IRB and RSC Review of Research Protocols Using Radiation and Radiation Dosimetry Calculations for NIH protocols

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IRB and RSC Review of Research Protocols Using Radiation and Radiation Dosimetry Calculations for NIH protocols

May 15, 2020

Protocols will require RSC review (or RDRC if applicable) if it meets any of the following criteria: (this will be provided as a checklist in iRIS).

Uses a radioactive research drug(s) regulated under the FDA requirements for review by the Radioactive Drug Research Committee (RDRC)
Involves the use of any radiation in pediatric participants (<18 years old) with an annual effective dose >0.5 rem or healthy pediatric volunteers (any dose level)
Uses any radiation in healthy adult volunteers, excluding DEXA and chest X-Ray
Uses therapeutic administration of radioactive materials (Examples include therapeutic use of I-131, Lu-177, Y-90, Th-227, Ra-223, or Ir-192 permanent seed implants. The following would be excluded from required RSC review: Use of linear accelerator such as total body irradiation or high dose-rate afterloader such as brachytherapy for breast or prostate cancer.)
Involves novel uses of radiation, including any radioactive Investigational New Drugs (IND) and radiation-producing investigational devices
The radiation itself is the research agent being studied in the protocol (For example: the protocol compares the effectiveness of 2 different doses of radiation therapy; comparison of the effectiveness of drug X vs drug X + radiation therapy; study of the uptake and biodistribution of a novel radioactive tracer)

Protocols that fall into one of these categories will continue to be reviewed by the RSC as they are now, but submission of the required forms will be via iRIS. The RSC may determine at the time of review that continuing review by the RSC is not necessary. As noted above, RSC will be calculating total effective dose (ED) based on all radiation listed in the protocol.

Note: At the time of IRB review, the IRB may refer any protocol to the RSC for review if it deems RSC expertise is required.

For protocols that no longer require RSC review:

Investigators should calculate the total ED for all radiation in the protocol prior to IRB submission using the tools available on the RSC webpage. A dose library and totals worksheet will be provided. Using these resources, investigators should enter the scans, doses, and frequency of each specific scan will be conducted within a one-year period in the online spreadsheet. This spreadsheet will be used to calculate the total annual ED for the protocol as well as the comparable risk assessments that need to be inserted into versions B and C of the informed consent language, and it should be retained in the study’s regulatory binder. It does not need to be included in the IRB submission.

Once the investigator has calculated the total annual ED, this information must be added to the protocol and consent documents along with specific approved language regarding associated risk based on the dose range in which the total calculated ED falls (< 0.3 rem vs. > 0.3 rem and < 5 rem for adults vs. > 5 rem for adults with different approved language for pediatric participants) Investigators are responsible for ensuring that the appropriate radiation risk language is included in the consent. Consent language can be found within our consent library on the IRBO website.

These changes apply to all initial reviews submitted to the NIH IRB after May 15, 2020 unless the protocol has already been submitted for RSC review prior to that date. For protocols that are currently approved by the NIH IRB, the PI should update the protocol and the risk language in the consent at the time of the next planned amendment to include the total ED for all radiation.

For any questions regarding calculation of ED and associated consent language, please contact the RSC Executive Secretary, Teresa Fisher, at 301-496-2253 or RSCExecSec@nih.gov. For IRB related questions, please contact the IRBO at 301-402-3713 or irb@od.nih.gov.

How to Receive Email Updates About FDA Drug Label Changes

Home / IRB Members / Presentations & Reference / How to Receive Email Updates About FDA Drug Label Changes

How to Receive Email Updates About FDA Drug Label Changes

Step one

Click on this link to subscribe or manage subscriptions to FDA email updates. You will see the screen for the FDA Subscription Management Center. Enter and confirm your email address as instructed.

Step two

You will now see a list of all the possible FDA email update subscriptions. The subscription that sends out changes in approved drug labels is titled “CDER Drug Safety Labeling Changes”. You may choose any additional FDA updates that you may be interested in receiving. You can always change this later.

List of newsletter subscription options on FDA's Subscription Management System, indicating a checked box next to CDER Drug Safety Labeling Changes

Step three

Save your changes and then you are done.

irbmembers

Research Regarding Pregnant Women

Home / IRB Members / Presentations & Reference / Research Regarding Pregnant Women

Research Regarding Pregnant Women

April 14, 2020

irbmembers

Equitable Subject Selection

Home / IRB Members / Presentations & Reference / Equitable Subject Selection

Equitable Subject Selection

January 24, 2020

irbmembers

Policy Update - 2019 Q4

Home / Newsletters / Policy Update - 2019 Q4

Policy Update - 2019 Q4

By: Heather Bridge

The revision of the human research protection program (HRPP) policies is ongoing. In addition to the Policy memorandum released in January about the 2018 Common Rule requirements, 15 HRPP policies have been approved, of which three (3) have been released and are implemented. The implemented policies are located on the IRBO website. All other HRPP SOPs continue to apply, and are accessible on the IRBO website, until we release the new policies in an ordered fashion. These policies will supersede the HRPP SOPs and Manual Chapter. As we explained previously, the numbering and structure of the polices have changed. Twenty (20) additional polices have been drafted and are in the process of clearance. It looks like it will be early 2020 before all policies are cleared. We will then focus on development of Guidelines and tools to aid research teams.

