Creating and Submitting a New Non-Treatment Protocol

Creating and Preparing Study Documents

When preparing study documents for submission, use the applicable templates and guidance to ensure DF/HCC requirements are met.

Note that some of the resources on this page are for Investigator-Sponsored research only, meaning that the DF/HCC investigator is writing and developing the study. You can skip over these resources if your study has an external sponsor providing you with the protocol document.

Determining the Type of Research
Is this an interventional social-behavioral study, a secondary use and/or medical record review study? Does it involve human subjects or identifiable data?
Non-treatment research comes in a variety of types - Determining the type of research you are submitting up front is important, as different types come with different requirements. Categories of research include:
- Not Human Subject Research (NHSR)
  - - Does not meet the definition of Human Subject Research, where an investigator obtains information or biospecimens through intervention or interaction, or uses identifiable private information/biospecimens.
- Secondary Use / Medical Record Review
  - - Human subject research designed to use data and/or specimens originally collected for a different purpose, including retrospective and/or prospective chart review.
- Non-Interventional SBER (Social, Behavioral, and Educational Research)
  - - Human subject research that does not involve an intervention with the subject and does not assess biomedical or health outcomes - includes focus groups, interviews, survey procedures, etc.
- Interventional
  - - Human Subject Research that involves an intervention/experimental component where the researcher intercedes with the subject as part of the study design.
- Observational
  - - Human subject research involving non-experimental situations where behavior is observed and recorded, but does not include intervention or assess biomedical or health outcomes.
- Specimen and/or Data Banking
  - - Data and/or specimens are collected from, or about participants for research purposes.
- Ancillary
  - - The collection or derivation of new data for purposes that are separate from the main study.
- Correlative
  - - Non-experimental research in which the researcher measures two variables and assess the statistical relationship between them.
Conducting a Secondary Use or Not Human Research Study? View this 20 minute e-Learning on requirements for your research
If you are still unsure, please reach out toOHRS@dfci.harvard.edufor help!
DF/HCC PROTOCOL TEMPLATE
For investigator-sponsored research requiring a protocol document, use the DF/HCC Non-Clinical Protocol Template to write the protocol in alignment with DF/HCC requirements:
Non-Clinical Protocol Template
Do I need to obtain informed consent?
Informed consent is required for research studies*, and is based on the ethical principle of respect for persons, which is one of the three principles guiding human subjects research.
*See below for additional guidance on consent waivers and alterations.
Will your study consent subjects? if so, USE THE APPLICABLE TEMPLATE TO CREATE THE CONSENT FORM
These templates must be used for research reviewed under the DFCI IRB, and will help you ensure that all required elements of informed consent have been met.
DF/HCC Consent Form Template for Social-Behavioral Research
Pediatric Protocol Consent Template
Consent Template for Young Adult Who Has Reached Age 18
Consent Addendum Template
For additional guidance on using a DF/HCC template to create your consent form, review this e-Learning on Writing an Informed Consent Form Using DF/HCC Templates
does your study qualify for a waiver or alteration of consent, or documentation of consent?
When might the IRB waive the informed consent process?
- Retrospective chart reviews
- Secondary use of identifiable biospecimens
In some circumstances, an IRB may waive the requirement for obtaining informed consent or may approve a consent procedure that leaves out or alters some or all of the elements of informed consent.
Federal regulations require that participants provide informed consent for non-exempt research, unless the following criteria can be met:
- The research involves no more than minimal risk to subjects;
- The research could not be carried out practicably without the waiver or alteration;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
- Where appropriate, the subjects will be provided with additional information about their participation (e.g., in order to debrief a participant when using deception in research)
- If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form.
When might the IRB waive documentation of consent?
- Research that is conducted virtually, e.g., an online survey
- Research involving interviews being conducted over the phone
The IRB may also approve to waive documentation of consent, or the requirement that a participant sign a consent document. To waive the requirement that participants do not sign consent, only one of the following need be true:
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context;
- The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
- The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. In this case, the research team must explain what alternative means of documenting consent are being employed.
Please note: If you request a waiver of documentation of informed consent, for studies involving PHI, you must also request an alteration of HIPAA, which requires evidence that the research could not practicably be carried out without the waiver of HIPAA.
SUBJECT RECRUITMENT
All methods and materials used to recruit human subjects for research must be prospectively approved by the IRB.
The Partner's Subject Recruitment Policy describes types of recruitment, appropriate ways to recruit, and other requirements.
At a minimum, your plan must clearly describe:
- How potential subjects are identified
- How and by whom subjects are approached about participation
- When consent is obtained in relation to the start of study procedures
- Whether third parties (calling centers/centralized screening centers) will assist with recruitment of subjects for your site
Non-English Speaking Participants
There are currently two accepted procedures for obtaining consent from non-English speaking participants:
- Option 1 (preferred) - Full Translation of Consent Form
- Option 2 - Use of a "Short Form"
Review the DFCI IRB Policy on Instructions for Research Involving Non-English Speaking Participants for detailed guidance on the two options.
Always ensure that DF/HCC Policy CON-100: Obtaining Informed Consent is followed.
Ongoing Participation
The study team should arrange for ongoing participation for non-English speaking subjects, including having an interpreter present for study visits as appropriate, and translating other study materials (e.g., written questionnaires).
Note - all translated study materials must be submitted to OHRS along with a certificate of translation prior to use.
General Training Requirements and Systems Access
Ensure that all members of the research team complete required training per policy EDU-100 and have the necessary systems access. Use this checklist for guidance:
Checklist for DF/HCC Training requirements (HSP, GCP, Policies) and Systems Access Instructions

