PTMS WILL PERMANENTLY CLOSE TO NEW SUBMISSIONS ON DECEMBER 20, 2018. WHEN USING CNS IRB GUIDANCE AND TEMPLATES, PLEASE REMEMBER THAT IRB SUBMISSIONS AFTER DECEMBER 24, 2018 WILL BE THROUGH IRIS.
This section covers what is needed to submit for the Initial Review of a protocol.
Please note, many of the documents listed below are not required for IRB review, but are required by other NIH offices
for different purposes before a new protocol can be forwarded to the CC Office of Protocol Services and receive final NIH approval.
The documents are listed here as a service to investigators and because the IRB assists investigators in assembling and
submitting all required documents to the Office of Protocol Services.
IRB staff determines if an Initial Review is eligible for expedited review based on regulatory guidance in
45 CFR 46.110.
The final determination of whether an Initial Review will be expedited is made by the IRB Chair.
All investigators and staff working on a protocol reviewed by the CNS IRB should take both the CNS IRB Investigator Training
and PTMS Training. CNS IRB Investigator training is required for CNS IRB Principal Investigators and NIH Associate Investigators
and staff working on CNS IRB protocols.
For information on how to upload an attachment in PTMS, consider taking the PTMS training course,
or contact the PTMS liaison for PTMS-related questions.
The Initial Review Application is required by NIH.
The information on this form is utilized by several NIH offices and for a variety of purposes.
The Initial Review Application is completed via PTMS and is launched when the PI starts a new protocol.
In PTMS, the form is labeled "Protocol Information".
It is important to make sure
that the Protocol Information page is filled out completely, accurately and consistent with other submitted documents.
Failure to do so will delay the review process.
The Protocol Information page/Initial Review application is self-explanatory.
The Office of Human Subjects Research Protections (OHSRP) has created the
"NIH Intramural Clinical Protocol Application Glossary"
which contains instructions for completing the Initial Review Application.
Directions for completing each field can also be found in PTMS by hovering
the mouse over that field.
The complete, written protocol document must be submitted with the Initial Review action. The protocol must be written using the current
CNS IRB Protocol Template.
The CNS IRB protocol template contains guidance for completing each section.
Sample language is provided within the template for some sections.
Please be sure to delete the guidance and unused sample language before submitting.
The protocol template is presented and explained in depth in the
CNS IRB Investigator Training
course. Investigators involved with any aspect of a protocol should (and may be required to) take this course.
For submission, the protocol document is uploaded to the action's attachments page in PTMS
under the "Protocol" heading. Assure that the document name has the T protocol number
(assigned by PTMS when the action is started), date and identifies it as the protocol.
Studies that will enroll participants require IRB review of the informed consent form(s) that will be used.
Studies enrolling minors or adults who are unable to consent for themselves, also need an assent form.
The consent and assent documents must be written using the current CNS IRB
The CNS consent template includes all the consent form elements required by federal regulations
and NIH policies. The CNS IRB Consent template contains guidance for completing that section.
Sample and/or required language is provided within the template for some sections.
CNS IRB standard language
for consent forms
is available in PTMS.
Please be sure to delete the guidance and sample language as necessary before submitting.
Some section headings are marked with an asterisk.
These sections are optional and should only be included if applicable.
If one of these sections is included in the consent, please delete the asterisk before submitting.
The "Introduction" section on the first page and "Other Pertinent Information" section on the last page
of the template are NIH Intramural Research Program wide consent boilerplate language.
Unless approval has been obtained from the NIH Legal Department, these sections
be changed except to add the contact information under "Other Pertinent Information" on the final page of the consent form.
Per NIH policy, and in accord with federal regulations, "To the extent possible, the language shall be
understandable by a person who is educated to 8th grade level and layman's terms shall be used in the description of the research".
The reading level of the consent document(s) is recorded on the protocol face sheet. The reading level of the consent document(s)
will need to checked and, if the reading level is significantly higher than 8th grade, the language will need to be simplified.
The boilerplate on the first and last pages should not be included in the check of reading level.
Microsoft word contains a built-in feature to assess reading level.
This link contains instructions for obtaining the
The CNS IRB has developed
language for common procedures and their risks.
