The CCI (“Committee on Clinical Investigations”) is your official “IRB of record.” If you are a BIDMC researcher conducting, or planning to conduct, research with human subjects (including their data or samples) completely or partially at BIDMC facilities, at approved off-site locations/facilities, regardless of the sources of funds, you are required to use the CCI as your IRB.

What if I Am an HMFP Employee?

Researchers employed by Harvard Medical Faculty Physicians (HMFP) must submit to the CCI for review regardless of where the research will occur.

Not all research is Human Subjects Research requiring IRB approval.

How Do I Know if This Fact Applies to My Research?

If you are conducting research with data or specimens from humans, consider the following questions:

• Did you intervene (for example, with a drug, device, or behavioral intervention) with living human beings to obtain the data or specimens?
• Did you interact in any way (for example, via an online survey) with living human beings to obtain the data or specimens?
• Did the data or specimens have any identifiers (consider all HIPAA identifiers) linked to them when you received them?

If your answer to all of these questions is “no,” chances are you are not conducting Human Subjects Research, which means you do not need IRB approval.

What if I’m Not Sure?

If you are not sure whether you are planning to conduct Human Subjects Research, our IRB (CCI) has a process to help make the correct determination. For more information about how Human Subjects Research is defined, or what constitutes an “identifier” visit the CCI website: https://portal.bidmc.org/Intranets/Research/CCI-IRB/CCIIRBFrms/DetrofHumSbjRsrch.aspx

Note that while IRB approval may not be required to conduct the research, you may need to work with other offices, such as the Clinical Trials Office, Office of Compliance and Business Conduct, or the Technology Ventures Office, to conduct the research.

All BIDMC staff hired in a research role will be assigned the ‘New PI and Study Staff Orientation’ training in myPath. This must be completed within 60 days of assignment. This training only needs to be completed one time.

All BIDMC clinical research personnel must complete the Basic Human Subjects Protection module in CITI Training. Additionally, you must complete a CITI refresher course once every three years.

For anyone participating in research involving an IND and all IDE holders must also complete the CITI Good Clinical Practice (GCP) module.

You must be either a BIDMC employee, or have staff privileges at BIDMC, or have an HMS faculty appointment through BIDMC in order to be the Principal Investigator on an IRB approved study.

What if I Am a Fellow or a Resident?

Fellows and residents cannot be the PI on an IRB application. The same is true for students. They can, however, be co-investigators on the study, provided they have completed the required human subjects research training mandated by the CCI.

Can I Be the PI on a Study Even if a Fellow or Resident is Conducting the Research?

Yes, BUT, as the PI you are still accepting responsibility for oversight of ALL aspects of the study. Ultimate responsibility for how the study is conducted rests with you.

For more information about investigator responsibilities refer to the CCI Policy Manual:
https://portal.bidmc.org/Intranets/Research/CCI-IRB/CCI-Policy-Manual.aspx

If you plan to conduct “cancer-directed” research at BIDMC you may need to obtain IRB approval from the Dana Farber/Harvard Cancer Center (DF/HCC) IRB.

How Do I Know if This Fact Applies to My Research?

If you are conducting human subject research for which the intent is to improve outcomes or care for cancer patients, you must submit an application to the DF/HCC IRB. This includes not only studies for which cancer patients are research subjects, but may include, for example, studies of providers intended to understand how care is delivered in this patient population. This applies even if the BIDMC is the only study site.

Am I Still Required to Submit Something to the BIDMC IRB (CCI)?

You do not have to submit to the CCI. The DFHCC has formal authority as the reviewing IRB for all institutions that conduct cancer-directed human subject research under the Dana Farber/Harvard Cancer Center grant.

For more information refer to the CCI Policy Manual:
https://portal.bidmc.org/Intranets/Research/CCI-IRB/CCI-Policy-Manual.aspx

How Do I Begin the Process?

If you are in the BIDMC Department of Surgery and plan to conduct a study that may require review by the DF/HCC IRB, contact Catrina Crociani immediately (ccrocian@bidmc.harvard.edu)

Once the CCI (Committee on Clinical Investigations) determines that your human subject research is exempt, you do not have to make further submissions for that study to the CCI, UNLESS you change the study in such a way that it no longer meets the exemption criteria.

What Kinds of Changes Am I Required to Report to the CCI?

If you make changes to the scope of your study such that it could increase the risk, you must submit your changes to the CCI. The kinds of changes that can increase risk and do require submission to the CCI are:

• Change in study design
• Change in study population
• Change in Principal Investigator
• Change in study staff

The CCI will then make a determination whether the research still meets the exemption criteria.

What Happens if I Change My Study So That It Is No Longer Exempt?

The CCI will determine whether the revised study qualifies for the expedited review process under one of the expedited categories, or if the study requires review by the full board. The CCI will instruct investigators as to any further submission requirements.