HUMAN SUBJECT PROTECTION / GOOD CLINICAL PRACTICE (CITI TRAINING)
Keep in mind - HSP and GCP training are both required for all research personnel - there are social-behavioral versions of both HSP and GCP, which fulfill the requirement and may be completed through CITI.
The only exception for the GCP requirement is staff who work exclusively on IRB-exempt or Not Human Subjects Research. Those individuals are only required to complete HSP.

New Investigator Training
Each PI needs to complete this one time DF/HCC training. The training can be completed at any time as an e-learning. Completion is required prior to protocol activation.
Note - If the study will be opening at additional DF/HCC sites, this training is required for each site PI.
Click here to begin the Principal Investigator e-learning
Review the DF/HCC Regulatory File - Required document list
Begin planning for, organizing and preparing the required regulatory documents for your study:
Regulatory File (Reg Binder) - Required Documents List
Keep in mind that some documents listed are specific to FDA-regulated drug or device research (e.g. Form FDA 1572, investigational product information) and may not apply to your research.

EXEMPT AND EXPEDITED CATEGORIES

Review the OHRS Info Sheet on Exempt and Expedited Categories

OHRS will determine whether a study can be determined exempt or approved as expedited depending on the type and nature of the research.

Your job as the researcher is to answer the questions in the New Protocol or Secondary Use application in iRIS clearly and completely so that the correct determination can be made.

Consider the following for

exempt or expedited research:

Exempt

Expedited

Record/Data Review
Using non-identifiable private information or biospecimens
May not include data linking HIPAA to biobanked samples
May not be subject to FDA regulations (e.g. secondary analysis for IND discovery)

May not be determined greater than minimal risk

Contact OHRS@dfci.harvard.edu with questions.

