When submitting items to WIRB for review, is the use of the submission form required?
WIRB requires that a completed initial review submission form be submitted with each initial review request and change of principal investigator request. The cover page lists the items required in the submission packet.

Also posted on the website is a Change in Research and Subject Recruitment Submission Form. Please use this form (either the "smart form" version or a paper version) to submit changes in research and new or revised subject recruitment materials.

If you need help with any of the WIRB submission forms, please contact Client Services via e-mail at ClientServices@wirb.com or by calling 1-800-562-4789.

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• Please provide confirmation from the sponsor that the change is acceptable and has been approved. The sponsor is required to select investigators under 21 CFR 312.53(a).
• Provide a letter from the current PI, relinquishing responsibility for the study (if a letter is unavailable, please indicate that it is not available and why).
• Provide a letter from the new PI requesting appointment as the new PI.
  
  In addition to the letters authorizing the change, the request should also be accompanied by:
  • A WIRB initial review submission form (ether a "smart form" version or a paper version) completed by the new PI (if you choose not to use the smart form, you may use the Investigator Submission Form for Multi-Center Protocols version of the initial review submission form)
  • Documentation of the new investigator's qualifications to conduct the study (a CV and, when applicable, a professional license)
  • An updated 1572 (when applicable) and
  • A request to update the investigator information in the existing consent documents to reflect the new investigator information

How do I submit changes to Consent Form(s)?
WIRB requires a completed Change in Research and Subject Recruitment Submission Form (either a "smart form" version or a paper version) and either a copy of the current WIRB-approved consent form with proposed changes clearly marked, or the changes can be detailed in a document specifying the requested changes.

Proposed new changes may be submitted either on a copy of the current WIRB-approved consent form with new changes tracked in redlined format or handwritten on the form, OR the changes can be detailed in a document that indicates each change and the section of the consent form where the change should be made.

For more information on submitting consent form changes, please contact Client Services via e-mail at ClientServices@wirb.com or by calling 1-800-562-4789.


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How do I obtain informed consent from someone who speaks and understands English, but cannot read the consent form?
Sometimes potential subjects speak and understand English, but cannot read due to blindness, illiteracy, or some other reason. These individuals may still participate in a research study as long as the Board has not excluded limited or non-readers and there is an impartial witness present for the consent process, in accordance with ICH 4.8.9, which states:

ICH 4.8.9 - If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects is read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject's participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative and that informed consent was freely given by the subject or the subject's legally acceptable representative.

ICH 1.26 Impartial Witness - A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

What are my choices for receiving documents from WIRB?
Based on the preferences indicated in the WIRB initial review submission forms, documents are sent via e-mail, regular mail or fax. Contact WIRB Client Services to request a change to the delivery method.

You can also access your approval documents and other research-related information 24 hours a day via WIRB's web portal called "WIRBNet." On www.wirb.com click "LOGIN" in the upper right to request an account.

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• Provide complete dual oversight of research with another IRB, in which both IRBs provide initial and continuing review of all aspects of the research (for more information about dual oversight arrangements, see below);
• Provide split dual oversight of the research with another IRB, in which WIRB provides IRB oversight for specific physical locations, and an institutional IRB provides IRB oversight of the aspects of the study conducted at the institution (for more information about split oversight arrangements, see below); or
• Assume jurisdiction from an existing institutional IRB for the review of a study or studies (for more information about a local IRB waiving jurisdiction to WIRB, see below).

• WIRB formalizes the relationship in a written agreement with the other IRB.
• WIRB has a template written agreement that can be used that specifically states that both IRBs will share information about subject complaints, findings of serious or continuing non-compliance, and any suspension or termination of the research. WIRB may use this template, or may accept a different draft from the other IRB, which may contain additional elements, but should contain the elements outlined above.
• Both IRBs approve the consent form, the protocol, and other aspects of the research, and both IRBs provide continuing oversight of the research for the duration of the study.

2. Split Dual IRB Oversight

When split IRB oversight is requested, WIRB will provide IRB oversight for all aspects of the research conducted at specified sites, while the institutional IRB will provide IRB oversight for all aspects of the same research study conducted at the institutional sites.

• WIRB formalizes the relationship in a written agreement with the other IRB.
• WIRB has a template written agreement that can be used that specifies the jurisdiction of the review of each IRB, specifically states that both IRBs will share information about subject complaints, findings of serious or continuing non-compliance, and any suspension or termination of the research, and specifically states that each IRB will follow its own written procedures. WIRB may use this template, or may accept a different draft from the other IRB, which may contain additional elements, but should contain the elements outlined above.
• WIRB provides IRB oversight for all aspects of the research conducted at named locations, while another IRB provides IRB oversight for all aspects of the same research study conducted at other locations.

3. WIRB Assumption of Jurisdiction from an Existing IRB

That is, when a hospital or other institution with an IRB waives jurisdictions over research conducted within the institution.

