Lindsay McNair, MD, MPH, MSB Bio | WCG

Reviewing the FDA’s Proposed Informed Consent Rule Changes

Lindsay McNair, MD, MPH, MSB — Mon, 13 Mar 2023 19:00:47 +0000

To comply with the 21st Century Cures Act,¹ the Food and Drug Administration (FDA or USFDA) has released two Notices of Proposed Rulemaking (NPRMs). NPRMs are the initial public notice of a proposed change to federal regulations. These two NPRMs are intended to harmonize the FDA institutional review board (IRB) and informed consent regulations with the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to the extent possible.

The Common Rule was revised in 2018, and the FDA’s two recent NPRMs will harmonize the FDA regulations with the majority of those 2018 revisions. The Common Rule has been adopted by 20 federal agencies and applies to research that is conducted or supported by those agencies. One NPRM describes a potential requirement for multi-site research that is under FDA oversight to use a single IRB for the review of all study sites.² The second NPRM describes changes to FDA regulations to harmonize with the Common Rule regarding informed consent requirements, among other things.³

This paper will discuss the new proposed informed consent NPRM.

Proposed Changes

In the FDA NPRM on Protection of Human Subjects and IRBs,³ it is the proposed harmonization with the Common Rule requirements for informed consent documents that will most likely affect research sponsors. Like the Common Rule, the proposed rule would require:

(e)(1) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.³

The “key information” section, to be placed at the start of the consent form, should provide a summary of the most important information that may lead someone to decide whether to participate in a trial. Decisions about what needs to be included here may be subjective, and the information will likely vary for each study based on the study and the study population. The purpose of the study, overall duration, major study requirements (e.g., monthly study visits for 3 years) and most significant risks are often appropriate to include, but there may be additonal important information. For example, if the study population involves young adults but the study drug may cause birth defects, then the need to avoid pregnancy for years may be significant. If developing resistance to the study drug is possible or if the study drug could limit future treatment options, then that may be important information to include. It will be essential for clinical team members who understand the study drugs and the study population to think critically and carefully about what key information to include.

While no specific guidance around the content of a key information section have been provided by regulatory agencies, the Secretary’s Advisory Committee on Human Subject Research (SACHRP) provided some recommendations,⁴ based on the Common Rule requirement in 2018. Other organizations may also provide some advice; for example, WCG IRB recommends that the key information section be 1/10 the length of the overall informed consent document but not more than 3 pages even if the consent is longer than 30 pages.

FDA also includes language that reinforces general principles of informed consent, as stated below:

(e)(2) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.³

FDA is proposing to include three additional elements of informed consent, which have already been included in the revised Common Rule, at sections 21 CFR 50.25(b)(7), (8), and (9).

Section 50.25(b)(7) would require a statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
Section 50.25(b)(8) would require a statement on whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
Section 50.25(b)(9) pertains to research involving biospecimens and would require that subjects be informed whether the research will (if known), or might, include whole genome sequencing (WGS).³

FDA has also proposed to clarify in 21 CFR 50.27 that electronic informed consent is acceptable by adding a parenthetical statement to that eeffect; it would state,

“Informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated (including in an electronic format) by the subject or the subject’s legally authorized representative at the time of consent.”³

Consent Elements Pertaining to Future Use of Research Specimens

FDA has also proposed not harmonizing with two elements of informed consent that were added to the Common Rule in the 2018 revisions; instead, FDA proposed different requirements. The first of these involves the Common Rule requirement to provide subjects with information regarding the future use of data for additional research purposes.

The Common Rule language at 45 CFR 46.116(b)(9) reads as follows:

(b) [In] seeking informed consent, the following information shall be provided to each subject or the legally authorized representative: … (9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
(i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.⁵

However, FDA’s proposed new regulatory language at 21 CFR 50.25(a)(9) reads as follows:

In seeking informed consent the following information shall be provided to each subject or the legally authorized representative: … A description of how information or biospecimens may be used for future research or distributed to another investigator for future research.³

The goal of this new element in the Common Rule was to let subjects know whether their information and specimens might be used for further research without obtaining additional future consent. FDA has attempted to improve the language by making it more open ended, but it could lead to several unintended consequences.

FDA’s proposed language at 21 CFR 50.25(a)(9) is more open-ended and, in many cases, will be difficult for the sponsor or investigator drafting the consent form to complete. Future research with information or biospecimens is often not planned when writing the original protocol and informed consent form, so there would be no information to provide to the subject.

FDA’s proposed language could result in IRBs and other parties interpreting the failure to describe future secondary research in the consent form as a prohibition on secondary research without consent, which would restrict the ability to perform that research under the current regulations. Parties in research may also be concerned that the conduct of secondary research without consent could be a finding in an FDA inspection if it was not explicitly described in the consent form. Therefore, it may reduce their willingness to conduct such research, which could result in the loss of an opportunity for valuable additional information from studies.

Conclusion

IRBs, institutions, and investigators involved in the review and conduct of federally-funded research have already adopted many of these provisions in 2018 in the Common Rule, and these new informed consent requirements will have less impact. Commercial sponsors and investigators who do not participate in federally-funded research will have to update consent form templates and other documents (required element checklists, etc). Some sponsors of FDA regulated research may have already encountered the key information section requirement, if working with a local IRB that applies Common Rule requirements to all research.

The timeline for adoption of these proposed changes to the FDA regulations is unclear; it could take several months or even several years. However, forward-thinking sponsors and researchers may want to start updating their informed consent template now, as none of these changes are contradicted by current regulations. The only change WCG IRB does not recommend making now is the change regarding future use of specimens; because of the challenges described above and the potential for the requirement to change, it may be best to wait until the final regulations are released.