If standard language is available, it should be used. The standard language includes descriptions
of the procedures and risks at an 8th grade reading level and assures that all important risks are identified.
Standard language should be used without editing whenever possible.
The same consent form should be used for different study populations whenever possible.
If the information that needs to be provided, such as on procedures or risks, differs substantially for
study populations, separate consent forms may be needed. In addition to the consent form, an assent form
is needed for studies enrolling adults without consent capacity or minors who are able to read.
If minors of disparate ages may enroll, multiple assent forms may be needed.
The incapacitated adult or minor participant signs the assent form; the legally-authorized representative of
the participant signs the consent form.
If there are multiple consent documents for the protocol, be sure to give each consent form a unique title
(in the document name and in the consent form header itself) that distinguishes it from other consents for the protocol.
The consent template is presented and explained in depth in the
CNS IRB Investigator Training
Investigators who are involved with writing the consent form, or any other aspect of a protocol,
should (and may be required) to take this course.
For submission, the consent(s) and/or assent forms are uploaded to the action's attachments page in PTMS
under the "Consent Form" heading. Assure that the consent form names have the T protocol number
(assigned by PTMS when the action is started), date and identifies the particular consent or assent form.
A new protocol must receive Institute Scientific Review approval before it can be accepted for review by an IRB.
As each Institute determines their own process for scientific review, the process varies between Institutes (and sometimes between Branches within the same Institute).
Contact the Institute Clinical Director for information on the Scientific Review process.
Scientific review must be completed before the Initial Review submission can be accepted for IRB review.
Documentation should include:
Scientific Review approval notification.
Scientific Review minutes, outside reviewer reports, notifications from the Scientific Review committee,
PI responses to the Scientific Review committee stipulations, etc.
For submission, the Scientific Review approval and supporting documentation are uploaded to the action's attachments page
in PTMS under the "Scientific Review Notice & Response" heading.
If the PI's institute requires statistical review during scientific review, the documents are handled
in the same manner as the scientific review documents (above), except that they are uploaded in the action's attachments
page in PTMS under the "Statistical Review Documents" heading.
Planned Enrollment Report
is required for all studies that meet the
NIH definition of Clinical Research.
Most protocols meet this definition and require submission of a Planned Enrollment Report.
The numeric distribution for the total number of planned participants for the study, broken down by race,
ethnicity and gender, is provided on the Planned Enrollment Report. The total enrollment number provided
on the Planned Enrollment Report must exactly match the Accrual Ceiling specified in the protocol document
and as listed in PTMS.
For multi-site studies, multiple Planned Enrollment Reports may need to be submitted. For a multi-site study
in which the NIH site is the coordinating site, a separate planned enrollment report must be submitted for each
of the following: 1) NIH Site, 2) All Other Domestic Sites Combined, and 3) Foreign Sites Combined.
For a multi-site study in which NIH is not the coordinating site, only the Planned Enrollment Report for the
NIH site needs to be completed and submitted.
The CNS IRB has compiled
on the demographic distribution of the general USA as well as the local Washington and Baltimore populations,
which may help to complete the form. This document is available under the
Resources/Forms tab of this website or in PTMS via the “IRB Forms" link.
More information on this requirement can be found at
The completed Planned Enrollment Report(s) should uploaded to the action's attachments page in PTMS
under the "Accrual Table" heading.
The completed Planned Enrollment Report form is not required by the IRB and does not need to be submitted before
the IRB can review the protocol. However, it is required before the IRB office can submit the new protocol to the
Office of Protocol Services for final NIH approval.
MAS policy M08-1
sets the requirement that each protocol establish a protocol-specific reimbursement rate for travel (i.e., local and long-distance
transportation) and subsistence (i.e., meals and lodging). To meet this requirement, the PI must complete and submit the
"Designation of Reimbursement of Travel and Subsistence (DRTS) Expenses for NIH Intramural Clinical Research Protocols"
If the protocol will not be enrolling participants at the Clinical Center, then it is not necessary to complete and
submit a DRTS form. The completed DRTS form is not required by the IRB and does not need to be submitted before the
IRB can review the protocol. However, it is required before the IRB office can submit a new protocol to the Office of
Protocol Services for final NIH approval.
