Research

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Office of Clinical Investigation

This website is designed to assist the clinical research community in safeguarding the rights and welfare of human subjects who participate in research. Children's Hospital has established a human research protection program to assure full compliance with all federal regulations, state laws and hospital policies governing the use of human subjects in research.

News and Announcements  

An overview of required registration requirements for ClinicalTrials.gov is now available.
Investigators should familiarize themselves with the  requirements to register in order to meet  FDA regulations and ICJME  publishing requirements.
ClinicalTrials.gov: Review of Registration Requirements

An important Human Subject Protection newsletter is now available.
The articles in this newsletter include:
New ClinicalTrials.Gov Oversight at BCH
Facilitating Protocol Submissions through CHeRP
Using the review status tab
Using the Reportable event from
Submitting DSMB Updates
Adding Non-BCH Employ-
Welcome Meghan Cashman 6
Memo To File: From the EQuIP Office
Struggling with CHeRP?
Clinical Research Center (CRC) Services

2014 June Newsletter

An important Human Subject Protection newsletter is now available. Please take the time to review this information. The articles in this newsletter include:
1. New Policy on Research Involving Decisionally-Impaired Adults
2. New Consent Form Template
3. Memo To File: From the EQuIP Office
4. Pre-Review Helpful Hints
5. Update on CCI Jurisdiction
6. What Human Subject Training Satisfies the IRB Education Requirement?
7. Welcome, Siena Napoleon!
Please click here for more information:
2012 September Newsletter

The U.S. Department of Health and Human Services announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. They have provided an advanced notice of proposed rulemaking. This provides the government with an opportunity to receive comment on specific topics  before actually proposing regulations, Children’s Hospital has submitted comments which may be found at:
Please click here to see the comments

We also encourage investigators to review these proposed changes and submit comments either individually or thorough their respective professional organizations. Information on how to submit comments can be found at:
http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html

New Policies
Two new policies have been posted on the Clinical Investigation website. They are "Genome-Wide Associated Studies Policy and Procedures" and "ClinicalTrials.gov". Please review this important information if either policy pertains to your research.

Genome-Wide Associated Studies Policy and Procedures

ClinicalTrials.gov

All Departments/ Divisions are now live on CHeRP!
All departments are expected to use CHeRP for all new submissions. Any PI who is starting a new application (full protocols, medical record/ specimen, emergency requests) will be required to use CHeRP. You will not longer find protocol applications on our website. Protocols that are submitted in paper WILL BE RETURNED.

Remember in order to submit a new protocol electronically the PI and anyone designated to help the PI within CHERP must have completed CHeRP training. 
Please click here for more information

Short Consent Translations
The Committee on Clinical Investigation will now allow the use of short consent document translations in several commonly understood languages. This abbreviated translation or "short form" (which attests that the elements of consent have been presented orally) may be used to document informed consent in writing for individuals who do not speak English in limited situations.
Please click here for more information.

New Policy for Unanticipated Problems and Adverse Events
The Committee on Clinical Investigation has revised and clarified its policies on reporting unanticipated problems, adverse events and deviations to the IRB.
Please click here for more information.

Education Requirements
For information regarding the education requirement for researchers, please see:
Education Requirement
Information regarding the continuing education requirement can be found at:
Continuing Education Requirement

The Committee on Clinical Investigation has revised and clarified its policies on reporting minor and significant deviations to the IRB
The Committee on Clinical Investigation has revised and clarified its policies on reporting minor and significant deviations to the IRB. In addition there is no longer a separate significant deviation form. Please use the newly revised unanticipated problem form which has a specific category for significant deviations. Please see the November 2008 Special Communication Newsletter for more information.
Please click here for more information

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