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Does WIRB provide services internationally?

Yes. With experience in more than 70 countries, we can help you meet all the logistical, cultural, and regulatory challenges of international research. We reference local laws, customs, and attitudes to ensure that research is culturally and legally acceptable.

Can WIRB do both IRB and IBC reviews on my clinical trial?

Yes. WIRB can review research involving recombinant DNA for human subject protection (IRB services), researcher, staff, and environmental protection (IBC services), or both.

Other
General
Shared Oversight
Initial Review
Legally Authorized Rep.
Post-Approval
Consent/Consent Forms
Recruitment Materials

Can I submit paperwork before choosing a PI?

Yes. WIRB can assist sponsors and CROs during the planning stages of a multi-center study by pre-reviewing the protocol and subject materials, including the consent form. Log on to Connexus (https://connexus.wcgclinical.com/) or click on Download Forms to complete the Initial Review Submission Form to request review. The fees for initial review apply.

Is my protocol exempt from review?

WIRB will provide a written opinion that a proposed project is exempt from the requirement for IRB review or that it does not require IRB review because the project does not involve research or does not involve human subjects. Complete the Initial Review Submission Form.

Where do I find re-consent instructions?

WIRB's Certificate of Action (COA) provides re-consent instructions under the area titled Please note the following information:

When submitting items to WIRB for review, is the use of the submission form required?

Yes, submission forms are required for initial review and change of prinicipal investigator requests. Use of our Change in Research submission form is optional, though recommended. Each submission form lists the items required to accompany your request. Log on to Connexus (https://connexus.wcgclinical.com/) for convenient smartform submission or click "Download Forms" to access your desired form.

What is a Principal Investigator (PI)?

The PI is the named person who is responsible, under the regulations, for conduct of the research. WIRB prefers that only one investigator be named for this responsibility (Principal Investigator), but will allow a second person upon request (Co-Principal Investigator). Federal regulations do not recognize Co-Principal Investigators. Therefore, the Board approves the two investigators as if each is THE investigator and holds each individually responsible for the conduct of the entire study.

If there are multiple sub-investigators and/or sites, WIRB may require an explanation as to how the PI will personally conduct or oversee the research, as required under 21 CFR 50.3(d), 21 CFR 312.60, and Box 9 of the FDA Form 1572.

How do I submit a change of Principal Investigator (PI)?

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).
In addition to the sponsor authorization of the change, the request should also be accompanied by:

A WIRB initial review submission form completed by the new PI.
Documentation of the new investigator's qualifications to conduct the study (a CV and, when applicable, a professional license).
A request to update the investigator information in the existing consent documents to reflect the new investigator information.
Any other materials the form prompts you to submit.

How will I receive documents from WIRB?

Your documents will be sent by email to the address(es) indicated in the WIRB initial review submission forms.

You can also access your approval documents and other research-related information 24 hours a day via WIRB's web portal called Connexus (https://connexus.wcgclinical.com). Click "LOGIN to WCG Connexus" in the upper right to set up an account.

What is a protocol?

The "protocol" is the written detailed description of the research project.

What is a research study?

The term "study" is used by WIRB to mean the combination of a particular research protocol and investigator.

What is a clinical trial?

The commonly used terms "research trial" and "clinical trial" generally refer to the overall research project at one or more investigator sites. WIRB does not use "trial" in consent forms because of possible misunderstanding by a lay reader.

What is a sponsor?

A sponsor is the company, person, agency, or other party that designs the research, typically funds the research, and bears the sponsor responsibilities under the regulations, but does not actually conduct the investigation.

If there is another IRB involved in my research, what are the options available for WIRB involvement in the oversight?

WIRB can engage in an agreement with another IRB to:
Provide complete dual oversight of research with another IRB, in which both IRBs provide initial and continuing review of all aspects of the research. (Exception: Effective January 2018 for NIH research, only one IRB can oversee the research - with some very narrow exceptions defined by NIH.)

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; or

Assume jurisdiction from an existing institutional IRB for the review of a study or studies.

What are WIRB's requirements for consent form signatures?

1. Subject Signatures The subject must sign and date the consent form [21 CFR 50.27(a); ICH 4.8.8].

WIRB may waive this requirement, when appropriate, under 21 CFR 56.109(c) or when consent is entirely waived under 21 CFR 50.23, 21 CFR 50.24. .

