanks so much, Stewart! This is important information to know and I am very impressed, and very grateful, to hear that you append this to the consent forms.

Onward toward great protections, and to more HRPPs following your lead re pairing the ESBoR with each consent form.

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2 thoughts on “Got Research Subjects Bill of Rights?”