PEDIATRICS AND OTHER VULNERABLE POPULATIONS REQUIRING ADDITIONAL PROTECTIONS
The Code of Federal Regulations (CFR) outlines specific requirements to enhance protections for three specific groups in research:
- Pregnant women, human fetuses, and neonates
- Children
- Prisoners
Review the HHS OHRP guidance on vulnerable populations for additional resources, or reach out to OHRS@dfci.harvard.edu with questions.
If your research will or may involve recruitment and participation of subjects in these groups, consider what additional steps may be needed to minimize risk for your study population. These steps may include things like:
- Outlining procedures for consenting individuals with diminished decision-making capacity
- Specifying a plan to address incidental findings from your research
- Determining that the risk involved in the research is commensurate with risks that would be accepted by nonprisoner volunteers
Legally Authorized Representatives (LAR)
In some circumstances, participants may not be able to provide informed consent for themselves. Please see the DFCI IRB guidance on Legally Authorized Representatives.
INVESTIGATOR-SPONSORED MULTI-CENTER TRIALS
If you are expanding your investigator-sponsored research project to external collaborators, you may be subject to the requirements in DF/HCC policy MULTI-100: Investigator-Sponsored Multi-Center Research if the external sites/collaborators are involved in either:
- The recruitment of, or administration of an intervention to, human subjects; OR
- Collection and/or review of data that is identifiable or may be made identifiable by the investigator at that site.
Prior to expanding a trial to any external (non-DF/HCC) sites, the sponsor-investigator must fulfill several requirements, as outlined in DF/HCC operation MULTI-OP-1: Review and Approval Process for Investigator-Sponsored Multi-Center Research.
To summarize, these requirements include:
- Complete a one-time Multi-Center Sponsor Training, provided by the Office of Data Quality:
  - - Click here to complete the 25 minute eLearning
- Obtain a signed Institutional Multi-Center Approval Form from assigned institutional reviewer:
  - - Institutional Contacts for Multi-Center Review
- Ensure your approved protocol document* includes:
  - - Applicable language (e.g. subject registration procedures, drug distribution, etc.) for external, non-DF/HCC sites
    - A protocol-specific Multi-Center Data and Safety Monitoring Plan (DSMP), which is required for all interventional trials - Use the DF/HCC Multi-Center DSMP Template to ensure required components are present
* If you know you will eventually be adding external site, please include these components in your protocol in the initial submission to the IRB to avoid requiring a full protocol amendment later on.
Additional information can be found on the ODQ Multi-Center Research page.

Submitting a New Protocol

Most submissions, including the New Project Application, can be made directly in iRIS.

In order to submit a new research project in iRIS, you will need to complete training on use of the iRIS system and obtain the appropriate access. Please follow the instructions on the New Research Staff Checklist to obtain access. Review the iRIS Training and Resources Page for guidance on creating new submissions and more.

Please see below for guidance on making a new submission.

PRE-SUBMISSION TASKS
Prior to submitting your project in iRIS, certain tasks need to be completed. Depending on your study, these tasks may include:
- Communication with DF/HCC Subsites
- Notifying Contracts, Budgets and/or Grants Offices (completed via the Pre-Submission Form in iRIS)
- Verifying PI Training Requirements
- Verifying the Reimbursement Plan
For a complete list of tasks, please review the DF/HCC Pre and Post Submission Checklist.
Submitting a new project in iris
Depending on they type of non-clinical research project, you will submit one of the following directly in iRIS:
New Protocol Application (NPA)
Submit when: Human subject research where the DF/HCC site is engaged in the research, and research is assessing biomedical and/or health outcomes. This application form is used for the following non-treatment research types:
- Specimen and/or Data Banking
- Observational
- Ancillary
- Correlative
- Interventional
Non-Interventional Social Behavioral and Education Research (SBER) Application
Submit when: Human subject research that may include experimental manipulation, however, biomedical and/or health outcomes are not assessed in SBER studies. These research projects seek to improve our understanding of human behavior, attitudes, beliefs, interactions, social and economic systems, organizations, and institutions. Common methodologies may include focus groups, interviews, survey procedures, or observation of public behavior.
Secondary Use / Medical Record Review Application
Submit when: Human subject research designed to use data and/or specimens that were originally collected for a different purpose, including retrospective and/or prospective chart review. The study has a research question but no interaction or intervention with participants.
Not Human Subjects Research Determination Request
Submit when: If you believe the project does not fit the definition of human subjects research, then an NHSR determination request may be appropriate. Research is defined as a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human Subject is defined as a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, or (2) identifiable private information or identifiable biospecimens.
Still have questions?Contact OHRS for help determining the right category for your research.
- Click here to log in to iRIS.
- Review the iRIS Submission Basics e-Learning Series - Module 2: Creating Submissions
- For step-by-step instructions, please refer to the iRIS WIKI accessible via the help menu.

Documents to Submit

DF/HCC policy RCO-104: New Protocol Submission Requirements outlines required documents that need to be included in your initial submission. Only the documents that apply for your research project need to be submitted.

