Mitchellmemo37

The last several decades have witnessed an amazingly rapid advancement in the domain of biology, biotechnology, and biomedicine. In particular, the fields of reproductive technologies, genetic screening, genetic engineering, organ transplantation, xeno transplantation, and stem cell research have all grown at such a brisk rate much of the rest of the society that the science and technology is embedded in often find it difficult to keep up. One perpetually hears of the bewildered politician unsure of how to react to the latest biotechnology he or she never even knew was being created, the confused regulatory agency uncertain if such and such bioscience is under their purview, or the religious leader confounded with the ambiguities of whether the latest biological breakthrough is acceptable to his or her preferred deity. All the while, many scientists find themselves as the simultaneous creators and adjudicators to some of the most complex and intractable questions imaginable, like that of life itself. The result of all of this has been the growing confusion and jumbling of norms, ethics, scientific practices, and regulatory procedures. Moreover, given the rate of bioscientific and biotechnical advances, analogous confusions will no doubt continue, perhaps at an accelerated pace. Understanding how these confusions work and how scientists, regulators, and the public operate within and get through such states (i.e. reassemble or create a new norm) is vital for the coming century. Taking one example amongst the possible myriad, this project seeks to study and analyze the current and ongoing situation around human-animal embryonic chimera research[1] in the U.K. It is an exemplary biotechnology that demonstrates how much of contemporary biotechnology forces portions of society (or perhaps all of society) to confront the fact that many old norms, categorizations, and ways of doing things simply no longer hold up; norms blur into the abnormal and it is often difficult to tell them apart. For instance in chimera research, the production of potentially lifesaving medicines (the norm) extends into the creation of animal-human mixtures (the abnormal). The primary purpose of this project is to understand how norms (of science, ethics and policy) are reconfigured after entering such a state.
 * Summary **

1. Title of Proposal: “Chimera Research and the Cultural, Political and Scientific Imaginations of the Future.”
 * RESPONSE TO IRB QUESTIONS **

2. Principal Investigator: Ross B. Mitchell

3. Address: Sage

4. Phone: 518-555-5555

5. N/A

6. Department: Science and Technology Studies

7. Objective: This anthropological and ethnographic study will document and analyze the emerging field of chimeric stem cell research, conducting in-depth ethnographic interviews to understand new directions in scientific research ethics.

8. Methods: Approximately 60 in-depth interviews (approximately two hours in length) with stem cell researchers, regulators, and interest groups will be conducted for this study. Interview subjects will be recruited through email messages that describe the aims and methods of the project, and include a copy of the project’s informed consent form. A preliminary interview guide is included below.

9. Effects on the subjects: There will be minimal physical effects on the subjects because they will be interviewed.

10. Measures to minimize risk: All interviews will be voluntary. Interviewees will be given the opportunity to be anonymous, to stop the interview at any point, or to retract the interview or parts of it before publication. The tape of the interview will be stored on the computers of Ross Mitchell as password protected (128-bit) encrypted files, and will not be shared with anyone. All hard copies of the transcript will be stored in the offices of Ross Mitchell, which are locked when he is not present. Only Ross Mitchell will have access to both electronic and hard copies of transcribed interviews. All copies of the interview (recorded and transcribed) will be destroyed at any time on the request of the interviewee.

This is detailed in the attached informed consent form for interviews

11. Likelihood of harm: Minimal.

12. Documentation of risks: None.

13. Benefits to participants: Participants in this study will directly and indirectly benefit from development of a historical record and cultural analysis of the field of exposure assessment. Results of the study will be presented to exposure assessment researchers, and also to decision-makers responsible for funding and using exposure assessment research.

14. Alternative Method not Using Human Subjects: None possible.

15. Qualifications of Researchers: Ross Mitchell has is a PhD student in the department of science and technology studies. Ross Mitchell conducts interviews in accordance with the code of research ethics established (and recently updated) by the American Anthropological Association.

16. Recruiting of subjects: Interview subjects will be contacted directly, informed of the purposes of the interview, and given the opportunity to refuse the interview.

17. Confidentiality: The participants will be given the opportunity to define the extent to which their names will be associated with any (or all) statement(s) during the interview, and will be given the right to retract any statement at any time prior to publication of research results. Any statements that participants designate as “off the record” will not be attributed to the participant, nor used in a way that would link their statement to said participant. As is codified in the informed Consent Form, I will use any such comments only as background information, and will not quote them in either an attributed or unattributed fashion in any of my future work.

