Frequently Asked Questions for Researchers

Do I need IRB Review?

If your study involves people or their data, you will need to consult with the appropriate DOE IRB Administrator/Manager.  The IRB Administrator/Manager will use the following approach:  1) determine whether the study is "research"; and if so, 2) whether it is “research involving human subjects.”   If the answer to both those questions is yes, your study will require IRB review.  Additional information can be found here.

Types of IRB Review

There are three levels of IRB review of human subjects research:  exempt, expedited and full board.  The level of review of the study that is required is primarily determined by the level of risk to the human subjects.

Exempt:  Exempt studies are still a type of human subjects research and are treated as such. The research study poses little risk to the participants but has benefit to the public.  While there are 8 categories of research that are considered exempt under the Common Rule, only four are commonly applicable in the research undertaken by DOE researchers or funded by DOE: 

  • Studies of normal education/practices
  • Educational tests, surveys, and observation of public behavior
  • Benign behavioral interventions
  • Secondary research for which no informed consent is required

Expedited:  The risk to participants in the research study is minimal and all procedures and methods used in the research are included on the list of eight published categories.  Briefly, these categories include:

  • Biological samples collected by minimally invasive or non-invasive procedures
  • Data collected through noninvasive procedures used in routine clinical practice, with the exception of microwaves or x-rays
  • Materials that have been or will be collected solely for non-research purposes
  • Collection of data from voice, video, digital or image recordings made for research purposes
  • Individual or group characteristics or behaviors; and survey, interview, oral history, focus group, program evaluation, human factor evaluation or quality assurance methods
  • Minor modifications to studies that were reviewed by the full committee.

Full Committee:  Studies that are greater than minimal risk or fall outside of the expedited categories are reviewed during a convened meeting of the full IRB. 

IRB Review Process

The IRB review process can be broken into the following basic steps

  • Determination of whether the research meets, or may meet, the definition of human subjects research (Note: This determination is not made by the researcher or research team, but rather through interaction with your human subjects protection lead and/or the IRB/IRB office)
    • Issues to be aware of before making your submission to the IRB
  • Submission of the study to the IRB
  • IRB review
  • After approval by the IRB

Studies Requiring Notification to DOE

According the DOE Order 443.1C certain new human research studies, even those that meet the definition of exempt human subjects research, require notification to the DOE/NNSA Human Subjects Protection Program Manager prior to initiation.  These are studies involving

  • An institution without an established IRB
  • A foreign country
  • Potential for significant controversy
  • Research subjects in a protected class that is outside the scope of research that the reviewing IRB typically encounters, or
  • Generation or use of classified information.

Events that Are Immediately Reportable to the IRB

When conducting human subjects research, please be aware of incidents that may occur that impact the subject or their data.  Some of these may be listed on the informed consent.  To remove any question about what events should be reported, DOE takes the position that when any event is identified as out of the ordinary (whether listed in the consent form or not), it must be immediately reported to the Administrator of the DOE IRB responsible for the study.  Complaints and non-compliance must also be reported including any deviation from the approved protocol regardless of impact to the subjects.

If you have any question about whether to report an event, report it.  The IRB Administrator will work with the researcher and the DOE/NNSA Human Subjects Protection Program Managers, if needed, to investigate and document the issue to determine if any corrective action is needed to resolve the issue.

Amendments/Modifications

Any planned change to the protocol approved by the IRB must be submitted to that IRB for review before it can be implemented in the study.  There are two categories.

  • A minor modification does not substantially change the risk to participants, to the research design or methodology, to the qualifications of the research team, or to the facilities available to support safe conduct of the research.  Minor changes do not require full board review.
  • A major modification has the potential to alterthe level of risk to participants, research design or methodology, whether  vulnerable subjects are included, and/or procedures conducted.   These changes typically require full board review.

Personally Identifiable Information (PII) or Protected Health Information (PHI)  

When information specific to an individual participant will be collected, used, shared, or stored, the specific individual information must be explicitly stated.  These include, but are not limited to the 18 identifiers specified by the Health Information Portability and Accountability Act (HIPAA).

When PII or Protected Health Information (PHI) will be used in a study, the researcher must address a number of items which are listed here.

CITI Online Course and DOE-specific Training

DOE provides access to on-line training through the Collaborative Institutional Training  Initiative (CITI) at no cost to researchers who are at DOE sites or are funded by DOE as well as others involved in the DOE HSPP including IRB members who serve on the two Central DOE IRBs and DOE site IRBs, and DOE and DOE site Institutional Officials.

