Presentation of research protocols
Researchers should submit four copies of their study protocols, together with the following documentation:

1. Informed Consent Form.
2. Informed Assent Form for studies involving pediatric population (children aged 7-18 years).
3. Resumé of the principal investigator and of all people involved in the research project.
4. Study protocol in Spanish.
5. Authorization of Chairs of Services that will be affected by the study performance.
6. Study budget. Estimation of costs, including initial cost, disposable material and handling of samples when studies are performed outside the Hospital.
7. Honoraries of each participating professional and time schedule.
8. Insurance for expenses resulting from adverse effects that may arise as a consequence of the implementation of the project. These expenses are independent from those derived from the habitual medical assistance of patients.
9. Payment voucher of the initial fee.
10. Letter signed by the local agent responsible for project implementation, determining whether the care of patients recruited for the study will modify the routine care of patients before project implementation. In case of changes, they should be detailed in said letter.

Items 6, 7, 8 and 9 are concerned with study protocols for the pharmaceutical industry.

Each application will be reviewed for completeness by IDIP´s secretary.

Fees and initial payment

An initial non-refundable review fee will be deposited in IDIP´s account, Cooperadora del Hospital de Niños, upon project submission.

Protocol evaluation

1.  Protocols will be forwarded to the Scientific Committee for pertinence and quality assessment by at least two reviewers. Review results should be submitted in writing within 30 days.
2. Projects will be returned to the authors for corrections, if any. Approved projects will be sent to the Ethics Committee. Rejected protocols will be returned to the responsible researcher.
3. At least 5 members of the Ethics Committee will review the protocol and issue their comments in writing within 30 days of protocol reception. Protocols will be returned for corrections, if any, as suggested by reviewers.
4. The final approval/rejection letter will be signed by all CIRPI members involved in protocol evaluation. A copy of said document will be delivered to the responsible researcher.
5. IDIP´s Board of Directors will forward the approved protocols together with a copy of CIRPI´s decision to the Ministry of Health, for final consideration according to regulations in force.

 
The institutional cost of development of an approved protocol will be 25% of the total implementation cost.

Adverse effects in approved protocols

The local responsible researcher should submit in writing all adverse effects that may arise during the implementation of the study. The information will be then forwarded to the Scientific Committee together with a list of all the adverse effects, dates, populations and institutions where such effects were produced and reported. The researcher should also include a scientific explanation supporting the continuity of  study implementation. The Scientific Committee will be responsible for the analysis and reception of the above mentioned information and for forwarding it to the CIRPI. In the case of double-blind trials and presence of adverse effects in the study population, IDIP has the right to interrupt the study when the local responsible researcher, the laboratory or the organizing entity cannot base their judgement on scientific or ethical grounds.