• WIRB may assume jurisdiction over the conduct of the research upon receiving written authorization from another IRB with jurisdiction over that research.
• The written authorization to waive jurisdiction must be signed by the IRB administrator or chairman (or other appropriate party).
• WIRB has a template written authorization that can be used that specifies that WIRB will share information about subject complaints and findings of serious or continuing non-compliance and any suspension or termination of the research, and specifically states that WIRB will follow its own written procedures. Alternatively, the other IRB may provide a letter waiving jurisdiction to WIRB without conditions or containing different elements.

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• The research involves no more than minimal risk to the subjects.
• The waiver or alteration will not adversely affect the rights and welfare of the subjects.
• The research could not practicably be carried out without the waiver or alteration.
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If you are a covered entity under HIPAA, please complete the WIRB form "Request for Full Waiver Authorization under HIPAA."

An impartial witness' signature may not be used to attest to ad hoc translation of the consent into a language different than the language in which the consent form is written.

WIRB may include a signature block for an impartial witness if an investigator indicates on the WIRB submission form that the investigator's subject population includes subjects who cannot read and the Board has not determined that the inclusion of limited or non-readers is inappropriate.

The impartial witness signature block should be left unsigned unless there is an impartial witness present for the consent process. Please see the Frequently Asked Question, "How do I obtain informed consent from someone who speaks and understands English, but cannot read English?" for further discussion of the impartial witness requirements.

5. Signature of Legally Authorized Representatives (LARs)
In research that allows the enrollment of adult subjects who are not legally competent, the consent form will include a signature block for an LAR. If an adult subject is not legally competent, an LAR must participate in the consent process, agree to the enrollment of the subject in the research, and sign the consent form. If the research allows the enrollment of adult subjects who are legally competent and subjects who are not legally competent, then the LAR signature block will be labeled, "when necessary." In this case, the LAR signature block should not be signed if the subject is legally competent. The LAR signature block will only be signed when the subject is not legally competent.

6. Assent of Children
When research includes children, WIRB follows the regulations for the inclusion of children in research, found at 45 CFR 46, Subpart D, and 21 CFR 50 Subpart D. As part of these regulations, WIRB requires assent from children as required under 45 CFR 46.408 and 21 CFR 50.55. These regulations require that children assent to participation in research unless they lack the mental capacity or unless there is a prospect of direct benefit that is not available outside of the research. WIRB generally finds that children seven years of age and older have the capacity to assent. The child's assent may be documented on the consent form in a variety of ways. The WIRB consent form will include instructions for the documentation of assent. The WIRB Certificate of Approval will note that assent is required.

7. Assent of Adults Incapable of Consent
When research includes legally cognitively impaired adults, WIRB will determine whether the assent of the cognitively impaired adults is required. ICH 4.8.12 requires that when a research study includes subjects who can only be enrolled in the study by a legally authorized representative, "the subject should be informed about the trial to the extent compatible with the subject's understanding and, if capable, the subject should sign and personally date the written consent form." For research involving this study population, WIRB generally includes the following signature block to document that assent was obtained by a representative of the study:

For subjects who have a legally authorized representative, I confirm that I have explained the study to the extent compatible with the subject's understanding, and that the subject has agreed to be in the study.

___________________________________________
Signature of Person Conducting Assent Discussion

no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

If an adult subject is not medically capable and/or legally competent to consent to participate in a study, the federal regulations require that a legally authorized representative consent for the subject. The definition of “legally authorized representative,” as described in FDA 21 CFR § 50.3 and HHS 45 CFR 102(c) is:

an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

The applicable law is the law of the state, as well as any other local law. Thus, the definition of “legally authorized representative” will be determined by state law or other local law. If a subject is medically incapable and/or legally incompetent, then a legally authorized representative, as determined under state or local law, must consent on the subject’s behalf. The Office for Human Research Protections (OHRP) has determined that state laws addressing consent for treatment decisions concerning the same procedures involved in the research are an acceptable basis for determining who may serve as a “legally authorized representative.”

Starting August 1, 2005, investigators receiving WIRB approval to conduct a new protocol allowing for the inclusion of adults who lack the capacity to personally provide consent may look forward to receiving a letter from WIRB describing their state's laws regarding Legally Authorized Representatives.

For questions regarding the legal status of an individual subject and the applicability of local law to an individual subject’s enrollment in research, contact a health care attorney admitted to the bar in that state. Sites should be aware that changes in statutes and regulations occur frequently, and that court decisions may determine or change the interpretation of such statutes and regulations. Legal counsel should always be consulted to determine the current state of applicable law.

How is consent obtained from a non-English speaking subject?
WIRB requires that non-English speaking subjects sign a WIRB-approved translated consent form. An ad hoc oral translation of the consent form is not acceptable. WIRB's Translations department can arrange to have a WIRB-approved consent form or subject material translated into any language, or the site/sponsor can submit to WIRB a translated document along with a signed translator certification statement for verification and approval. Specific submission requirements may be obtained from the WIRB Translations department.

You must also have plans for 1) conducting the consent discussion in the language understandable to the subject, and for 2) ongoing communication with the subject throughout the research and in case of emergency.