Human subjects research training is required for Principal Investigators (PIs) and project staff who will have access to personally identifiable information (PII) or have interaction or intervention with human subjects.  Initial training is required with refresher training every 3 years.

CITI training includes a variety of modules that are applied as appropriate. Contact your IRB Manager/Administrator to discuss the modules required. In special situations, alternative training may be considered. For specific training requirements for studies that fall under the Central DOE IRBs, contact the IRB Administrator. 

If your study is funded by an entity other than DOE, that organization may have additional training requirements.  You must comply with the most stringent requirements.

Please also be aware that the Central DOE IRBs (CDOEIRBs) have additional DOE-specific training requirements for all researchers and IRB members.

All training must be completed and documented to the IRB prior to initiation of review of the application by the IRB.

Closing out a study – when and how?

All research studies, including exempt human subjects research, must submit a closure application to the IRB at the completion of the study.  The study is considered complete when all activities requiring access to identifiable information are finished. Any study, including studies with exempt status, that will not be initiated or was discontinued before completion must also be closed.

Informed Consent Waivers

When the informed consent document will not include all required elements or will not be signed, a waiver must be requested.  There are two types of waivers:

  • Waiver or alteration of informed consent in which some or all of the required elements of informed consent are deleted from the informed consent document and the conditions specified in 10 CFR 745.116 are met.
  • Waiver of documentation of informed consent when all required elements of the informed consent are included in the informed consent document but the document is not signed by the participant and the conditions specified in 10 CFR 745.117 are met.

IRB Authorization Agreements

Each DOE site has regulatory oversight responsibility for human subjects research activities conducted by its researchers.  However, the 2018 Common Rule recommends the designation of a single IRB (sIRB) to review a multi-site research study when a DOE site is collaborating with multiple domestic sites in the research activities.  An IRB Authorization Agreement (IAA), also known as a reliance agreement, is put in place to designate the sIRB as the IRB of record.  The IAA is a formal written agreement that documents respective authorities, roles, responsibilities and communication between the sIRB serving as the IRB of record reviewing the research and the IRB(s) relying on the sIRB.  The IAA can be for a single study or for multiple studies.

Regardless of which IRB is designated as the IRB of record, the DOE researcher must still enter the research protocol into the electronic IRB software system.  Before any research activities can begin, the IRB of record must approve the study and the relying IRB must acknowledge that approval.  The DOE researcher is responsible for ensuring that all DOE requirements are met throughout the course of the research activities.

Data Use Agreements

In human subject’s research, a data use agreement (DUA) allows data to be shared between the data owner and the researcher requesting use of the data.  Typically, the data being requested are proprietary, include PII, PHI, or other sensitive data that can be linked to an individual (e.g., genetic data).  The DUA establishes the terms and conditions under which the data are shared.  It must be signed by officials with the authority to make such agreements for the institution.

When a DUA is needed for the study, the signed DUA must be submitted to the IRB as part of the study package for review.  If the researcher intends to share data with an outside organization during or following a study, a DUA should also be used.

It is advisable to consult with the IRB Administrator prior to finalizing any DUA.

Data Retention

Requirements for retention of research records after a study is complete can vary at the federal, state, and local level.  The federal regulations require that research records be retained for at least 3 years after completion of the study.  DOE follows this requirement for unclassified research.  However, for classified research, records must be retained permanently.  If a study uses records that fall under HIPAA, records must be retained for 6 years after the last subject completed the study activity.  When Institutional, state and local policies have more stringent policies on records retention, the investigator must follow the most stringent policy.

The records can be retained in hard-copy, electronic or other media form.  They must be accessible for inspection and copying by the IRB and authorized representatives of HHS at reasonable times and in reasonable form.

If an investigator responsible for research records leaves the institution before the required retention period expires, the investigator must identify a successor responsible for maintaining the records through the required retention period.