AAHRPP Activities - 2019 Q4

Home / Newsletters / AAHRPP Activities - 2019 Q4

AAHRPP Activities - 2019 Q4

By: Heather Bridge

We continue to update AAHRPP (the accrediting body for the Human Research Protection Program) on the progress of the consolidation of the IRBs and streamlining of IRB operations. Our status last report in November showed significant progress over the past year since Jonathan Green and Tiffany Gommel joined OHSRP and stood up IRBO. We have more to do, but we are confident the accrediting body will see that we are making great strides towards our goal of a centralized IRB and streamlined operations.

We are preparing for the AAHRPP Annual Report, which is due in March 2020. As with previous years, we collect fiscal year data for the annual reports. We kicked off data collection in October by requesting IC QAQI data. The CC Office of Research Support and Compliance (ORSC) assists OHSRP with QAQI data collection and assessment. This year, working with OHSRP, ORSC developed a new QAQI survey to collect the needed QAQI data for AAHRPP. In addition, and they will assist us with the assessment of QAQI activities in the ICs. The remainder of the AAHRPP data collection will start in January 2020 from the ICs and from IRBO. Due to the consolidation of the IRBs that was completed in December 2019, we hope to collect IRB data from NIH iRIS. However, because this is a transitional year, we may still need some legacy IRB data from the IC-based IRB datasets, but we are still assessing our data sources. We anticipate that IRB data for these types of assessments will become far easier over time since we have now have a centralized IRB software system and centralized operations.

Notice to NIH Community RE: RSC

April 16, 2020 / Nicole Grant

IRB and RSC Review of Research Protocols Using Radiation and Radiation Dosimetry Calculations for NIH protocols

Protocols will require RSC review (or RDRC if applicable) if it meets any of the following criteria: (this will be provided as a checklist in iRIS).

Uses a radioactive research drug(s) regulated under the FDA requirements for review by the Radioactive Drug Research Committee (RDRC)
Involves the use of any radiation in pediatric participants (<18 years old) with an annual effective dose >5 rem or healthy pediatric volunteers (any dose level)
Uses any radiation in healthy adult volunteers, excluding DEXA and chest X-Ray
Uses therapeutic administration of radioactive materials (Examples include therapeutic use of I-131, Lu-177, Y-90, Th-227, Ra-223, or Ir-192 permanent seed implants. The following would be excluded from required RSC review: Use of linear accelerator such as total body irradiation or high dose-rate afterloader such as brachytherapy for breast or prostate cancer.)
Involves novel uses of radiation, including any radioactive Investigational New Drugs (IND) and radiation-producing investigational devices
The radiation itself is the research agent being studied in the protocol (For example: the protocol compares the effectiveness of 2 different doses of radiation therapy; comparison of the effectiveness of drug X vs drug X + radiation therapy; study of the uptake and biodistribution of a novel radioactive tracer)

Protocols that fall into one of these categories will continue to be reviewed by the RSC as they are now, but submission of the required forms will be via iRIS. The RSC may determine at the time of review that continuing review by the RSC is not necessary. As noted above, RSC will be calculating total effective dose (ED) based on all radiation listed in the protocol.

Note: At the time of IRB review, the IRB may refer any protocol to the RSC for review if it deems RSC expertise is required.

For protocols that no longer require RSC review,

Investigators will calculate the total ED for all radiation in the protocol prior to IRB submission using the tools available on the RSC webpage. A dose library and totals worksheet will be provided. Using these resources, investigators will enter the scans, doses, and frequency of each specific scan will be conducted within a one-year period in the online spreadsheet. This spreadsheet will be used to calculate the total annual ED for the protocol, and it should be retained in the study’s regulatory binder. It does not need to be included in the IRB submission.

Once the investigator has calculated the total annual ED, this information must be added to the protocol and consent documents along with specific approved language regarding associated risk based on the dose range in which the total calculated ED falls (< 0.3 rem vs. > 0.3 rem and < 5 rem for adults vs. > 5 rem for adults with different approved language for pediatric participants) Investigators are responsible for ensuring that the appropriate radiation risk language is included in the consent. Consent language can be found within our consent library on the IRBO website.

These changes will apply to all initial reviews submitted to the NIH IRB after May 15, 2020 unless the protocol has already been submitted for RSC review. For protocols that are currently approved by the NIH IRB, the PI should update the protocol and the risk language in the consent at the time of the next planned amendment to include the total ED for all radiation.

For any questions regarding calculation of ED and associated consent language, please contact the RSC Executive Secretary, Teresa Fisher, at 301-496-2253 or RSCExecSec@nih.gov. For IRB related questions, please contact the IRBO at 301-402-3713 or irb@od.nih.gov.

The OHSRP Education Series 2020 Informed Consent One Year after the 2018 Common Rule Revisions Updated Information and Processes

The OHSRP Education Series 2020: Informed Consent One Year after the 2018 Common Rule Revisions: Updated Information and Processes

January 14, 2020 / Nicole Grant, Peg Sanders

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