References:

21st Century Cures Act, Section 1002, Public Law 114-255. https://www.govinfo.gov/app/details/PLAW-114publ255
Notice of Proposed Rulemaking: Institutional Review Boards; Cooperative Research (87 FR 58752) https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research
Notice of Proposed Rulemaking: Protection of Human Subjects and Institutional Review Boards (87 FR 58733) https://www.federalregister.gov/documents/2022/11/14/2022-24689/protection-of-human-subjects-and-institutional-review-boards-and-institutional-review-boards
SACHRP Commentary on the New “Key Information” Informed Consent Requirements, October 17, 2018. https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-c-november-13-2018/index.html
Code of Federal Regulations Title 45 46.116 https://www.ecfr. gov/current/title-45/subtitle A/subchapter-A/part-46/subpart-A/ section-46.116

Note: While the term “research participant” or “research volunteer” is generally preferred, US federal regulations use “research subject”, so this paper discussing the proposed regulations has used the regulatory terminology.

The post Reviewing the FDA’s Proposed Informed Consent Rule Changes appeared first on WCG.

Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans

Lindsay McNair, MD, MPH, MSB — Tue, 28 Feb 2023 19:24:30 +0000

Watch the Webinar On-Demand

About the Webinar:

As planning and coordination for 2023 is underway, it’s imperative that study Sponsors, CROs, principal investigators (PIs), and Institutional teams understand FDA’s recently released Notices of Proposed Rulemaking (NPRMs) and pediatric research guidance and their potential impacts on clinical research. In late 2022, the FDA released two NPRMs to help standardize and streamline clinical trials in the US.

These NPRMS cover two general categories relevant to research sites and sponsors:

Single IRB Review for multisite trials
New required elements of informed consent and informed consent document organization

FDA has also released a draft guidance that directs how IRBs should assess the relative risks and potential benefits of pediatric research, a process that differs from the same assessment in adults.

This webinar discusses the details of these three documents and outline the actions that need to be taken now to ensure utmost compliance and continued efficiency for trial stakeholders.

Do you have an upcoming study that could benefit from expert reviews?

As the most experienced and trusted IRB in the industry, WCG IRB is proud to serve its clients with the highest ethical standards and world class service. To learn how you can accelerate your study timelines, get in touch now!

Contact our IRB Experts

Frequently Asked Questions

Expand the sections below to read answers to common questions related to NPRMs.

Please note: The Notices of Proposed Rule-Making (NPRMs) and draft guidance do not represent final regulations or final guidance, and they may change during the finalization process, or not be released at all. The information below is based on these proposed/draft documents, and may change. This content will be updated when new information becomes available. When these regulations and guidances are finalized, we expect to provide more information (webinars, etc.).

Can you provide links to the NPRMs and new draft guidance that were discussed in the webinar?

NPRM on Cooperative Research: https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research
NPRM on Protection of Human Subjects and Institutional Review Boards: https://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards
Draft Guidance, Ethical Considerations for Clinical Investigations of Medical Products Involving Children: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ethical-considerations-clinical-investigations-medical-products-involving-children

Can you provide a link to the webinar recording?

You can access the WCG webinar recording at the top of this page.

Are the NPRMs open for public comment?

The NPRMs were open for public comment through December 15, 2022. Comments that were submitted can be viewed here:

NPRM on Cooperative Research: https://www.regulations.gov/docket/FDA-2019-N-2175
NPRM on Protection of Human Subjects and Institutional Review Boards: https://www.regulations.gov/docket/FDA-2019-N-2175
Draft Guidance, Ethical Considerations for Clinical Investigations of Medical Products Involving Children: https://www.regulations.gov/docket/FDA-2022-D-0738

Could the final regulations and/or final guidance have content that was not in the proposed regulations/draft guidance?

Yes, that is possible, although FDA would generally try to have all the changes they foresee in the NPRM or in a draft guidance so that they can get public comment. There may be changes made as the result of those comments as well.

What is the anticipated timeline for these requirements to become final?

It is very difficult to anticipate the timeline for these requirements to be final. It may be a year or so, or it might take several years. When they are released, there will be time provided for affected parties to review the final requirements and prepare for them. For the NPRM on Cooperative Research, the proposed effective date will be 1 year after the final rule is published in the Federal Register. For the NPRM on Protection of Human Subjects and Institutional Review Boards, the proposed effective date will be 180 days after the final rule is published in the Federal Register. There is also the slight possibility that FDA will decide not to move forward with these requirements.

Would these requirements apply to studies already in progress?

When issued, they will not apply to studies already in progress. They will only apply to research initially approved by an IRB on or after the proposed effective date.

Do these new proposed elements also apply to consent in healthy volunteer studies?

Yes.

Is there more information available about what should be included in the key information section?

To date, there is no formal guidance on this topic. We hope that the Office of Human Research Protections (OHRP) and FDA will issue guidance to assist in the consistent interpretation of these regulations.

Will the sample consent form template on the WCG IRB website be updated to include this section?

The sample consent form template on the WCG IRB website already includes guidance for including a key information section. It was added when this became a requirement for studies regulated under the Common Rule and has been encouraged for FDA-regulated studies since then, as we knew that the harmonization of requirements was coming eventually.

Are there any drawbacks to sponsors making these changes to their informed consent templates now, even though they are not required?

No. The new proposed requirements do not contradict any existing requirements. Studies regulated under the Common Rule already require key information sections in their consent forms, and some local IRBs apply this to all research they review, so sponsors may already be encountering sites where this is a requirement.

Does this apply just to the use of specimens (blood or tissue samples) or to the data that may already have been obtained from analysis of those specimens?

It applies to both the specimen (and future analyses) and any data which has already been obtained.

How detailed does the statement about future use need to be?

That is unclear. Hopefully FDA will release guidance on its expectations in this regard if it decides to adopt this language

What if the samples have been de-identified?

If the samples have been completely de-identified so that they are truly anonymous and cannot be linked back to any individual participant or their medical history, this does not apply.

Is the new proposed required language still required if you use a separate biobanking consent form?

The main study consent and the biobanking/ future use of specimens can be two separate documents- it will not be required that you cover future use of specimens in the main consent if you have a separate form for that. But that if new language is required that would still have to be in that separate form. That is, having a separate biobanking form would not be a way to get around this language requirement.

How does this requirement overlap with HIPAA obligations? If PHI is being used for research, IRBs must stay open due to the minimal risk to the subjects. Does that change with these?