For complete details about exempt and expedited criteria and categories, and the criteria for review under the human research regulations, refer to the CCI Policy Manual:
https://portal.bidmc.org/Intranets/Research/CCI-IRB/CCI-Policy-Manual.aspx

Even exempt human subjects research requires a consent process under certain conditions.

How Do I Know if This Fact Applies to My Research?

If you plan to conduct a human subjects research study that requires a determination of exemption from the IRB, and you are interacting with subjects for the research, you are still required to have a consent process.

Keep in mind that interaction includes:

• Face-to-face surveys or interviews
• Telephone surveys
• Online surveys

What Must the Consent Process for my Exempt Research Include?

You must have a consent process that conveys, at a minimum, the following points:

• A statement that the activity is research
• A statement describing what the research involves
• A statement that participation is voluntary
• Contact information for the PI

This information can be conveyed in an introductory email, preamble to a survey, or hand out.

For more information about exemptions or informed consent, review the CCI Policy Manual:
https://portal.bidmc.org/Intranets/Research/CCI-IRB/CCI-Policy-Manual.aspx

“Exempt” research is not exempt from IRB review. Exempt research is “exempt” from the federal regulations, but only after the IRB has determined that it meets the regulatory definition of exempt. The IRB must review and make this determination before the research can begin.

How Do I Know if This Fact Applies to My Research?

Some human subjects research that is very low risk and meets any one of the federally designated categories of research is considered “exempt” from the human research regulations. If the research you are planning meets exemption criteria, you must submit an application to the IRB and obtain a determination of exemption before you begin the proposed research.

Is an Exemption Determination Different from a “Determination of Not Human Subjects Research”?

Yes! Exempt research is human subjects research and requires submission to the IRB for review and determination prior to beginning the work. This means that your project must also be reviewed and approved by a Scientific Review Officer (SRO) to ensure that it meets acceptable scientific standards.

For more information refer to the CCI Policy Manual:
https://portal.bidmc.org/Intranets/Research/CCI-IRB/CCI-Policy-Manual.aspx

If you have completed your IRB-approved study, you must complete and submit a final continuing review progress report to the IRB to terminate the study.

How Do I Know When to Terminate My IRB-Approved Study?

If you are conducting a non-exempt study you can terminate the study by completing a final progress report when:

• You will no longer have any interactions with research subjects, AND
• You will no longer need to access identifiable data

If you are nearing the expiration of your IRB approval and these two conditions aren’t met, you must submit a progress report for continuation.

What Happens if I Do Not Submit a Final Progress Report?

If an investigator allows a completed study’s IRB approval to expire without submitting a final progress report, the study is reported to the Committee as Permanently Expired and cannot be reinstated. Our IRB has a strict policy about allowing studies to expire:

An investigator with two permanent expirations in a 12-month period is prohibited from submitting new IRB applications for a period of six months. Your human subjects research may also be audited since failure to submit progress reports is a violation of CCI Policy.

For more information about Continuing Review, Permanent Expiration, or what constitutes an “identifiable data” review the CCI Policy Manual:
https://portal.bidmc.org/Intranets/Research/CCI-IRB/CCI-Policy-Manual.aspx

Note that if approval expires you must stop all research activities until your study is reapproved. If you have questions about your expiration date, or about what you may or may not do if your study expires, contact your CCI Protocol Coordinator.

If you are conducting human subjects research at more than one institution, or with a colleague at another institution, you may not need duplicate IRB review. You may be able to rely on the review of one IRB.

What Does it Mean to “Rely” on Another IRB?

The BIDMC IRB (CCI) has formal agreements with certain institutions that allow one institution to rely on the review and oversight by another IRB. This is often referred to as the “cede review” process. This means that investigators submit their IRB applications and all subsequent paperwork and submissions to one IRB. There is still, however, a formal process for requesting “cede review” and it is not an automatic, or guaranteed approval.

What does the IRB take into consideration?

There are a number of factors that the CCI takes into consideration when deciding whether to cede review to another IRB. The CCI considers the nature of the study and risk to subjects, the institution and the reviewing IRB, and the qualifications of the PI and the study team.

If you plan to change the PI on an IRB approved study, or add/remove co-investigators or study staff, you must submit the following forms to the CCI.

To change the PI of the study:

• Amendment form signed by the new PI and the old PI
• Revised (with tracked changes) and clean (with changes accepted) versions of Parts A, B, and P, and as applicable, Parts E, G, the informed consent form, and the HIPAA Waiver of Authorization signed by the new PI.

To add/remove co-investigators and study staff to the study:

• Amendment form signed by the study PI
• Part Q completed and signed by the new co-investigator
• For internal staff:
  • Revised (with tracked changes) and clean (with changes accepted) version of the Research Staffing Form
  • o If new co-investigator will be prescribing, then a revised and clean version of Part E is also required
• For external staff:
  • The Collaborator Request form is required along with revised and clean versions of the Research Staffing Form, Part Q and the external staff members CITI Training Documentation