Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

The FDA recently released a guidance document on IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. This document indicates that the FDA will not object to IRBs granting waivers or alterations of consent procedures, provided that:

1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 

The studies that are conducted at my organization are all no more than minimal risk. My department lead is very excited that this will allow us to do away with our standard consents requiring signature and replace it with something simpler with a statement along the lines of "your completion of these questionnaires indicates your consent..."

I'm hung up on requirement #3, however. What do you have to show to argue that the investigation could not practicably be carried out without the waiver or alteration? I don't think we can necessarily show that.

You are correct to be concerned about requirement 3. Informed consent is always important.

Perhaps you should ask your department lead how they would explain the impracticality of obtaining consent. If they can generate an explanation that you can agree on; that will pass a clinical/legal review, you can proceed down that path.

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David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O - (828) 862-8555
M - (828) 508-6535
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Original Message:
Sent: 08-Aug-2017 09:51
From: Anonymous Member
Subject: IRB Waiver of Informed Consent for No More Than Minimal Risk Research

This message was posted by a user wishing to remain anonymous

The FDA recently released a guidance document on IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. This document indicates that the FDA will not object to IRBs granting waivers or alterations of consent procedures, provided that:

1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The studies that are conducted at my organization are all no more than minimal risk. My department lead is very excited that this will allow us to do away with our standard consents requiring signature and replace it with something simpler with a statement along the lines of "your completion of these questionnaires indicates your consent..."

I'm hung up on requirement #3, however. What do you have to show to argue that the investigation could not practicably be carried out without the waiver or alteration? I don't think we can necessarily show that.

There is always a tough one, huh?  Office of Human Research Protection has opined on this criterion in the past, but basically the term 'Practicably' requires more than mere inconvenience. Researcher must provide substantial evidence that not waiving consent will be intrusive (well beyond "slowing down the process") and add confounding bias to the research such as delaying immediate needed health care thus placing subjects in health crisis. 

Note that is not a completely new set of criteria from the Common Rule.  To me the bottom line is that you still have to submit the protocol to an IRB for an assessment of whether informed consent can be waived.  Most IRBs are going to have the criteria in their application forms that define the criteria they will use to waive consent.

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Glen Park
Scynexis, Inc.
Jersey City NJ
United States
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Original Message:
Sent: 08-Aug-2017 09:51
From: Anonymous Member
Subject: IRB Waiver of Informed Consent for No More Than Minimal Risk Research

This message was posted by a user wishing to remain anonymous

The FDA recently released a guidance document on IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. This document indicates that the FDA will not object to IRBs granting waivers or alterations of consent procedures, provided that:

1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The studies that are conducted at my organization are all no more than minimal risk. My department lead is very excited that this will allow us to do away with our standard consents requiring signature and replace it with something simpler with a statement along the lines of "your completion of these questionnaires indicates your consent..."

I'm hung up on requirement #3, however. What do you have to show to argue that the investigation could not practicably be carried out without the waiver or alteration? I don't think we can necessarily show that.

I think you are correct to be worried about #3. My opinion is that this change will mainly impact use of registry data or collective hospital "big data" where retroactively consenting patients could be impractical.

------------------------------
Michael Nilo
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 08-Aug-2017 09:51
From: Anonymous Member
Subject: IRB Waiver of Informed Consent for No More Than Minimal Risk Research

This message was posted by a user wishing to remain anonymous

The FDA recently released a guidance document on IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. This document indicates that the FDA will not object to IRBs granting waivers or alterations of consent procedures, provided that:

1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The studies that are conducted at my organization are all no more than minimal risk. My department lead is very excited that this will allow us to do away with our standard consents requiring signature and replace it with something simpler with a statement along the lines of "your completion of these questionnaires indicates your consent..."

I'm hung up on requirement #3, however. What do you have to show to argue that the investigation could not practicably be carried out without the waiver or alteration? I don't think we can necessarily show that.

My understanding was that this exception was primarily for emergency patient care where the patient might be unconscious or not comprehending and where there is no parent/guardian at the site of care. 

I would proceed with caution and fully document the circumstances under which the data can be collected without Informed Consent and what level of post-treatment attempts are to be made to later acquire consent for use of the data collected.

------------------------------
John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States
------------------------------

Original Message:
Sent: 11-Aug-2017 13:24
From: Michael Nilo
Subject: IRB Waiver of Informed Consent for No More Than Minimal Risk Research

I think you are correct to be worried about #3. My opinion is that this change will mainly impact use of registry data or collective hospital "big data" where retroactively consenting patients could be impractical.

------------------------------
Michael Nilo
Nilo Medical Consulting Group
Portland OR
United States

Original Message:
Sent: 08-Aug-2017 09:51
From: Anonymous Member
Subject: IRB Waiver of Informed Consent for No More Than Minimal Risk Research

This message was posted by a user wishing to remain anonymous

The FDA recently released a guidance document on IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. This document indicates that the FDA will not object to IRBs granting waivers or alterations of consent procedures, provided that:

1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The studies that are conducted at my organization are all no more than minimal risk. My department lead is very excited that this will allow us to do away with our standard consents requiring signature and replace it with something simpler with a statement along the lines of "your completion of these questionnaires indicates your consent..."

I'm hung up on requirement #3, however. What do you have to show to argue that the investigation could not practicably be carried out without the waiver or alteration? I don't think we can necessarily show that.

​

My first guess on intent was the same as Michael's, especially given the current widespread enthusiasm for registries, which FDA seems to share, perhaps even be driving. Retrospective studies have always been a bit of a challenge due to consent issues, but usually these can be worked out, and are usually not conducted under an IND/IDE. This guidance may just acknowledge existing practice.

However, I think John may be on the mark. OHRP has its own regulations for waiver of consent for emergency use, not tied to clinical trials. FDA has its own regulations for emergency use of an investigation product, but these don't address consent. Their focus is use of an investigational product outside of an IND/IDE.  This would seem to leave a bit of a gap when it comes to informed consent for emergency use of an investigation device by a patient enrolled in a trial, where consent is normally required.

If you read the OHRP regulations, you will find that the language in FDA's guidance is eerily reminiscent:

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/emergency-research-informed-consent-requirements/index.html

I'm not sure about the need to proceed with caution, at least not from the perspective of the manufacturer/study sponsor. It's not the sponsor that gets to waive the consent requirement, but the IRB. So, if I were a device company planning a minimal-risk study, I would proceed post haste to the IRB to find out whether they will waive consent or not. And then continue my plans for the study accordingly.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Aug-2017 09:51
From: Anonymous Member
Subject: IRB Waiver of Informed Consent for No More Than Minimal Risk Research

This message was posted by a user wishing to remain anonymous

The FDA recently released a guidance document on IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. This document indicates that the FDA will not object to IRBs granting waivers or alterations of consent procedures, provided that:

1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The studies that are conducted at my organization are all no more than minimal risk. My department lead is very excited that this will allow us to do away with our standard consents requiring signature and replace it with something simpler with a statement along the lines of "your completion of these questionnaires indicates your consent..."

I'm hung up on requirement #3, however. What do you have to show to argue that the investigation could not practicably be carried out without the waiver or alteration? I don't think we can necessarily show that.