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My site is in California, but the contents of the California Experimental Subjects’ Bill of Rights don’t apply to my research project. Can I ask WIRB to omit the Bill from my approved consent form?
Yes, WIRB will consider omitting the Bill from your approved consent form -- sites that believe the Bill is not applicable to their research and that desire to see it omitted from their consent form can submit a change in research request. WIRB review fees apply for requests submitted as changes in research.

Beginning June 1st, 2010, the California Experimental Subject's Bill of Rights will not be included in the approved consent form. However, it will continue to be provided to California sites with the Initial Review approval documents.

The text of the applicable California law can be found in the California Health and Safety code Section 24174.

I have been approved to use a Humanitarian Use Device (HUD)/a device with a Humanitarian Device Exemption (HDE). Its use is not research, so how do I answer the questions on the WIRB Continuing Review Report Form (CRRF)?
Humanitarian Use Devices (HUDs) are approved devices whose use must comply with 21 CFR 814, Subpart H “Humanitarian Use Devices,” and 21 CFR Part 803, “Medical Device Reporting.” Federal Regulation 21 CFR 814.124 requires IRB review and approval of use of the device.

WIRB requires all approved, active sites provide progress reports at least annually (21 CFR § 56.109(f)). Continuing Review Report Forms are sent to sites approximately two weeks before their due date.

WIRB understands that some of the questions on its Continuing Review Report Form are not pertinent to the use of HUDs, but you must complete the applicable questions and mark the rest “NA”. See the document below for a sample form indicating which questions can routinely be marked “NA”.

PDF Version      

In situations where progress reports are not returned with accurate information in a timely manner, Federal Regulations grant the Board authority to suspend or terminate approval of the use of the device at the site (21 CFR § 56.113).

If the Board takes action to suspend approval for use of a HUD at your site, you would not be allowed to use the HUD on any new patients until the Board receives the information it requires and votes to lift the suspension.

Therefore, it is imperative that you submit the accurate and complete continuing review reports by the due date stated on the form.

The determination to require a CoC is based on whether the research involves a subject population that might be prone to face legal or social harm by another’s discovery of private, confidential, or protected information, such as:

• illegal behavior, e.g., crime, quasi-crime, supervision violation, contempt, child abuse, domestic violence, etc.;
• illegal status, e.g., alien, child runaway, AWOL;
• stigmatized behavior and/or diseases, e.g., HIV, alcoholism, drug abuse, mental illness;
• embarrassing behavior, e.g., immoral behavior, sexual behavior;
• discriminatory condition, e.g., employability, reputation, financial standing.

Listed below are links to helpful pages on the Office for Human Research Protection (OHRP) web site and the National Institutes of Health (NIH) web site. The pages provide information about acquiring a Certificate of Confidentiality.

http://grants2.nih.gov/grants/policy/coc/
http://grants.nih.gov/grants/policy/coc/contacts.htm
http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm

1. The research is minimal risk and involves no procedures for which written consent is usually required; or
2. The only record linking the subject and the research would be the consent document and the principal risk of the research is the risk of breach of confidentiality.

Subjects enrolling in a study under this type of waiver must be provided with the elements of consent required by the regulations and subjects must consent to participate.

The Board will need to review the information that is provided to subjects to obtain consent to ensure that the required elements of consent are included in the consent discussion. Investigators requesting a waiver of documentation of consent must submit a written statement or script of this information for the Board’s review. A template “Information Sheet” is available on the Download Forms page.

If plans for obtaining consent from the pregnant partner (or a request for a consent waiver) are not submitted at initial review, the Board may approve the research, but send a letter reminding the investigator and sponsor that pregnant partners and their infants cannot be followed -up until WIRB approves a consent plan for them. Please note that no action is necessary until such time as a pregnancy occurs.

The letter will be accompanied by a sample consent form template sites and sponsors may choose to use as a starting point for drafting a consent form for the pregnant partner. The template consent form is available on the Download Forms page. The template consent form cannot be used without WIRB approval.

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• Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
• Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand, or foot, loss of hearing, paralysis or stroke.

“…During the clinical investigation of the drug, it may be appropriate to use the drug in the treatment of patients not in the clinical trials, in accordance with a treatment protocol or treatment IND. The purpose of this section is to facilitate the availability of promising new drugs to desperately ill patients as early in the drug development process as possible, before general marketing begins, and to obtain additional data on the drug’s safety and effectiveness…Treatment use of an investigational drug is conditioned on the sponsor and investigators complying with the safeguards of the IND process, including the regulations governing informed consent (21 CFR part 50) and institutional review boards (21 CFR part 56) and the applicable provisions of part 312, including distribution of the drug through qualified experts, maintenance of adequate manufacturing facilities, and submission of IND safety reports.”

Please Note: Regulations require that an emergency use of a test article be reported to the IRB within 5 working days (21 CFR 56.104(c)). Consequently, you must report an emergency use to WIRB within 5 working days of its occurrence, even if you communicated with WIRB prior to the emergency use.