HIPPA regulations and the FDA regulations are separate. Therefore, any requirements of the HIPAA regulations would have to be met regardless of the FDA regulations not having the same requirements. If the IRB needs to keep a study open for compliance with HIPAA requirements, it will need to do so regardless of the fact the study could be closed under the FDA regulations.

If participants are in a follow-up phase and not undergoing any study procedures but long-term collection of SAEs is continuing, can IRB oversight be closed out?

If the information still being collected would be information gathered in the course of normal clinical care, then IRB oversight can be closed. If the information is in addition to normal clinical care, or if the investigator collecting the information is not someone who would normally have access to the information (e.g., the investigator is a specialist who is no longer seeing the participant to provide clinical care), then IRB oversight should continue.

Are a “single IRB” and “central IRB” the same thing?

Effectively, yes. “Central IRB” has tended to be used to refer to an independent IRB that provides review for multiple research locations that do not have their own IRB (research facilities, private physician practices, etc.). “Single IRB” seems to be the preferred term to indicate that one IRB would have oversight for multiple study sites regardless of whether those sites have their own IRBs. But in practice they are the same thing.

What if the local IRB refuses to cede review to the single (central) IRB?

If the local IRB refuses to cede review, the site will not be able to participate in the research study.

Can our local IRB still require us to submit the protocol to them for review in addition to the single IRB review?

They can. Local IRBs or institutions can put any additional processes, approvals or reviews on top of the process of single IRB review. If there is a single IRB, though, the local IRB review will have no regulatory standing; there cannot be two IRBs overseeing the same study/site. Even if the local IRB disapproves the protocol, if the single IRB has approved the protocol, the research is IRB-approved. While the Human Research Protection Programs (HRPPs) or research administration of institutions may add some additional processes or checks (ensuring coordination with budget and contract offices, requiring approval from other institutional departments that will contribute resources, etc), it is hoped that processes will not be so duplicative that they contradict the purpose of reducing administrative burden the single IRB requirement is intended to achieve.

Will local IRBs disappear if the Single IRB requirement goes into place?

Maybe, at some small institutions that do a lot of FDA-regulated research. But at most institutions, probably not. Especially at larger institutions, there is still a lot of non-FDA-regulated research, unfunded investigator-initiated research, student research, and other research that requires oversight. The local IRB may have training, quality assurance and other functions as part of the overall Human Research Protection Program (HRPP) at the institution that remain important.

Will a reliance agreement between the local IRB and the Single IRB be required?

We believe that FDA will still expect that there be a reliance agreement between the institution where the research is conducted and the single IRB.

Will the Single IRB mandate apply to IND and IDE- exempt studies?

As currently written, no. These are an exception to the requirement.

Would the Single IRB requirement apply to ongoing studies that are already approved at multiple local IRBs?

No. If this becomes a requirement, there would be a period of time before the requirement becomes effective for new studies, and ongoing studies would not be impacted.

What ages does “children” or “pediatrics” apply to with respect to this guidance?

In this context, as defined in the federal regulations, “Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” In most cases this means 18 years of age although there may be exceptions in some states where the age of consent is different from 18, or in certain medical situations where state law allows minors to consent to specific types of treatment without parental permission (e.g., treatment of sexually transmitted infections).

Please note that this is different from the age cohort distinction of neonates/ infants/ children/ adolescents that CDER uses for pediatric drug legislation, which is intended as a biologic/ scientific distinction.

Is the implication of these requirements that research in healthy children can never be more than minimal risk?

In many cases that is correct, but there are possible situations where there can be a prospect of direct benefit to healthy children. For instance, the inoculation against an infectious disease through an experimental vaccine could be justified as providing the potential for direct benefit to children who are currently healthy.

If more than minimal risk procedures cannot be allowed in a placebo arm, how does that correlate with the FDA’s requirements for a “well-controlled trial”, which often means a placebo control?

This is an ethical dilemma, where the competing demands of providing appropriate protections for children conflicts with the need to conduct well-controlled clinical trials. The resolution of this dilemma will be very case specific, and alternative appropriate trial designs will need to be considered.

If the protocol specifies that participants in the placebo arm roll over to open label administration of study drug at some point in the trial, would component analysis allow for greater-than-minimal-risk procedures to be performed during placebo phase?

This is very much an “it depends” situation where there is no specific guidance. If the blinded period were only a few days to a couple of weeks, and the procedures were a minor increase over minimal risk, an IRB might be comfortable that all the participants getting placebo would reach the study drug phase, and thus they might be comfortable approving the study. If the blinded period is several weeks or months long, and/or included multiple or riskier procedures, it would be more difficult to find that study approvable, in part because the participant may not be in the study long enough to get to the study drug phase, and then they’ve had the risks with no direct benefit. If the open label roll-over is promised but not actually submitted as part of the review (e.g., “an open-label cross-over extension is planned” or “will be submitted”), it cannot be considered a potential direct benefit.

How does the minimal risk/more than minimal risk versus direct benefit assessment relate to whether the signatures of one or two parents are required?

Under 21 CFR 50.55(e), “Where clinical investigations are covered by § 50.53 or § 50.54 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.” In other words, if the IRB approves research with no prospect of direct benefit and more than a minor increase over minimal risk, then the signatures of both parents are required, with certain exceptions.

For the assent process, does the FDA require the assent to be obtained on a separate document or can the minor sign on the main informed consent document/ parental permission form along with the parents?

The FDA does not specify how this should be handled or documented and leaves this up to the IRB to determine. The sponsor/ researcher can certainly suggest an assent/ parental permission process that would be feasible and would be appropriate based on the physical and/or developmental age of the pediatric participants. For older adolescents, it may make sense to collect a signature on the same document as the parent. For younger children who could not read at the grade level of a parental permission form, having them sign a form they can’t read or understand would not be appropriate, and if documentation of assent is required, a simple form at their reading level is more appropriate.

How does this new guidance affect single-patient expanded access/ compassionate use in children?

It should not affect single-patient expanded access at all. In expanded access (which is not considered research), the patient is always getting the investigational agent, so there is the prospect of direct benefit.