18. Specimen of Consent Form: Please see attached “Informed Consent Form.”

19. Preliminary Interview Guide is also attached below.

Contact information for Rensselaer Polytechnic Institute Review Board: Chair, Institutional Review Board, Rensselaer Polytechnic Institute, CII 7015, 110 8th Street, Troy, NY 12180 This interview with is being conducted as part of an anthropological study of the exposure assessment research community. The research will result in public talks, articles, and a book. The interview will be recorded on tape, with the following conditions: 1. Your participation in this interview is voluntary. You may terminate the interview at any time during our conversation. The interview will last approximately two hours. 2. You may ask that the tape be turned off at any time during this interview, and I will turn the tape off. 3. You may designate any comments you make on the tape as “off the record.” You may also designate comments as “off the record” retrospectively, either at a later point in the interview or in the process of approving the transcript. I promise to use such comments only as background information, and will not quote them in either an attributed or unattributed fashion in any of my future work. 4. I will transcribe the tape in part or in full. I will submit any such full or partial transcript to you for your approval. You will be free to edit, clarify, amend, or delete any part of the transcript before returning it to me, having made a copy of the transcript and any changes you make to it for your own files. 5. I will be free to quote from this approved transcript, and only this approved transcript, in my future work. The tape itself will not be made public in any fashion, and can also be destroyed if you so request. The transcript of the interview will not be made public unless you explicitly approve a request to do so. 6. The tape of the interview will be stored on the computers of Kim Fortun as password protected (128-bit) encrypted files, and will not be shared with anyone except for the person hired to transcribe the interview. The transcriber has been instructed to consider all transcripts strictly confidential, and to destroy all copies of the interview once the transcription has been transmitted to Kim Fortun. Once as a digital text file, the transcript will be stored on the computers of Kim Fortun, again with password protection and encryption. All hard copies of the transcript will be stored in the offices of either Kim Fortun, which are locked when she is not present. Only Kim Fortun will have access to both electronic and hard copies of transcribed interviews. All copies of the interview (recorded and transcribed) will be destroyed at any time on the request of the interviewee. 7. You have the right to remain anonymous, and can do so by initializing here: _. If you do not choose to remain anonymous, in quoting from the approved transcript in my future work, I may attribute remarks directly to you, but will not necessarily do so. 8. If you have any additional conditions that you would like to add, write them here and they will be considered part of this agreement: Additional Conditions: Finally, if for any reason you change your mind about this interview or any of these conditions in the future, I promise to respect any request that you make to me. I will not be able to retract anything that is already in print or in press based on the approved transcript, but I will honor any future request to change any of the terms of this agreement, up to and including complete retraction of the interview and permission to quote from it.
 * INFORMED CONSENT FORM**
 * Chimera Research and the Cultural, Political and Scientific Imaginations of the Future.**
 * Ross Mitchell, Department of Science and Technology Studies**
 * Rensselaer Polytechnic Institute / Troy, NY 12180 / mitchr4@rpi.edu**

INTERVIEWER date:

INTERVIEWEE address _ _ phone _ email _


 * Aim 1. How is human-animal chimera research enabling the construction of new imaginaries in norms/ethics/policy? ||

-How do you juggle the “hopes” and the “horrors” of your research? || -How do you maintain or reconstruct new boundaries? || -How has your work altered what is considered possible in science? || -What type of a world do various publics imagine such research will ultimately lead to? ||
 * · How do scientists view the work they are doing? || -How do you think about your own work?
 * · How are meaning systems reconstructed after a conceptual breakdown? || -How do you deal with ambiguities engendered by research?
 * · How are new imaginaries interacting with policy, regulations, norms, ethics and economics? || -How has your/their work altered policy and regulatory regimes?
 * · How does the public react to research in conflict with old normative and conceptual schemes? || -What techniques do interest groups use to express their concerns?


 * Aim 2. How does a field and researchers in that field navigate the “cutting edge?” ||

-How do you view/incorporate the public’s view of your work? || -What other than technology led to/allowed you to proceed with your current research? || -What avenues does being on the “cutting edge” open up? || -What kind of a world do your imagine your research is contributing to? ||
 * · How do scientists interact with the public? || -How do you view the public?
 * · What factors have led to the development of such a research track? || -What factors have influenced your choice of particular technologies and techniques for your research?
 * · How are scientists constrained and enabled by being in such a space? || -What limits are placed on your work?
 * · How do scientists imagine the future of the field and their place in it? || -Where do you believe your research will ultimately lead?