2. Signature of Person Who Conducted the Informed Consent Discussion The person who conducts the informed consent discussion must sign and date the consent form (ICH 4.8.8).

3. Witness Signature WIRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WIRB will include a witness signature block at the request of the investigator or the sponsor. Because WIRB does not require a witness signature, WIRB does not have written procedures identifying who may serve as a witness. The investigator or the sponsor should have written procedures describing who may be a witness and what the witness signature signifies. If a witness signature block is included on the consent form, it must be signed for each consent form, unless the investigator or sponsor written procedures allow otherwise.

Does my study require a Certificate of Confidentiality, and if so, how do I obtain one?

WIRB’s Board requires a Certificate of Confidentiality (CoC) for certain types of research in order to provide the subjects with extra protection of their confidential information as defined in 21 CFR 56.111(a)(7). 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) website and the National Institutes of Health (NIH) website. 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/policy/certconf.html

What is the difference between “Emergency Use” and “Treatment Use,” and how do I determine which situation I have?

Please review the information on this page Expanded Access.

Are we required to obtain the consent of subjects who were originally enrolled as children, but have now reached the age where they can consent for themselves?

Yes. Unless consent has been waived, WIRB requires you to obtain the consent of subjects who reach the age of majority during the research. You may use the current WIRB-approved consent form to obtain their consent, or, if the approved consent form is not appropriate for doing so, you may download the consent addendum and present it, along with the current WIRB approved consent form, to the subject in order to obtain his/her consent.

If you use the addendum, please remove the statement from it regarding authorization to use and disclose information if the consent form signed by the parent/guardian did not include an authorization section.

You do not have to seek WIRB approval of the generic addendum before using it if you use it without alteration (besides removal of the authorization statement if appropriate as outlined above).

Why does WIRB require a corrective action plan with unanticipated problem reports?

Sites often ask why WIRB requires a corrective action plan with reports of unanticipated problems, since the regulations do not specifically require a corrective action plan.

An adverse event or protocol variance is considered to be an unanticipated problem if it suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized. If this is the case, WIRB has an ethical responsibility to ensure a corrective action is proposed that will minimize the risk or at least inform subjects about the increased risk (so that they can make a decision about whether to continue to participate in the research). Possible actions taken to minimize the risk might include (but are not limited to) a change in the inclusion or exclusion criteria, addition of new safety monitoring, a change to the administrative processes at the site, or the addition of information about the increased risk to the consent form.

What is WIRB's policy regarding the Statement of Investigator, form FDA 1572?

Investigators are not required to submit a 1572 to WIRB, even when one is required by the FDA for the research being conducted. The FDA Information Sheet "Frequently Asked Questions - Statement of Investigator (Form FDA 1572)" defines the 1572 as:

An agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic.

The same information sheet goes on to explain that:

The 1572 has two purposes: 1) to provide the sponsor with information about the investigator's qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation, and 2) to inform the investigator of his/her obligations and obtain the investigator's commitment to follow pertinent FDA regulations.

For questions regarding completion of and requirements for a 1572, sites may refer to the guidance issued by FDA here: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf

What do I need to know about WIRB's relocation to Puyallup?

Effective December 6, 2013, WIRB’s offices are located at 1019 39^th Ave SE, Puyallup, WA 98374.

We have prepared an address change notification to subjects for sites to provide to all enrolled subjects. The notification is available on the WIRB web site and is also being sent to sites with change in research and continuing review approval documents.

In existing, approved consent forms, WIRB is replacing its Olympia address with the Puyallup one when revisions are processed.

When WIRB issues a revised consent form, only the substantive issues in the consent form will determine whether the Board directs sites to re-consent all subjects using the revised consent form. The WIRB address change alone does not necessitate formally re-consenting all subjects if they are provided with the notification discussed in point 1 above.

Puyallup [pronounced pew-al-up] is located between Washington’s largest cities -- Olympia, Tacoma and Seattle -- and is within driving distance of several major colleges and universities. Our new, state-of-the-art facility is equipped with the latest technology, to enhance existing processes and improve efficiency.

Our drive for continuous improvement is eclipsed only by our commitment to provide you with the quality and service you deserve. As a client of WIRB, you should expect the gold-standard in ethical review. Should you have any questions, please contact us at 1-800-562-4789. As always, we thank you for your continued business and look forward to serving you in the future.

How does WIRB handle initial review of consent forms from affiliated institutions?