Will the medical review divisions of FDA be considering component analysis as part of the review of protocols when they are submitted to INDs? The conundrum created is that the requirement for potential for direct benefit incentivizes the design of single arm studies with no placebo, which is a less scientifically strong study design.

Yes, we agree that that is a conundrum. We hope that the medical review divisions will consider the component analysis requirements when discussing potential study designs with sponsors and when reviewing protocols submitted to INDs, or that they will consult with the pediatric ethicists within FDA on these issues. We have seen some difficult situations where a study design has been agreed upon between the sponsor and the FDA reviewing division, but the IRB cannot approve it as designed.

If a procedure or intervention fails the 21CFR50.51-53 review, is special review required for the entire list of procedures or only those which have failed?

The review would most likely focus on the acceptability of the procedures that were more than minimal risk, but the entire protocol will be considered.

If a study has to go to 21CFR50.54 special review, what is the timeline?

There have not been enough examples of this situation to provide a very good estimate of the time; in the example discussed in the webinar, it was about 8 weeks from the referral of the protocol to FDA for 21CFR 50.54 review to a full, in-person Advisory Committee meeting (in 2017). The shift to virtual or partly-virtual meetings over the last few years may help to compress this timeline.

The post Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans appeared first on WCG.

Do we need to submit screenshots of eCOA/ePRO diaries?

Lindsay McNair, MD, MPH, MSB — Tue, 16 Aug 2022 21:13:26 +0000

Question:

“If we are using an electronic tool for Clinical Outcome Assessment (eCOA), and the instrument was submitted for IRB review in document form before it was converted to electronic form, do we also need to submit screenshots of the electronic version?”

Response:

WCG IRB does not request screenshots of electronic COA instruments if either:

it is a standard, validated, commonly-used electronic questionnaire (e.g., SF-36) or
if the content was submitted in its non-electronic form (e.g., as a word document), the WCG IRB has approved the content and nothing is being changed in the electronic version except the presentation/ display.

While ICH GCP requires that the IRB review all participant-facing materials, the primary concern of the IRB is to review the content of any evaluation instruments and questionnaires to make sure there is nothing promotional or unduly influential about the study or the study intervention, and that any risks that may be associated with the instruments are recognized and minimized (e.g., if there are questions that could trigger or reveal suicidal ideation in a study of severe depression). It would be very rare for reformatting from document to electronic form to change these risks or the risk consideration, therefore requiring screenshots when the content has already been reviewed and approved does not add any real benefit.

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Drafting a Research Plan for IRB Review and Research Conduct: Information That Must Be Included in a Clinical Trial Protocol

Lindsay McNair, MD, MPH, MSB — Mon, 18 Jul 2022 21:01:17 +0000

A clinical trial is an interventional clinical study, in which participants are recruited for the administration of a specific intervention (use of a study drug, a procedure with a medical device, an educational intervention, etc.). Planning for a clinical research trial includes the development of a clinical protocol document. There are several reasons to have a clear and well-written protocol:

So that the research plan is clearly defined to everyone who will participate in conducting the study, and all processes and procedures are clearly and completely described to avoid variation in procedures and the introduction of assessment bias into the study conduct
So that oversight committees and agencies (Institutional Review Boards (IRBs)/Research Ethics Committees, scientific review committees, radiation safety or other committees, and regulatory agencies such as the Food and Drug Administration (FDA)) can review the research proposal in enough detail to ensure that it meets regulatory requirements to grant approval for the research conduct
So that the endpoints, study design, data collection parameters, and the data analysis plan are prospectively defined prior to the research being conducted, and bias cannot be introduced by changing the design or analysis plan during the study (for this reason, many journals now require public posting of the full research protocol along with the publication of study results).

There are many ways to outline and describe the necessary components of the research protocol and plan, and there are many protocol templates that are available to serve as guidelines for protocol development. In this paper, we are addressing these requirements from the perspective of the IRB. Federal regulations dictate specific criteria against which the IRB must review all protocol submissions, to make an independent determination regarding whether the prospective research plan can be approved. If the protocol (or other documents such as the IRB submission form and consent documents that accompany the protocol in the submission) does not provide adequate or complete information for the IRB to make a determination that all criteria have been met, the IRB cannot approve the research plan. This document is intended to assist investigators and research teams by providing a list of the necessary information that they can use as a writing guide, or use as a checklist against the protocol and submission document package, to ensure that all the necessary information is included prior to submitting the protocol and plan for review by an IRB.

TABLE 1 lists the criteria for the approval of research (paraphrased here from the full regulatory language in 21 CFR 56.111) by an IRB, and describes the information that is necessary for the clinical protocol (or elsewhere in the research plan submitted for review), for the IRB to be able to make determinations regarding whether a research plan can be approved.

TABLE 2 describes additional components or documents that may need to be included, based on specifics of the study product or the study plan.

In addition, all protocol documents should:

Be final documents. Draft protocols or other study documents should not be submitted for IRB review as the IRB must review final and complete study plans. If edits or changes are made after IRB review, the amended protocol must be resubmitted for approval of the changes.
Include page numbers and/or section or outline numbering so that the location of content can be identified
Include a table of contents
Include some kind of version control notation (either a version number or version date) so that revisions of the documents can be clearly tracked.

TABLE 1: Necessary Information for All Protocol Submissions

Criterion for Approval of the Research Proposal:

That risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Corresponding Information required in the Protocol/Research Plan:

A clear and detailed list of all study procedures, including screening and follow-up procedures (often in tabular format, describing the procedures to be conducted at each study visit). “Procedures” includes (but is not limited to) study visits; interviews for the collection of safety or other data; vital sign measurements; surveys, questionnaires, or diary completion; study drug administration or other investigational study intervention; invasive and non-invasive procedures including blood draws, radiologic tests or other diagnostic testing.
The protocol should very clearly define what visits, assessments and procedures would be occurring as part of standard care
If participants need to leave the study early or suddenly, the protocol should include any specific testing or follow-up that may need to occur for safety purposes.

