This letter is following up on a conversation or email in which you expressed a possible interest in volunteering for the Personal Genome Proje= ct (PGP) or similar efforts

MIME-Version: 1.0 Content-Location: file:///C:/A9845235/PGP_ques05.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" This letter is following up on a conversation or email in which you expressed a possible interest in volunteering for the Personal Genome Proje= ct (PGP) or similar efforts

This letter is followi= ng up on a conversation or email in which you expressed a possible interest in volunteering for the Personal Genome Project (PGP) or similar efforts. We received HMS-IRB approval for the study and are moving toward recruiting th= ree volunteers by March 2006 and 100 soon thereafter, hopefully guided by your responses b= elow and ongoing conversations with you. See attached consen= t form including risks/benefits (and http://pgen.us

for updates).

If you = and your family are willing, below are some questions which would help us determine if or how PGP data would be made available to qualified researchers. The questions are not meant to represent rigorous sociological research, but ra= ther an informal, practical reality-check on how we might make PGP work, based o= n a non-random sample of people who have already given a great deal of thought = to this problem.

#1. What data would you be willing to have collected privately or publicly? Please= list as many as you want.

(a) Full genome sequence

(b) Gen= ome sequence omitting specific items (please give examples and/or how you think this could be done practically, and how this might change with time).<= /o:p>

(c) Full medical records

(d) Med= ical records omitting specific items

(e) Fac= ial data with/or without past photographs or descriptions of possible cosmetic interferences in the phenotype (potentially useful for morphological geneti= cs)

(f) Non-facial morphometric measures

(g) Transcriptome, proteome & DNA methylation data

(h) Ful= l name (potentially guessable from items above)

#2. What le= vel of security would you be willing to have for your data (private or public)? Pl= ease list all that would be acceptable. <= /span>Since #1= & #2 are interrelated, please feel free to indicate combinations acceptable to you, e.g. [1b & 2c] or [1a-g & 2a].

(a) totally open

(b) Req= uiring an online "click-through" agreement<= /p>

(c) Req= uiring a password given out to legitimate researchers=

(d) Req= uiring IRB approval for each viewing researcher

(e) De-identified data or pools of X subjects. Please state an acceptable X.

#3. What le= vel of impact are you willing to have on your own time?

(a) Giv= e DNA for genome sequencing

(b) Giv= e DNA for sequencing and sign consent forms for access to medical records.

(c) Giv= e blood and fibroblasts for the Coriell cell repository= , for a variety of phenotype assays and give access to medical records.

(d) As = above plus X hours for additional diagnostics (e.g. fMRI). Please estimate X.<= /p>

#4. What wo= uld your family recommend for this project? How can we be assured that they and= you are sufficiently well informed and consent? List all that apply.

(a) No interest

(b) Exa= mine risks of genetic discrimination spill-over from you as subject to them=

(c) Und= ergo ethnographic and/or psychological observation to determine impact of the st= udy (note: this was suggested by an ELSI group, not IRB or PGP).

(d) Def= lect or deal with an additional X hours per month of email/phone contacts due directly or indirectly to the PGP study. Please estimate an acceptable X.

(e) PGP should provide family genetic counseling or other educational services.

#5. Do you = think that it is desirable and practical to provide some sort of (health,life, employment) insurance for you (the subje= ct) and family against genetic discrimination? This could be a fund established= via charitable donations and hence need not be profitable. Would such a fund impact you or yo= ur family's answers to #1-#4? How might it impact the diversity of subjects?= What about joblessness even if insurance is provided? What about how their lives could c= hange based on taunting in their community? What about social impact of = people and who they might want to marry and other things not insurable?=

#6 What risks and benefits to you see for PGP beyond those mentioned on the PGP web page? What additional means would you like to be updated on new data and opinions on possible risks and benefits?

#7. Are you willing to have your views on the above 6 questions shared with other researchers, and if so, at what level of security? Please use the same categories as = in question #2.

Acknowledgments : These questions were developed with input from the HMS-IRB, NHGRI-ELSI, Eric Juengst and Ting Wu. (This is not meant to imply that= they have approved it in its current form).