Multi-site protocols previously approved by WIRB:

If you do not require site-specific customization, WIRB will create your site’s informed consent using the WIRB-approved template, as is. When completing the WIRB Initial Review Submission Form in MyConnexus, simply select ”no” when prompted to submit site-specific wording in the consent customization section. WIRB will add your site-specific information included in your submission form, such as investigator name, 24-hour telephone number, and subject payment language, and institution-specific requirements.

If you require customized language, request the WIRB-approved consent template from Client Services at ClientServices@wirb.com. Track (redline) your changes on the WIRB-approved informed consent so WIRB can easily identify your site-specific customizations.

If your institution has language that is chosen by a checklist or other documentation such as cover letters or grants and contracts forms, it must be included with the application to WIRB as usual. WIRB will incorporate this language into the consent form that will be approved for you.

If your institution requires protocol-specific insertion of language to the text of the consent form, such as study visit durations or a listing of which procedures are standard care, clearly mark those changes on a copy of the WIRB-approved consent form. All other standard institution language will be incorporated by WIRB and does not need to be marked on the submitted consent form.
If your institution requires a pre-review of your application that includes a consent form, please contact WIRB to obtain a copy of the previously approved consent form to include for this review. Client Services can be reached by phone at 1-800-562-4789 or by email at ClientServices@wirb.com. The copy of the consent form that you receive will not include the institutional language requirements, but you do not have to incorporate this language yourself, because WIRB will do so as part of its review. If your institutional pre-review has any questions about this, please refer them to WIRB.

Multi-site protocols NOT previously approved by WIRB:

If WIRB has not previously approved the protocol, submit the sponsor’s template as a Microsoft Word compatible file. There is no need to incorporate any institution-required language because WIRB will do so as part of its review, including information from the submission form and any language from a checklist or other documentation such as cover letters or grants and contracts forms.

Single-site protocols:

Submit a consent form as a Microsoft Word compatible file that will be reviewed as new. Please make sure you have reviewed the information on this website on consent forms. You may also request to have WIRB write the consent form (extra fee applies). Please incorporate your institution-required language into the submitted consent form. Please contact your institutional department for the latest version of required language.

If there is another IRB involved in my research, what are the options available for WIRB involvement in the oversight?

WIRB can engage in an agreement with another IRB to:

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) (Exception: Effective January 2018 for NIH research, only one IRB can oversee the research - with some very narrow exceptions defined by NIH.)
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).

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 PI request. The form lists any additional materials items required.

Also posted on the website is a Change in Research Submission Form. Please use this form 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.

How does WIRB handle initial review of consent forms from affiliated institutions?

Can I submit a hand-written submission form?

No. Our submission forms are 'smart' PDF forms that change dynamically based on information you enter in the form.

How should consent forms be submitted?

Consent forms should be submitted in a Microsoft Word compatible format. This includes files with extensions .doc (Word 2003 and earlier), .docx (Word 2007 and later), and .rtf (Rich Text Format, available in most word processing programs). If you have received only a .pdf version from the sponsor, please attempt to get a Word version.

What information is required when submitting advertisements to WIRB for review?

WIRB recommends submitters use the Change in Research Submission Form to submit – the form will prompt you to submit all the appropriate information needed to process your review request without delays. The basic information required includes: investigator name, sponsor name, research protocol number, and the name of the person submitting. Ads must be submitted and approved by WIRB before they are used.

For best results, when submitting subject recruitment materials or other subject materials (diaries, questionnaires, etc.) that have been previously reviewed by WIRB, state in the submission which items have been previously reviewed by WIRB. WIRB support staff will provide the Board with information about the previous Board review, and the previous decision of the Board will be taken into account when the additional materials are reviewed.

If some recruitment will be done on a website, submit the recruitment portions of the website for WIRB review; do not submit the portions of the website that are not intended for subject recruitment.

Ads can be submitted via WIRB's online submission tools, by sending email to ClientServices@wirb.com, or via postal mail or fax.

WIRB requires a copy of ads as they will appear, to allow the Board to review the font size, font style, images, etc.

Advertisements that will be used by some or all participating investigators should be identified as such in the cover letter or submission form. Identifying shared advertisements as such will help ensure consistent review of ad materials for all participating sites.

Should I do anything differently if I am submitting audio and/or video recordings?