Projects that by DOE policy that Require DOE IRB Review

  • Studies involving Human Terrain Mapping (HTM):  This is research or data gathering activities primarily conducted for military or intelligence purposes to understand the “human terrain” – the social, ethnographic, cultural and political elements -- of people among whom the U.S. military is operating or in countries prone to political instability.  Any research in such areas requires review by the DOE/NNSA HSPP Manager and the CDOEIRB-C prior to initiation and is strictly limited to use of only de-identified data.  HSR-CHEKLIST-421-Human Terrain Mapping (hyperlink) provides examples of this type of research as well as information about how these projects are reviewed.
  • Former Worker Medical Surveillance Program Studies:  There are multiple projects that recruit former DOE contractor workers to participate in medical surveillance to evaluate health effects possibly related to specific occupational exposures received while employed at DOE facilities.  These service programs evolved from research and continue to receive an ethics review for equity related to access and consistency. 
  • Studies using Public Data/Social Media Data:  DOE O443.1C requires that all research using public data which includes social media data must be submitted to the IRB for review and determination.  When considering the use of this type of data in a study, the researcher must review the terms and conditions and the privacy agreement for that data to make sure that the proposed use complies with the use of the data.  A copy of or link to the terms and conditions and privacy agreement should be included in the documents that are in the study protocol on the electronic IRB software system.
  • Studies involving Modification of the Human Environment:  DOE laboratories receive funding to conduct research that alters the environment in private or public buildings or spaces in some way or surveys individuals affected by such alterations.  These studies require IRB review and determination.  Contact your IRB Administrator for additional information.
  • Studies Using Data/Samples that are Purchased or Require Authorization to Use: 

Access to human data or specimens that is either purchased or restricted to authorized users and governed by specific data protection rules is used in research.  When a study uses this type of human data, the study must be submitted to the IRB for review and determination.  When IRB approval is required, the information or samples must also comply with the appropriate DOE directives, such as level of security/classification and protection of PII, website terms of use agreements. Only information obtained with due authorizations and that complies with applicable requirements will be approved by the IRB.

Employees as a Vulnerable Population

Use of employees at DOE facilities by researchers is not uncommon.  The regulations are very clear in prohibiting selection of subjects based solely on availability and malleability.  Research that uses employees as the subject pool receives additional scrutiny to minimize the possibility of coercion, both real and perceived, on the subjects recruited to participate.  Contact your IRB Administrator for additional information.

Studies involving the Department of Defense or Veterans Affairs

When studies include individuals in the military or the Veterans Administration (VA), there are special requirements that must be met beyond the approval of the study by the IRB.  Because of these additional requirements, the time to final approval of a study may take longer.  To avoid possible delays in beginning your research, contact your IRB Administrator early in the planning process to identify additional requirements when your study involve the use of the DOD personnel or military veterans.

Considerations for Studies Using Big Data, Artificial Intelligence and Machine Learning

Advances in high-velocity data analytics and storage capacity have accelerated big data research.  These studies apply novel computational tools to large databases from multiple diverse sources to achieve advances in a multitude of research areas. Many times the data from these sources is either deidentified or in the public domain.  Data from multiple sources increases the probability of reidentification.  When research uses any human data from any source, the study must be submitted to the IRB for review and determination.  Given the nature of research in this area, the potential for the introduction of bias is present at numerous points.  Care must be taken in selecting the data used to develop the algorithm to ensure that it is representative of the population in which the results of the algorithm will be applied.  The researcher must vet the algorithm for scientific credibility and validity in the population in which it will be used.  The researcher must also be able to explain to the IRB the process used in developing the algorithm and potential risk and benefit to the affected populations.

Avoiding Bias in the Design/Conduct of HSR

Avoidance of bias in the conduct of research is critical to the validity of study results.  It can occur in the design, data collection, analysis, and interpretation of results.  Selection of a study population that has the characteristics of the population that will be affected by those results is crucial to minimizing harm and maximizing benefit to the affected population.   

Deidentified and Anonymized Data

The words deidentified and anonymized are commonly used to refer to data used in human subjects research.  Deidentified data protects a person’s privacy.  The data has been stripped of personal identifiable information such as name, birth date and Social Security number so that it cannot as easily be linked directly or indirectly to an individual.  HIPAA defines 18 pieces of data that must be removed from a human record for it to be deidentified.  However, deidentified data can be relinkedby the researcher to the individual, as the researcher has access to the individual’s name and/or other identifying information.  Anonymized data cannot readily be linked by the researcher back to the individual who provided the data.  If the researcher ever had the identifiable data or a link to it, the data can never be considered anonymized when used by that researcher.

With the plethora of data available in electronic form and the computational power, it is difficult to guarantee that deidentified or anonymized data cannot be reidentified. 

Human Subjects Research Database (HSRD)

The Human Subjects Research Database, or HSRD, is an internet accessible public database of DOE-funded and conducted research projects involving humans. Initiated in 2006, the database provides transparency for all DOE research studies involving humans that

  • Are funded by DOE
  • Are conducted at DOE facilities
  • Are performed by DOE personnel or contractor personnel
  • Include current or former DOE personnel or contractor personnel

The database is updated annually at the end of each fiscal year. The interactive database presents summarized and trended data across all sites at which DOE funds and/or conducts human subjects research as well as information about each specific project.