Submission Instructions and Checklist
6/08

Application Form
8/08

For research involving an intervention or interaction with human subjects. In some cases an Expedited Application Form may be used, or for research limited to Health/Medical Records and Human Material/Tissue, see limited research application forms below.

For research limited to blood collection; prospective collection of data/samples by noninvasive means; collection of data through noninvasive procedures routinely employed in clinical practice; collection of data through audiovisual recordings made for research purposes; research employing surveys, interviews, focus groups, evaluation or QA methodologies. NOTE: A full application may be required at the discretion of the PHRC chair reviewing the protocol.

Sponsor/Funding Information
4/02

Principal investigators and co-investigators must complete this form and submit to the IRB in conjunction with the Application form when the research involves ANY of the following: (1) for-profit sponsor or funding source; (2) a marketed drug, device, or other technology, or a drug, device, or other technology in development; or (3) a new technology, software or therapeutic approach.

To be included with a PHRC submission when a research study involves multiple Partners performance sites, e.g., BWH and MGH, complete the site-responsible investigator form for all sites except the overall PI's site.

Co-Investigator/ Study Staff Certification
8/07

To be included with a PHRC submission for each Co-Investigator and study staff member. Only one individual in addition to the PI should be designated as the contact person.

If non-BWH/non-MGH employees will perform institutionally designated research activities or exercise institutionally delegated authority or responsibility for research, please see the policy "Non-BWH/MGH Employees As Co-Investigators/Study Staff."

To be included with a PHRC submission when a research study involves Harvard School of Public Health (HSPH) as a performance site.

To be included with a PHRC submission unless noted otherwise in submission instructions. Summary document describes protocol and investigator's plan for recruitment and enrollment of subjects. Includes important regulatory information needed for IRB review. Refer to documents Prescreening and Recruitment Guidelines for acceptable methods of recruitment. Sample recruitment letters are available.

Schema Instructions
3/98

Instructions for investigators who are writing their own protocol for use when there is no sponsor initiated protocol or cooperative group protocol.

Individuals with Impaired Decision-making
6/05

Wards of the State
8/08

Medical Devices
6/07

Non-Hospital Inventory FDA-Approved Devices
8/08

For research involving a medical device that is being investigated or used as a comparator, or for non-FDA approved medical devices that are being used to study human physiology, complete the Medical Device form. A separate form should be completed for each medical device being investigated or used.

For research involving a non-hospital inventory FDA-approved medical devices provided by the sponsor or others that is used for research-related ancillary tests, procedures, or monitoring in accordance with the device’s FDA-approved labeling, complete the Non-Hospital Inventory FDA-Approved Devices form. A separate form should be completed for each non-hospital inventory FDA-approved medical device being provided.

For research evaluating or using FDA-approved or investigational drugs or biologics. A separate form should be completed for each drug or biologic being evaluated or used. Do not complete this form for supportive care drugs.

For research involving inpatients.

For research involving research related exposure to nonionizing radiation: ultrasound, MRI, lasers, or ultra-violet radiation.

Waiver of Informed Consent and
Authorization for Research
2/03

For research limited to the use of human material/tissue collected as part of the patient's clinical care.

Health/Medical Records
12/06

For establishment of a data repository of identifiable health information derived from patient medical records, other hospital records, or practice-based patient health information to conduct research and/or quality improvement activities. Replaces the Research-Related Patient Database form.

For research limited to the secondary use of human samples or data. Secondary use is the use of previously collected samples and/or data for a new research project.