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
- 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.
- 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?
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
(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
(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.
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.