Protocol	The main protocol document along with any appendices or attachments. For investigator-sponsored protocols, use a DF/HCC template from the OHRS page.
Consent Form	For studies under the DFCI IRB, use a DF/HCC template from the OHRS page.
Participant-facing Materials	This may include questionnaires, surveys, diaries, information sheets and/or recruitment materials. This may also include screenshots of any websites/apps to be used by study participants as well as templates or phone scripts for communication.

New Project Review Process

Your submission in iRIS will be routed for any required feasibility, operational and/or ancillary reviews in addition to IRB review.

Investigators and study teams can help ensure a timely and smooth review process by tracking their submission and responding promptly to conditions and questions from the reviewers.

Track the status and history of reviews of your submission:

Investigators and study contacts can track the status of their submission within iRIS and see what steps are completed and what reviews are currently pending. From the Study Specific Summary page click on the Submission History tab.
For help understanding how to review the history and status of your submission, as well as when and how to contact reviewing groups, please review the following:
- iRIS Submission Basics Series - Module 4: Tracking Submissions
- iRIS WIKI Guidance: Defining Submission History/Protocol Status (detailed guidance document)
- Activating your Protocol - Tips for PI's to Ensure a Smooth Review and Activation Process (6 minute e-learning)
Responding to conditions in iris:
Study teams can respond to conditions from the IRB and any review committees directly in iRIS
Use the following resources for guidance on when and how to respond to certain conditions:
- iRIS Submission Basics - Module 5: Responding to Conditions
- iRIS WIKI: Responding to Conditions and Revising / Attaching Documents

Activating Your Research Project

Research activities cannot begin until you have received both IRB approval and a notification of study activation. These are system-generated notifications from iRIS.

Some protocols may require an Operational Readiness Checklist in iRIS to confirm all operational pieces are in place for when the study is activated.

NOT ALL PROjects REQUIRE Activation
Projects that are determined to be Non-Human Subjects Research or IRB Exempt do not require a separate activation step. The project may begin as soon as you receive the determination letter from OHRS.
Protocols that Require Activation
All other human subjects research projects require activation. After receiving IRB approval, a separate notification will be sent from iRIS once a protocol is active. Research activities may not occur until the protocol is activated.
Not All Protocols Require Operational Readiness
If an operational readiness checklist is required, the initial submission form in iRIS will indicate this and it will be requested prior to activation.
- For guidance on completing the ORC, review the iRIS WIKI: Operational Readiness Checklist: New Protocol
Once the study teams confirms they have all operational pieces in place to activate, ODQ Activation will perform the following tasks:
- - - Verify study team operational readiness and required approvals
    - Verify and update required information in OnCore (NCT #, open/close arms)
    - Verify DF/HCC training requirements (HSP, GCP, New Investigator Training)
    - Post IRB-approved documents to OncPro
    - Create and post the eligibility checklist (when required)
HUMAN SUBJECT PROTECTION (HSP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING
Required for all DF/HCC Research Personnel
- General Information
- Policy and Requirements
- Step-By-Step Guide
NEW INVESTIGATOR TRAINING
Required for new PIs. Recommended for everyone!
- General Information
- Policy and Requirements
- Begin E-Learning Now
DF/HCC SYSTEMS TRAINING
Required in order to obtain access. Follow the instructions on the New Research Staff Checklist. See DF/HCC Systems Access for more information.
DF/HCC POLICY TRAINING
Provided by direct supervisor or institutional clinical trials office.
- Review all DF/HCC Policies
- Document Training
PROTOCOL-SPECIFIC TRAINING
Required. This will be provided by the protocol PI or designee.
TASKS TO COMPLETE FOLLOWING ACTIVATION
There are tasks that must be completed outside of the iRIS system as soon as a study has activated. These tasks may include:
- Communication with DF/HCC Subsites
- Verify posted documents in OncPro / Update Regulatory File
- Confirm completion of Outside Interests Forms
- Updating study staff in OnCore and iRIS
For a complete list of tasks, please review the DF/HCC Pre and Post Submission Checklist