E-mails 2002 M. Gilsenan

NYC 9/11 Public Portal Document

that are planned or may be performed in the future, and provide assurances about the disclosure of test results to patients and others (e.g., their designated clinician). Fully disclose all aspects of study participation, follow-up, and communication of results to subjects. Explain procedures such as collection of specimens, photography, videography or audiotaping, retrospective or prospective medical record review. Explain anticipated benefits (if any). Explain the costs and any reimbursements of study participation. Explain that study participation will not affect the subject’s rights to receive any other care that he/she was otherwise entitled to at the site. Explain that consent must be fi-eely and volimtarily given, and that persons may refuse or withdraw without penalty. Do not include any exculpatory language in the consent form.

Other languages (specify) None Attach translated consent form if applicable.

Is FDA-regulated product involved? □ No □ Yes IND/IDE number & date: / /

If pending, date requested:____ / / □ Include Investigator Brochure

DOH Involvement Please check all that apply: □ data provision (specify data & sourcefsj:

funding identify mechanism:

subject recruitment explain: DOH staff will assist EPA in notifying and explaining test results to building owners and residents. use of DOH facilities specifyfacility & activity that will take place:

□ staff participation in research activities specify staff& describe activities, including specific consultation responsibilities Nancy Jeffery, Director, Environmental and Occupational Disease Epidemiology, will oversee DOH involvement in this study, including supervision of any DOH staff who participate. DOH’s primary responsibility will be to help interpret the health significance of any COPCs that are detected. n other describe:

S^nature of Principal Investigator: Date: / / I approve the research plan described in this application. Signature of Program Director or Assistant/Associate Commissioner: Date: / /

NYC-WTC_000162370