The DRTS form can be accessed and completed in two different ways. It can either be completed via PTMS,
or it can be completed outside of PTMS and uploaded as an attachment into PTMS.
The DRTS form built into PTMS is accessed via the "Patient Travel" link within a protocol in PTMS.
A .pdf paper form is available under the Resources/Forms tab
of this website or in PTMS via the “IRB Forms” link. This can be completed manually and uploaded
as an attachment under the “Other” heading on the Initial Review attachments page.
For information on completing the DRTS form, contact the PI's Institute Clinical Director.
"Clinical Center Prospective Protocol Resource Impact Assessment (PRIA)"
form must be completed for all new protocols. The form helps the Clinical Center assess resource requirements for the protocol.
The PRIA form should be submitted to the CC/OD at the same time it is submitted to the IRB.
NOTE: The IRB is NOT responsible for submitting the PRIA form to the CC. The PI is accountable for submitting
the PRIA form directly to the CC at:
The PRIA form can be uploaded into the “Other” heading of the Initial Review attachments page in PTMS for documentation purposes.
For information on completing the PRIA form, contact:
All people (other than the PI) listed on the protocol face sheet (including as applicable: Associate Investigator(s),
Lead Associate Investigator, Referral Contact and Adjunct Principal Investigator) must provide documentation that they
have read the protocol and agree to participate in their designated role. The documentation may consist of:
An email from the investigator confirming their agreement. The email must clearly identify the protocol.
An investigator can sign a hard copy of the protocol application or protocol face sheet,
which can then be scanned for submission.
The investigator can provide a signed hard-copy or electronic memo.
If an investigator on the study is an NIH employee and from an Institute other than the Institute funding the study,
then documentation of that investigator's Clinical Director's approval for the investigator's participation must also be obtained and submitted.
For example: If an NIMH employee serves as an Associate Investigator on an NEI Protocol,
then the NIMH Clinical Director's approval must be obtained for the participation of the NIMH employee.
Electronic or hard-copy documentation, as noted above, are acceptable.
Hard-copy documents should be scanned. Email notices of agreements should be saved as a document.
The agreements should then be uploaded to the action's attachments page in PTMS under the "Other" heading.
The agreements from multiple investigators and CD's can be combined into a single document for uploading.
This documentation is not required before the protocol can be reviewed by the IRB, but is required before
the IRB can submit the new protocol to the Office of Protocol Services for final approval.
requires that each PI complete required training appropriate to each study.
PI training needs to be documented in PTMS for each protocol.
The PI’s training documentation should be uploaded into the action’s attachment page in PTMS under the "Other" heading.
also delineates the required training for investigators, key research personnel
and others working on the protocol. The PI is responsible for assuring and documenting completion of all
required training by each individual before s/he can work on the protocol. Documentation of training by those
other than the PI does not need to be uploaded into PTMS.
For information regarding training requirements, see SOP 25,
If the new protocol includes the use of an Investigational New Drug (IND) or
use of device under an Investigational Device Exemption (IDE), then documentation of FDA approval
must be submitted to the IRB. The IRB may request other FDA-related documents for the study.
The IRB can review protocols prior to FDA approval. The submission to the FDA can be prior to, concurrent with,
or after IRB review. If FDA approval is not documented first, the IRB approval will be contingent on FDA approval.
If the FDA requires changes, those changes will need to be submitted to the IRB for further review.
The IRB cannot provide final approval and submit the protocol to the Office of Protocol Services for processing
until FDA approval is in place and all conditions have been met.
For submission, upload FDA documents to the action's attachments page in PTMS under the "FDA Documents" heading.
For questions regarding FDA regulated research, contact the FDA directly.
Links to FDA regulations:
If the new protocol involves the use of radiation for research purposes, then Radiation Safety Committee
(RSC) approval will need to be obtained. The IRB will need the following documentation of RSC review and approval:
- Form NIH 88-23(a): Application for Authorization to Use Radiation in Research Involving Human Subjects
- RSC Approval Memo
- Any formal correspondence with RSC (e.g., RSC stipulations stemming from review and PI response to stipulations)
For questions regarding RSC review, contact the RSC directly. Information about the RSC review can be found on their
The IRB can review the submission prior to RSC approval. The submission to the RSC can be prior to, concurrent with,
or after IRB review. If RSC approval is not documented first, the IRB approval will be contingent on RSC approval.