Criterion for Approval of the Research Proposal:

That risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

Corresponding Information required in the Protocol/Research Plan:

Study background that clearly describes the scientific basis for the study, the unmet need, the research question, the rationale for the endpoint selection, and a summary of supporting literature to explain
- the scientific knowledge expected to result from the research project
- the potential direct benefits to individual research participants in the study
The protocol should also contain a clear and complete description of the study drugs/study intervention including (as appropriate) dosing information, storage information, and criteria for dose modification or dose adjustments.

Criterion for Approval of the Research Proposal:

That the selection of subjects is equitable.

Corresponding Information required in the Protocol/Research Plan:

Complete and detailed list of all criteria that would make a participant eligible to participate in the research study, and all criteria that would make a participant ineligible to participate in the research study. These are usually provided as two separate lists. If not clear from the background information, the rationale for each criterion should be explained. If a specific population is being included or excluded because of a regulatory requirement or request (for example, a pharmacokinetic study that will enroll only persons of a certain racial or ethnic background) it is helpful to explain that in the protocol.
- Eligibility criteria should be designed to make the study as inclusive as possible while excluding persons with factors or conditions that unacceptably increase the potential risks, or unreasonably confound the measurement of study endpoints
- Consider demographics, medical history and co-morbidities, concomitant medications, and whether the protocol must include testing for the presence or absence of conditions specified in the criteria
- It is not necessary to specify opposite factors in both lists, i.e., if inclusion criterion is age ≥ 18, the exclusion does not need to specify age < 18.

Criterion for Approval of the Research Proposal:

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.

Informed consent will be appropriately documented or appropriately waived.

Corresponding Information required in the Protocol/Research Plan:

While the protocol submission must include a written informed consent document, it should also describe the process of obtaining informed consent from participants; how they will be identified and contacted, who will approach them about the study, and how they will be given adequate opportunity to ask questions during the consent discussion
The written informed consent document must provide all of the elements required by federal regulations
If potential participants may be incapable of providing informed consent and consent must be provided by legally authorized representatives, the consent process must describe this and the consent form must have appropriate signature spaces
While there are circumstances in which the regulations allow either a waiver of documentation of consent (no signature) or a waiver of obtaining consent for standard or for emergency research, if a waiver is requested the submission should describe how the proposed research meets the specific requirements for these waivers, and how participants’ rights and privacy will be protected if the waiver is granted.

Criterion for Approval of the Research Proposal:

When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.

Corresponding Information required in the Protocol/Research Plan:

The protocol should include an adequate description of the safety and efficacy data points that will be collected, including how adverse events will be collected, recorded, graded, and assessed
How will safety data be monitored on an ongoing basis to identify any unanticipated safety issues during the study? Who will review the data, and will the study include a Data Safety Monitoring Committee, Data Monitoring Committee, or Adjudication Committee?

Criterion for Approval of the Research Proposal:

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Corresponding Information required in the Protocol/Research Plan:

The protocol or associated documents should describe how the privacy of participants will be protected (including if appropriate how people will be approached about the study and given the opportunity to ask questions in a private setting), as well as how the data being collected will be anonymized or de-identified, stored, transferred and analyzed to maintain confidentiality.

Criterion for Approval of the Research Proposal:

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Corresponding Information required in the Protocol/Research Plan:

Note that federal regulations have specific sections for additional precautions required in the research when research is conducted on children, pregnant persons, and prisoners. Inclusion or exclusion of these groups should be specified in the eligibility criteria.
Consideration should also be given to whether the protocol should include specific steps for the protection of participants who may be unable to make consent decisions (temporarily or permanently).

TABLE 2: Additional Components to Include when Appropriate

Circumstance or Condition:

If the protocol is evaluating the safety and/or efficacy of a drug, biologic or medical device (even if the drug, biologic or medical device is already FDA approved).

Additional information or documents that must be provided:

The regulatory status of the drug/device must be provided to the IRB, either via

a description in the protocol,
the submission form, or
a copy of a letter from the FDA.

For drugs or biologics, the documentation must include an (Investigational New Drug (IND) number or a regulatory-based rationale for why the product is considered IND-exempt (21 CFR 312.2).

For medical devices, the documentation must specify whether the device is used ‘on label’ (for exactly the same indication and circumstances for which is has already been FDA-cleared or approved) or is investigational. If the device
is investigational, the documentation must include an Investigational Device Exemption (IDE), an NSR justification, or a regulatory-based rationale for why the device is considered IDE-exempt.

When the protocol is evaluating interventions for foods, herbal products, dietary and other supplements, vitamins, and cosmetics, a regulatory-based justification for why that agent is not considered a drug or biologic as used in the research must be provided. Remember that foods that are being researched for possible use as drug products (looking for evidence of action in diagnosing, treating or mitigating a disease or condition) are regulated as drugs.

The IRB must ensure that research is being conducted in compliance with FDA regulations, so submitting appropriate documents or explanations may prevent questions during the review process. If the IRB cannot confirm documentation, or if the IRB is not completely sure that the FDA would agree with the justification for why certain research would not need FDA oversight (i.e., would be IND- or IDE- exempt), the IRB must ask the researcher/sponsor to consult with FDA and obtain documentation that FDA agrees that their oversight is not indicated.

Circumstance or Condition:

Some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant persons, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

Additional information or documents that must be provided:

When persons from vulnerable populations may be enrolled in the research the research plan must always specify this and consideration should also be given to whether the protocol should include specific steps for the protection of participants who may be unable to make consent decisions (temporarily or permanently).

Note that federal regulations have specific sections for additional precautions required in the research when research is conducted on children, pregnant persons, and prisoners.

Circumstance or Condition:

The study includes the use of surveys, questionnaires or other instruments (quality of life assessments, etc.).

Additional information or documents that must be provided:

If the protocol includes the use of surveys, all survey questions must be submitted as part of the protocol, an attachment to the protocol, or a supplemental document. If standardized questionnaires or instruments are being used, these must also be submitted. The IRB is required to review all participant-facing materials, including participant diaries and participant recruitment materials [note: some IRBs, including WCG IRB, do not require submission of common, standard instruments such as the SF-36, but if there is any doubt about whether submission is required it is better to add it and avoid possible delays].

