The Rest of ASBH

And here are more programs from the recent conference of the American Society for Bioethics and Humanities. And may I say, Buffy the Vampire Slayer came up in one of the sessions!

• Made vulnerable: notes of privilege; or how when you say their name, the bodies go missing
• Assessing public attitudes about the ethics of research on medical practice
• Beneath the covers: film, philosophy and sex
• Moral sources for collaborative, practice-based ethics: a transformation for education and practice
• Theory confirmation, risk and hermeneutics in the early phases of medical research
• Shared vulnerabilities in research
• Guinea pigs for peace: why American World War II conscientious objectors volunteered as research subjects
• Fiction and bioethics: from speculation to practice 
• My donor taught me: reflections from anatomy lab
• Building research integrity and capacity: professional development for research support staff
• Ethics of authorship in interprofessional team-based research
• Big brother is watching? The ethics of electronic adherence monitoring- an interdisciplinary outlook
• Migration and health: opportunities and challenges from the bioethics perspective
• Industry-academy relations: ethical and policy concerns
• Whole genome sequencing: the devil in the DNA
• Ethics in the CTSA program: past, present and a changing future
• Understanding patients’ views on consent for research enrollment in the setting of acute cardiac illness
• Exploring ethics rationales for patient engagement in research
• Medical researchers’ ancillary care obligations: a relationship-based approach
• How to write an exam in bioethics

ASBH Annual Conference 2014

Later this week I will be attending the annual conference of the American Society for Bioethics and Humanities. This is the nation’s largest bioethics conference, and it is always highly entertaining and educational. It makes me consider issues from new perspectives and it shows the full gamut of bioethics scholarship across the country. It features some of the world’s leading ethicists and philosophers, and it also includes many sessions where people working in the field present their research. There are preconference workshops, plenary sessions, paper sessions and affinity group meetings. The affinity groups are groups who gather around common interests. For example, there is an affinity group on rural bioethics, one on Jewish bioethics, another on sexuality and gender identity, one on neuroethics, and so on. These are less formal meetings that occur over meal hours, where people can discuss common interests. I usually try to attend the affinity group on research, and then on whatever hits my fancy at the time.

Below is a list of the general sessions, which will give you an overview of the scope of the conference.

• Articulating the Goals and Assessing the Impact of Bioethics Projects: A Report from the ABPD Working Group

• Made Vulnerable: Notes on Privilege; or, How When You Say Their Names, the Bodies Go Missing

• Moral Sources for Collaborative, Practice-Based Ethics: A Transformation for Education and Practice

• Sanctity of Life, by L. J. Schneiderman: A Staged Reading

• Collaborative Solutions to Challenges in Health Care and Education: A Forum Theatre Workshop

• Bioethics Literacy Across the Lifespan

• Migration and Health: Opportunities and Challenges from the Bioethics Perspective

• A Global Perspective on Women’s Rights to Health and Safety: Progress or Regress?

• From Clinical to Community Sequencing: Emerging Ethical, Legal, and Social Issues in Genomics

We are off at the Davenport campus next week, so I will post upon my return.

The Common Rule: General requirements for Informed Consent

I know that a good number of us have been developing and conducting research in our educational setting. And there are times when we will need to consider developing a consent document; however, not all of us have experience in writing one. Federal law actually stipulates what must be in a consent document, and rather than me summarizing those elements for you, I thought I would simply provide you the specific language, from 45CFR46 (46.116)(1).

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

 (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:

 (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

 (2) A description of any reasonably foreseeable risks or discomforts to the subject;

 (3) A description of any benefits to the subject or to others which may reasonably be expected from the research;

 (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

 (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

 (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

 (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

 (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

 (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

 (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

 (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

 (3) Any additional costs to the subject that may result from participation in the research;

 (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

 (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and

 (6) The approximate number of subjects involved in the study.

 (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

 (1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

 (2) The research could not practicably be carried out without the waiver or alteration.

 (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

 (1) The research involves no more than minimal risk to the subjects;

 (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

 (3) The research could not practicably be carried out without the waiver or alteration; and

 (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

 (e) The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

 (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.

References

1.       http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html, accessed October 3, 2014