If the RSC requires changes, those changes will need to be submitted to the IRB for further review.
The IRB cannot provide final approval and submit the protocol to the Office of Protocol Services for processing until
RSC approval is in place.
For submission, upload RSC documents to the action’s attachment page under the "Radiation Safety Documents" heading in PTMS.
Some protocol submissions must be cleared by the Institute Deputy Ethics Counselor (DEC).
The Institute Ethics Office conducts a review of the financial holdings of certain individuals
listed on the protocol to determine if they have any potential financial conflicts of interest
for that protocol. Investigators who have a potential conflict identified will be contacted by the DEC.
The DEC will work with the PI to resolve any actual or apparent conflict.
Whether or not a protocol requires DEC Clearance, depends on whether it is a "covered research protocol"
as defined in OHSRP SOP 21.
The individuals whose financial holdings need to be reported to NIH and reviewed by the DEC are those defined as “covered individuals” in the policy. The PI and covered individuals must submit forms for the DEC clearance process.
Once the DEC review is complete and any conflicts are resolved, the DEC office will provide documentation of clearance to the PI.
For more information on the DEC Clearance process, contact the Institutes Ethics office.
Documentation of DEC Clearance should be uploaded to the attachments page in PTMS under the "Conflict of Interest Documents"
heading unless done automatically by the IC in PTMS.
This documentation is not required before the IRB can review the protocol, but is required before the IRB office can
submit the protocol to the Office of Protocol Services for final NIH approval.
Data and Safety Monitoring Committee membership and monitoring plan:
If the new protocol is monitored by a Data and Safety Monitoring Committee (DSMC), then you must submit documentation to the IRB of the:
- - proposed membership of the DSMC
- - proposed charge to the DSMC
- - proposed meeting frequency/schedule of the DSMC
For submission, upload the DSMC documentation to the action’s attachment page under the "DSMB Documents" heading in PTMS.
The above DSMC information is sometimes included within the body of the protocol. If it is included within the protocol, then no further documentation needs to be submitted.
Note: The term “Data and Safety Monitoring Board (DSMB)” is also common and is synonymous with DSMC.
If the protocol is a multi-site study, additional information is needed for IRB review, depending on the nature of the collaboration.
Multi-Site Study and NIH is the Coordinating Site:
Submit documentation of current IRB approval from each of the collaborating sites.
Multi-Site Study and NIH is NOT the Coordinating Site:
Submit documentation of IRB approval, the protocol and consent form(s) from only the lead site.
Other Collaborative Study:
Contact the IRB Office for study-specific information on required documentation,
which varies based on the nature of the collaboration.
To submit documentation for a multi-site study, upload the documents to the action’s attachments page in PTMS under the "Other" heading.
"Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information
from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose
identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding,
whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose
information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and
promote participation in studies by helping assure confidentiality and privacy to participants."
Visit the Certificates of Confidentiality Kiosk
to learn more.
The PI and IRB make a determination if a study needs a Certificate of Confidentiality (CoC).
If so, the PI is responsible for obtaining the CoC, including information on the CoC in the protocol
and consent form, and providing documentation to the IRB.
To submit documentation of the CoC, upload it to the action’s attachments page in PTMS under the "Certificate of Confidentiality" heading.
All recruitment materials require IRB review before they can be used. CNS
IRB guidance on recruitment material requirements is available
and must be supported by information on their planned use in the
"recruitment" section of the protocol.
To submit recruitment material, upload the documents to the action’s attachments page in PTMS under the "Other" heading.
If a protocol includes
Non-NIH investigators, who will interact with participants and/or have access to identifiable private information,
then an IRB Reliance Agreement may be needed.
The NIH Deputy Director for Intramural Research (DDIR), the Director, Office of Human Subjects Research Protections (OHSRP)
and the Deputy Director, OHSRP are the only NIH officials authorized to make final decisions about entering into a Reliance Agreement.
OHSRP negotiates and executes reliance agreements.
To establish a reliance agreement or determine whether an agreement is needed, contact