Circumstance or Condition:

Study participants must provide written informed consent.

Additional information or documents that must be provided:

The informed consent document must be provided for review and must have all the elements required by regulations.

Circumstance or Condition:

A waiver of informed consent documentation is being requested.

Additional information or documents that must be provided:

In addition to the regulatory-based justification for the waiver (see Table 1), a Participant Information Sheet must be included in the submission.

Circumstance or Condition:

A waiver or alteration of HIPAA requirements is being requested.

Additional information or documents that must be provided:

A regulatory-based justification must be provided specifying how the research is eligible for the waiver or alteration.

Conclusion

For researchers new at conducting clinical research or writing protocols, developing a new clinical trial protocol that is complete and sufficient for the purposes for which it will be needed is often a larger and more time-consuming project that was initially expected. While IRBs are generally happy to provide information and to answer specific regulatory questions in advance of a protocol being submitted, most do not have the resources or capacity to provide one-on-one guidance to researchers who have protocols that need major revisions to meet the criteria for approval.

Researchers may find it best to work with an experienced medical writer or clinical research consultant; while the cost of these services can be significant, this may be the most cost-effective plan when balanced against the time saved by the researcher and the facilitation of the review and approval process when guided by someone who is familiar with clinical research regulations.

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Complex Clinical Trial Protocol Designs: The Effect on Research Sites and the Role Central IRBs Play in Ensuring Quality

Lindsay McNair, MD, MPH, MSB — Mon, 13 Jun 2022 18:04:34 +0000

About the Webinar

Randomized controlled trials have historically been the “norm” for the clinical research industry when looking to demonstrate the efficacy of a new therapy or treatment. As the field grows and looks to become more efficient, make go/no-go decisions quicker, and minimize the time and burden for stakeholders, new study types are being designed. While the introduction of these new trial types provides immense promise, there are headwinds research personnel are facing that we must solve.

Join our speakers during this 45-minute discussion as they:

Outline emerging new trial design types and illustrate their utilization
Provide data and insights into the implications these new study designs bring to research sites, with a focus on rising protocol amendments and the need to retrain research staff
Share the site perspective: what one research site is dealing with after seeing an influx of new study types come their way, and how they’ve had to evolve their thinking
Showcase how organizations, like central IRBs, can help ensure quality and adherence to regulations during this time of change

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Can a protocol get IRB approval during the 30-day IND waiting period?

Lindsay McNair, MD, MPH, MSB — Mon, 02 May 2022 20:45:12 +0000

Question:

Can a protocol get IRB approval during the 30-day IND waiting period?

Response:

When opening an Investigational New Drug (IND) application with FDA, federal regulations give FDA a 30-day window in which to raise any concerns about the application or proposed clinical protocol that would prevent the study from starting, by placing it under clinical hold. Usually, the “safe to proceed” news is not communicated in a formal letter, but as a “no news is good news” lack of clinical hold notification during that 30-day window, as noted in CFR21 Part 312.40.

An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.
CFR21 Part 312.40

Sponsors who want to be ready to move forward with their study often ask if they can submit for IRB review, and receive IRB approval for the protocol, before the 30-day waiting period has elapsed. According to the regulations, this is allowed, and WCG IRB will grant full protocol approval during this period. Waiting for the 30-day window to elapse before moving forward with the study is still the responsibility of the sponsor, even if full IRB approval has been granted. Sometimes WCG IRB is aware, based on the documents provided during IRB submission (usually the letter from FDA acknowledging the IND submission, which may be submitted to document the IND number), that the IND is still within the 30-day window. In these cases the Certificate of Approval might include a statement to the sponsor/investigator that they should wait until the 30 days are complete but would be a courtesy reminder only, and not a condition of approval.

For future protocols that are submitted as amendments to the existing IND, the same process is true; IRB approval of the protocol can be granted while the IND protocol amendment is still under FDA review. Since there is no dated latter of FDA receipt of the submission in these cases that would be submitted to the IRB, the IRB would not know when the submission occurred or whether the IRB was reviewing within the 30-day window, so Certificates of Approvals for these protocols almost never include the reminder to wait through the FDA review period, although to do so would still be the responsibility of the sponsor. The regulations are clear that the IRB approval and FDA review both need to happen but can be in any order (CFR 21 Part 312.30).

Whenever a sponsor intends to conduct a study that is not covered by a protocol already contained in the IND, the sponsor shall submit to FDA a protocol amendment containing the protocol for the study. Such study may begin provided two conditions are met: (1) The sponsor has submitted the protocol to FDA for its review; and (2) the protocol has been approved by the Institutional Review Board (IRB) with responsibility for review and approval of the study in accordance with the requirements of part 56. The sponsor may comply with these two conditions in either order.
CFR 21 Part 312.30

Although the question is less-frequently asked about Investigational Device Exemptions when the product being developed is a medical device rather than a drug/biologic, the same timing can occur in those cases as well, with IRB approval occurring while the IDE review is ongoing.

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Does my customer survey project require IRB review?

Lindsay McNair, MD, MPH, MSB — Mon, 25 Apr 2022 18:23:55 +0000

Question:

We are asking our customers to complete a survey on their experience with products they bought from our company. We will then share the customer feedback on our website so that other people can be more informed when making decisions about the product. Are these individuals “human subjects”? Is IRB approval required to conduct these surveys?

Response:

In deciding whether a project is human subject research under the US federal regulations (the Common Rule), the first question you should ask is whether the activity meets the regulatory definition of research.

The Common Rule defines research as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” According to the Office of Human Research, a “systematic investigation” would likely involve a hypothesis, research question, and a plan to systematically collect and analyze data. “Generalizable knowledge” is information that can be broadly applied to field of study, a population, or a discipline.

It may also be useful to consider the definition of research described in the Belmont Report, “…the term ‘research’ designates an activity designed to test a hypothesis [and] permit conclusions to be drawn…” Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.”

