1. Comply with, the NSF regulation entitled, ⌠Protection of Human Subjects�¡ [45 CFR 690]  for those projects funded with funds originating from U.S. Government sources; or

2. Comply with the Declaration of Helsinki, the Belmont Report, the International Conference on Harmonization (ICH) guidelines, or the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects for projects funded with private funds or funds from a governmental entity that has not adopted the Common Rule, unless more specific human subjects protections are required by a PO's Federal-wide Assurance.

1. As a condition precedent to any funding by CRDF, Principal Organization(s) and Principal Investigator(s) must each ensure that the rights and welfare of any human subjects involved in research, development and related activities supported by the Award are protected.

2. CRDF provides monitors, audits and/or reviews the activities of the POs and PI/PDs related to human subjects protections as a means of providing oversight and stewardship of research funds. No party to this Agreement intends such actions to indicate that CRDF is in any way responsible for the conduct of the research or for complying with the human subjects protection requirements set forth herein.

⌠Human subject  is defined as ⌠a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information. [45 CFR  690.102(f)]

⌠Research is defined as systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of applying the regulation even if they are supported by a grant that might have as its overall purpose an activity that is not primarily research. For example, some demonstration, training, and service programs may include research activities. [45 CFR  690.102(d)].

⌠Serious Adverse Event  may be defined as any adverse experience that results in any of the following outcomes: death; life-threatening adverse drug/device/product experience; inpatient hospitalization; prolongation of existing hospitalization; persistent or significant disability / incapacity; and/or congenital anomaly or birth defect.

⌠Unanticipated problems involving risk to human subjects may be defined as events unexplained or unexpected in the context of the original research proposal and the scientific literature at the time the protocol was first submitted to the Institutional Review Board (IRB) / Independent Ethics Committee (IEC).

The PO and PI/PD each certifies that:

1. It has obtained IRB or IEC approval of the research (or a determination that written approval is not required, e.g., exempt research) from an IRB/IEC registered with the US Office of Human Research Protections (OHRP);

2. It has obtained the required approval(s) (or a determination that written approval is not required) from the applicable governmental office(s) for the research, including but not limited to the filing of the required applications related to investigational new drugs or investigational devices;

3. It has a Federal-wide Assurance (FWA) on file with OHRP, and it will comply with the FWA throughout the term of the Project Agreement, which represents a public commitment to comply with the human subjects protections standards of the Belmont Report and the Common Rule;

4. It will conduct the research in accordance with the NSF regulation entitled, Protection of Human Subjects [45 CFR 690 et seq.];

5. It has policies and procedures in place to address and report possible scientific misconduct in conformance with the laws and regulations of the applicable governmental office(s);

6. It has a conflict of interest policy whereby POs, PI/PDs and Project Participant(s) are required to report potential conflicts of interest as may be required to enable these interests to be considered by the IRB/IEC in its review and approval of the research;

7. POs(s) and PI/PDs have furnished adequate training regarding human subjects protections to their employees, agents, subcontractors, and representatives.

1. FWA/IRB/IEC: POs will each provide CRDF with its FWA number, and its IRB/IEC registration number prior to the initiation of the research.

2. Evidence of IRB/IEC Approval: POs will each provide CRDF with written evidence of review and approval of the research (or a determination that written approval is not required) by a qualified IRB/IEC prior to the initiation of the research, and on an on-going basis, which shall be at least annually.

3. Compliance With Approved Proposal/Protocol: POs and PI/PDs will each not deviate from or amend the proposal that was approved by the IRB/IEC without prior written notification to CRDF and approval by the IRB/IEC, except where necessary to protect the safety, rights or welfare of a participant. In the event of modification of the proposal for the welfare of subjects, the POs and PI/PDs will each immediately notify the appropriate IRB/IEC, with a copy to CRDF, of the action taken or to be taken, and how such action is/was in the best interest of the participant.

4. Informed Consent: POs and PI/PDs will each use the IRB/IEC approved version of the informed consent that complies with all applicable provisions of 45 CFR Part 690, including additional safeguards for research involving vulnerable populations (45 CFR  690.111(b)) and obtain documented voluntary informed consent from each participant prior to enrolling the subject in the research.

5. Adequate Qualifications: POs and PI/PDs will each ensure that it and its employees, agents, subcontractors, and representatives are qualified by education, training and experience to conduct and/or participate in the research.

6. Adequate Resources: POs and PI/PDs will each ensure that there are adequate resources, including qualified staff and facilities, for the duration for the trial to conduct the trial properly and safely and in conformance with governing laws and/or regulations.

7. Confidentiality: POs and PI/PDs will each ensure that the records identifying the subjects will be kept confidential, yet such records will be available for CRDF auditing purposes pursuant to the terms of this Agreement, as permitted by applicable law and/or regulation.

8. Adverse Event Reporting: POs and PI/PDs will each comply with all applicable reporting obligations related to human subjects protections including but not limited to:

   1. unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance;

   2. any suspension or termination of IRB/IEC approval; and

   3. if the research is subject to FDA jurisdiction, any serious adverse event.

   4. a copy of such report must be furnished as soon as practicable to CRDF.

9. Inspection: POs and PI/PDs shall notify CRDF immediately by telephone or telefax if any governmental agency requests permission to and does inspect the facilities and research records POs and PI/PDs during the term of this Agreement and will provide CRDF with: (i) copies of all materials, correspondence, statements, forms and records which POs and PI/PDs receive or obtain pursuant to the inspection; and (ii) copies of, or a log of all materials, correspondence, statements, forms and records provided to the inspecting agency as CRDF may reasonably request.

10. Proposals Lacking Definite Plans for Involvement of Human Subjects: If POs and PI/PDs each submits a proposal that does not currently but may subsequently involve human subjects during the period of funding, POs and PI/PDs will ensure that no human subject is involved in nonexempt research activities supported by an Award without prior review and approval of such human subject activities by an IRB/IEC. IRB/IEC approval must be provided to CRDF prior to the disbursement of any portion of the Award for human subject related activities.