To avoid costly re-work, audio or video recordings should be submitted first as a script. When the script is approved by WIRB, it may then be used to make the final recording. The recording should then be submitted with a copy of the WIRB approved script for final review as an audio or video file uploaded via Connexus (can also send hard copy as video tape, audio tape, CD, DVD, etc. - we cannot return hard copy recordings to you -please be sure to retain a copy for use). The audio or video ad is not approved for use until the final recording has been reviewed and approved by WIRB.

Can I make changes to an advertisement without resubmitting to WIRB?

Changes made to an advertisement may alter the effect of the advertisement on potential subjects (changes to pictures, font sizes, font types, etc.). WIRB must review anything that could alter the impact of what was previously reviewed, as required in 21 CFR 56.108(a)(4).

See the the Guide for Researchers for more information about modifications to approved recruitment materials, or contact Client Services via email at clientservices@wirb.com or call 1-800-562-4789.

What if changes are desired in sponsor-approved language in a consent form?

Initial Review:

To request that WIRB consider at the time of initial review wording that differs from the sponsor's template consent form or the consent form already approved by WIRB (approved during WIRB's pre-review or approved for other sites), you have two options: 1) You may rewrite all or some of the consent form yourself and submit the changes clearly marked on the WIRB-approved copy of the consent form (or on the sponsor's template if no WIRB-approved version exists); or 2) You may send a cover letter communicating your concerns, and it will be used in the WIRB review and editing of the consent form.

After Initial Review:

To request changes to consent forms for approved research, WIRB requires a completed Change in Research Submission Form 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 email at ClientServices@wirb.com or by calling 1-800-562-4789.

How do I obtain informed consent from someone who speaks and understands English, but cannot read English?

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.

The definition of impartial witness is provided at ICH 1.26, which states:
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.

WIRB applies this provision of ICH to all research studies.

If an impartial witness signature block is not included on a consent form, and the site encounters a subject who speaks and understands English, but does not read English, please check to see if the protocol allows enrollment of limited or non-readers. If the protocol does not exclude them, download the WIRB standard impartial witness form from the Download Forms page to document the participation of an impartial witness in the consent process for the non-reader.

The impartial witness block may not be used to enroll subjects who speak a language other than English. WIRB requires that non-English speaking subjects sign a translated consent form. See the frequently asked question "How is consent obtained from a non-English speaking subject?" for more information.

Why did WIRB change the consent form?

WIRB makes changes to consent forms to ensure the content complies with our SOPs, is factually correct and conforms to the requirements of institutions and sponsors. In the "redline" version, the superscript numbers and Legend Reasons for Change provide information about why a change was made.

How will I receive documents from WIRB?

If there is another IRB involved in my research, what are the options available for WIRB involvement in the oversight?

WIRB can engage in an agreement with another IRB to:

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) (Exception: Effective January 2018 for NIH research, only one IRB can oversee the research - with some very narrow exceptions defined by NIH.)
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).

What are WIRB's requirements for consent form signatures?

1. Subject Signatures The subject must sign and date the consent form [21 CFR 50.27(a); ICH 4.8.8].

WIRB may waive this requirement, when appropriate, under 21 CFR 56.109(c), or when consent is entirely waived under 21 CFR 50.23, 21 CFR 50.24.

2. Signature of Person Who conducted the Informed Consent Discussion
The person who conducts the informed consent discussion must sign and date the consent form (ICH 4.8.8).

3. Witness Signature
WIRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WIRB will include a witness signature block at the request of the investigator or the sponsor. Because WIRB does not require a witness signature, WIRB does not have written procedures identifying who may serve as a witness. The investigator or the sponsor should have written procedures describing who may be a witness and what the witness signature signifies. If a witness signature block is included on the consent form, it must be signed for each consent form, unless the investigator or sponsor written procedures allow otherwise.

4. Signature of Impartial Witness
If a subject or a legally authorized representative (LAR) is unable to read because of blindness, illiteracy, or some other reason, an impartial witness should be present during the entire consent process, and should sign and date the consent form in compliance with ICH E6 4.8.9. The definition of an impartial witness is provided at ICH E6 1.26. In the absence of designated signature lines, download the WIRB standard impartial witness form from the Download Forms page of www.wirb.com.

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.

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 Action 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

If the subject is unable to assent at all due to incapacity, the person conducting the assent should still sign this block to indicate that an attempt was made to obtain the subject's assent.