Gathering information about a customer’s satisfaction or experience with a product would not likely meet the regulatory definition of research requiring IRB review when those activities are intended to guide a customers’ decision about purchasing a product rather than to add or contribute to generalizable knowledge. Therefore, the “about whom” question that helps decide if the project is regulated as human subjects research doesn’t need to be considered, since this isn’t the type of “research” to which those regulations apply.

Get expert insights on your upcoming IRB review. Learn more today.

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Increasing Clinical Trial Participation Through Eligibility Expansion and Inclusivity Considerations

Lindsay McNair, MD, MPH, MSB — Mon, 11 Oct 2021 20:35:14 +0000

Watch the Webinar On-Demand

About the Webinar

In the last few years, greater attention is being paid toward ensuring that as many people as possible can participate in clinical research. The often-cited statistic that only 5% of cancer patients enroll in clinical trials doesn’t reflect that most non-participants have no trial options for which they are eligible. To open research participation, we need to consider both how we develop eligibility criteria in clinical protocols to allow the broadest possible range of participants, and we need to look at how we present and conduct trials, to make sure that they are welcoming and inclusive to everyone and to all communities.

In this webinar, our speakers will discuss:

Recommendations for the expansion of study eligibility criteria in trials to be more reflective of real-world populations
Suggestions to make clinical research more welcoming, with a specific focus on inclusion for the LGBTQIA+ community

Meet the Speakers

Dawn Flitcraft (Moderator)

President, WCG IRB

Carl Streed Jr., MD, MPH

Assistant Professor of Medicine at Boston University School of Medicine

Dr. Streed is also Research Lead for the Center for Transgender Medicine and Surgery at Boston Medical Center.

Lindsay McNair, MD, MPH, MSB

Chief Medical Officer, WCG

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Making Clinical Research Inclusive: Strategies to Include the LGBTQIA+ Community in Research Trials

Lindsay McNair, MD, MPH, MSB — Thu, 10 Jun 2021 15:33:35 +0000

In the last few years there has been an increase in attention to and awareness of the long-standing problems with diversity and the inclusion of under-represented populations in clinical research. Much of the work and discussion about diversity has focused on the important issues around racial and ethnic diversity, but there are other aspects of diversity we need to consider as well.

In order to appropriately include all communities in clinical research, and to answer important research questions that impact all communities, we also need to make sure that research is welcoming to and inclusive of people who are of all genders and sexual orientations. Unfortunately, the traditional structures of studies, templates that we use for protocols and informed consent documents, and data that we collect are often designed in ways that fail to address the specific needs and demographics of the LGBTQIA+ population. In this paper, we will talk about why it is important to collect information in clinical research studies about gender identity and sexual orientation and will discuss specific ideas for making studies inclusive of and respectful to the LGTBQIA+ community.

Why it is Important to Collect Information About Gender Identify and Sexual Orientation

As we look at the epidemiology of diseases and conditions, there are several issues which disproportionally impact the LGBTQIA+ community. Existing data demonstrates that

People who identify as lesbian, gay or bisexual use tobacco at rates that are 40% higher than in people who identify as straight/heterosexual; tobacco use is a major risk factor for multiple different cancers¹
People who identify as lesbian, gay or bisexual have a higher prevalence of depression and mood disorders compared to straight/heterosexual people, which is often linked to discrimination, bullying and harassment²

However, failing to collect information about gender identity and sexual orientation means that there may be other diseases, conditions, and risk factors which are a significant problem in this community that we are not aware of. It may also mean that we are missing the opportunity to learn about how interventions or treatments have different efficacy or safety issues in LGBTQIA+ persons which could inform both individual decisions and public health efforts. Inclusiveness in health care considerations for transgender persons is essential as well; for example, transgender men (assigned female at birth) can have “women’s diseases” such as endometriosis that are often misdiagnosed3, and transgender women (assigned male at birth) may still need regular screening for prostate cancer.

Even for risk factors that we know are disproportionally affecting the LGBTQIA+ community, we still may not collect the necessary information, as pointed out by the Deputy Director of the National LGBT Cancer Network:

“…I was very excited when the FDA funded Tobacco Centers for Regulatory Science, research centers tasked with understanding how tobacco affects people, especially vulnerable populations like LGBTQ persons. Yesterday I read the analysis of all the science produced by these centers in their first round of funding. After the FDA and NIH invested $273M in 14 different centers, the centers published 71 research manuscripts on vulnerable populations. How many included mention of LGBTQ persons? Two. If those other studies had simply asked if their participants were LGBTQ, they could have done an analysis of how our communities were affected and reported the results in all the manuscripts.”⁴

Collecting information about gender identity and sexual orientation would, in most studies, mean the addition of just a few demographic questions at a screening visit. The collection of this data would contribute to the understanding of health issues of, and treatments for, the LGBTQIA+ community as a whole, and for the individuals and groups who comprise this community.

“By not asking questions about these characteristics, our health care and public health systems are forgoing critical information necessary for designing and implementing effective strategies not just for closing disparities affecting specific populations but also for providing person-centered care and services to the U.S. population as a whole.”
Ensuring That LGBTQI+ People Count — Collecting Data on Sexual Orientation, Gender Identity, and Intersex Status⁵

Making Sure That Protocols Are Designed to be Inclusive

Differentiating Between Sex and Gender

While often used as synonyms, the terms “sex” and “gender” have different meanings. “Sex” refers to the assignment of the male or female label, usually at birth, based on physical and biological characteristics. While sex is often thought of as binary, about 1/1500 newborns will have genetic or physical characteristics which do not clearly fall into either male or female categories, and the parents may choose which sex to assign. These individuals are often referred to as “intersex” or “difference of sexual development“ (DSD) and their identity as they grow up may or may not match the sex to which they were initially assigned.

“Gender” refers to the social construct of how a person identifies themselves within society. A “gender identity” is a person’s own gender and how they want to be seen in the world, and the sex they were assigned at birth may not align with the gender they know themselves to be. In the collection of demographic data, clinical studies should collect information about both sex (assigned at birth) and gender; there may be scientific reasons why recording sex at birth is necessary (e.g., for interpretation of drug pharmacokinetics, etc.), and recording current gender is respectful and provides additional information about how the study data can be interpreted and generalized (see Table 1 for examples of inclusive and appropriate language).

