Personal Genome Project

1) Education: Prospective participants familiarize themselves with all aspects of the PGP, including eligibility, benefits, risks, and study protocols. Individuals make a determination of whether any personal factors exist, such as strict privacy preferences, that may influence their decision to participate.

2) Assessment: An online exam will assess a prospective volunteer's comprehension of concepts relevant to providing informed consent to participate in the PGP. This exam will include concepts such as potential risks of participating, project protocols, and basic genetics. A 'mini-consent' will be affirmed by the volunteer online prior to the exam.

3) Consent: After completion of the exam, invididuals will submit online their consent to participate in this research study.

1) Questionnaires: To create a participant profile, volunteers will be asked to complete online questionnaires that will include topics such as allergies, immunizations, medical history, medications, physical traits and measurements, diet, ancestry, lifestyle, and environmental exposures. Once enrolled, participants will be asked to periodically update and add to this information.

1) Pledge: After the completion of the trait questionnaires, indviduals will be asked to specify the fee amount they pledge to pay if enrolled in this project. The fee to enroll is $1000. Fees are payable after the visit to a medical center, described below. Financial assistance can be requested by those unable to pay the full fee. Enrollment fees are intended to subsidize the costs of genome sequencing and related research activities.

2) Invitation: Individuals selected to continue to the next stage of the enrollment process, will receive an invitation to schedule an appointment to visit a designated medical center.

1) Interview: At the medical center, participants will be interviewed by one or more PGP staff who will verify identity and consent, confirm familiarity with the study protocols, as well as review and confirm trait questionnaire responses.

2) Tissue specimen collection: Volunteers will be asked to submit a tissue sample (blood sample, saliva sample, and/or skin cells from arm or leg). The tissue sample submitted will permit scientists to perform DNA sequencing and other biological measurements. The data generated from these procedures, such as a DNA sequence, will be added to the participant profiles. Tissue samples will be collected by a licensed health care professional appointed by the research study.

1) Pay fees: After the visit to the medical center, individuals will be asked to pay the enrollment fee.

2) Biological analyses: The tissue specimens collected will be prepared for DNA sequencing and other biological analyses. Data generated from these analyses will be added to participant profiles.

1) Default Access: Only the participant him/herself and a small number of researchers who have obtained PGP security clearance will be granted access to participant profiles. The names of all people with access will be approved by the participants in advance. This is the default level of access for all participant profiles.

2) Controlled Access: Participants can opt-in to have their participant profiles accessible to researchers generally, screened via NIH dbGAP or similar mechanisms.

3) Public Access: Participants can opt-in to have their participant profile made available on a publicly accessible website.

1) Safety monitoring: The PGP has a Data Safety Monitoring Board (DSMB) that monitors the impacts of the PGP on enrolled participants. Every three months, participants are required to respond to an email from the DSMB that asks whether any adverse events have occured as a result of participation in this research study.

2) Profile updates: Participants may receive invitations to voluntarily submit additional types of personal information and tissue samples as the study progresses.

3) Project updates: The PGP will keep participants informed about achievements, new initiatives, and other project related activities.