Avoid Gender-Specific Pronouns

Over the last few decades, we have generally moved away from assuming the gender of persons in certain roles; that is, we no longer default to assuming that physicians are probably male or nurses are female, or refer to an unknown physician as “he” or unknown nurse as “she”. However, the frequent terminology of using “he/she” or “he or she” to refer to a person who might be any gender still excludes persons who may not define themselves as traditionally only male or only female. Using the singular “they” is appropriate not just for persons who may define themselves as non-binary, it is appropriate as an inclusive and gender-neutral term to refer to an unknown person.

Be Careful About Assumptions of Heterosexuality

In many clinical protocols (and informed consent documents) it is common to see statements like “all women of child-bearing potential must use contraception.” This statement assumes both that all females are in sexual relationships in which they may become pregnant, and that all persons who
can become pregnant identify as female. Similarly, the statement that “all males must use contraception” assumes that all males are in heterosexual relationships and that all persons who are sperm-producing identify as male. Minor wording changes (see examples in table) can ensure that the precautions about contraception are conveyed to the appropriate participants, without making assumptions about either gender identity or sexual orientation.

Consider Study Materials and Trial Awareness Campaigns

If your study uses printed or online recruitment materials or participant information materials, look at them carefully to ensure they present an inclusive and welcoming message. Do the photos in the materials include only images of pairs who appear to be traditionally male/female? Are there images of persons who present as gender non-binary? Is the language used gender-neutral? Are you planning outreach efforts into LGBTQIA+ communities? All of these considerations will convey a message of inclusion. Asking LGBTQIA+ patients, and patient advocacy groups, to participate in the development of outreach and communication materials may be helpful and appropriate.

Summary

While efforts to advance the diversity of clinical trial populations and to expand the inclusion of under-represented populations in research studies often focus on race and ethnicity, we should also be addressing the systemic issues
that have prevented the development of comprehensive health information about the LGBTQIA+ community. Minor changes to clinical protocols, informed consent documents and data collection forms can have a tremendous impact on both allowing the analysis of data in a way that allows us to better understand and treat the health care needs of this community, and can make studies more welcoming and inclusive so that persons who are part of the LGTBQIA+ community feel comfortable and safe in participating.

Examples of Language Revisions for Protocols, informed Consent Documents and Data Collection Forms

Protocol Language

Exclusive & Gender Specific Language	Inclusive & Gender Neutral Language
“Inclusion criterion: male or female adults”	“Inclusion criterion: adult persons of any sex and gender”
“Women of childbearing potential must use contraception…”	“Persons who are having sexual relationships in which they may become pregnant must use contraception…”
“All males must use contraception…”	“Persons who are having sexual relationships in whichtheir partner may become pregnant…” -OR- “Sperm-producing persons in a sexual relationship with someone who could become pregnant…”

Informed Consent Language

Exclusive & Gender Specific Language	Inclusive & Gender Neutral Language
“If you are a woman of child-bearing potential, you must use two forms of birth control”	“If you are able to become pregnant, and having sexual relationships in which you may become pregnant, you must use two forms of birth control”
“All males must use contraception”	“Persons who are having sexual relationships in which their partner may become pregnant…” -OR- “Sperm-producing persons in a sexual relationship with someone who could become pregnant…”
“The investigator and his/her team”	“The investigator and their team”
“Each study participant must allow access to his/her medical records”	“Each study participant must allow access to their medical records”

Data Collection Forms (demographic data)

Exclusive & Gender Specific Language	Inclusive & Gender Neutral Language
“Gender: male/female”	“Sex assigned at birth: Male/female Current Gender: male/female/non-binary Sexual Orientation: Lesbian, gay or homosexual/ straight or heterosexual/ bisexual/ something else/ don’t know⁶“

References

Wang TW, Asman K, Gentzke AS, et al. Tobacco Product Use Among Adults — United States, 2017. MMWR Morb Mortal Wkly Rep 67:1225–1232, 2018
Haas AP, Eliason M, Mays VM, et al. Suicide and suicide risk in lesbian, gay, bisexual, and transgender populations: review and recommendations. J Homosex. 2011;58(1):10-51. doi:10.1080/00918369.2011.534038
Lipstein, Emily. Treating Endometriosis as a Woman’s Disease Hurts Patients of All Genders. Vice Health, 11 November 2020. https://www.vice.com/en/article/xgzxkk/treating-endometriosis-as-a-womens-disease-hurts-patients-of-all-genders
Hiding In Plain Sight: LGBTQ People and Clinical Trials; Blog post 29 June 2019. https://www.facingourrisk.org/blog/hiding-in-plain-sight-lgbtq-people-and-clinical-trials
Baker, KE, Streed, CG, and Durso LE. Ensuring That LGBTQI+ People Count — Collecting Data on Sexual Orientation, Gender Identity, and Intersex Status. N Engl J Med; 384; 1 April 2021
Suggested demographic data options are from the New Patient Registration Form, Fenway Health, Boston, MA with slight modifications. https://fenwayhealth.org/info/services/forms/

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What questions can be asked when screening patients prior to them signing consent?

Lindsay McNair, MD, MPH, MSB — Tue, 11 May 2021 16:58:21 +0000

Question:

“Please clarify what questions can be asked to determine possible eligibility for screening a subject, prior to them signing consent.”
—Independent Research Center

Response:

I can’t answer questions on any specific protocols, for confidentiality reasons, but I can tell you the general perspective about pre-screening activities. Per the regulations, informed consent needs to occur before any study procedures are performed.

There are many studies and organizations (for example, commercial phase 1 units that run lots of studies) that ask general health and medical history questions to help people assess whether they might be eligible for open studies. If someone is voluntarily answering questions about their health and medical history with no tests or study-specific procedures, that’s generally considered okay before consent. Although the pre-screening questions are often submitted to the IRB anyway, just to be safe.

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