8. Signature of Principal Investigator
As of June 19, 2001, WIRB does not require an investigator's signature on the consent form; however, if a consent form is submitted with an investigator signature line, WIRB will not remove it. If an investigator signature line is on the consent form, the investigator or an "equally qualified" sub-investigator must sign the consent form. WIRB does not require that the investigator signature be dated the same as the subject signature.

Why is there a signature block for the person who conducted the consent discussion?

WIRB will automatically include a signature block to be signed by "the person who conducted the informed consent discussion," in compliance with ICH 4.8.8. WIRB does not include a witness signature block unless requested by the site or sponsor.

How do I consent a cognitively impaired subject?

FDA regulation 21 CFR § 50.20 states that:
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 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.”

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 healthcare 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.

What is a legally authorized representative (LAR)?

How is consent obtained from a non-English speaking subject?

WIRB requires that non-English speaking subjects sign the current 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. Fill out and submit the Translation Request Form.

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.

As of June 1, 2010, the California Experimental Subject's Bill of Rights is not included in the approved consent form. However, consent forms continue to contain a reference to it ("If you agree to be in this study, you will receive a signed and dated copy of this consent form and the Experimental Subject's Bill of Rights for your records"), and it continues 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.

Does my study require a Certificate of Confidentiality, and if so, how do I obtain one?

WIRB’s Board requires a Certificate of Confidentiality (CoC) for certain types of research in order to provide the subjects with extra protection of their confidential information as defined in 21 CFR 56.111(a)(7).
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) website and the National Institutes of Health (NIH) website. 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/policy/certconf.html

What is a waiver of documentation of consent and what criteria must my study meet if I request one?

A waiver of documentation of consent is a waiver of the requirement for a signature on a consent form. The regulations allow the Board to approve this type of waiver if: The research is minimal risk and involves no procedures for which written consent is usually required; or

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.

What is WIRB's policy regarding the Statement of Investigator, form FDA 1572?

How do I consent a cognitively impaired subject?

If adult subjects do not have the capacity to consent, WIRB expects that consent will be obtained from a legally authorized representative (LAR), and that the assent of the subject will be obtained to the extent compatible with their capacity. FDA regulation 21 CFR § 50.20 states that:
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 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.”

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 healthcare 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.

What is a legally authorized representative (LAR)?

FDA regulation 21 CFR § 50.20 states that:
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 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.”

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 healthcare 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.

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 form lists what additional documentation may also be required.

Also posted on the website is a Change in Research Submission Form. Please use this form 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.

How do I submit a change of Principal Investigator (PI)?

A WIRB initial review submission form completed by the new PI.
Documentation of the new investigator's qualifications to conduct the study (a CV and, when applicable, a professional license).
A request to update the investigator information in the existing consent documents to reflect the new investigator information.
Any other materials the form prompts you to submit.

Can I submit a hand-written submission form?

No. Our submission forms are 'smart' PDF forms that change dynamically based on information you enter in the form.

How should consent forms be submitted?

What information is required when submitting advertisements to WIRB for review?

How will I be notified of my ad's approval?

Ads are approved in one of two ways: "As Submitted" (no changes) or "As Modified." Board-directed changes are indicated on the ad returned with the Certificate of Action. Beginning in 2019, WIRB will discontinue adding the text “ – as submitted” to items listed on the Certificate of Action that were approved without modification. This will be a phased approach, so some previously reviewed items will continue to indicate “ – as submitted” on COAs.

Ads submitted with the protocol and consent form at the time of initial review will be returned in the initial approval packet. Approved ad(s) will be listed on the Certificate of Action, and show any changes required by WIRB. (Prior to 2013, acceptable audio and video scripts were found "approvable" and stamped as such; "approvable" scripts were not listed on the certificate of approval; currently they are approved, but audio and video materials may not be used until after the audio or video recording has been reviewed by the Board.)

Should I do anything differently if I am submitting audio and/or video recordings?

Can I make changes to an advertisement without resubmitting to WIRB?

Changes made to an advertisement may alter the effect of the advertisement on potential subjects (changes to pictures, font sizes, font types, etc.). WIRB must review anything that could alter the impact of what was previously reviewed, as required in 21 CFR 56.108(a)(4).

See also the Subject Recruitment Materials section of this website for more information about modifications to approved recruitment materials, or contact Client Services via e-mail at ClientServices@wirb.com, or call 1-800-562-4789.

What if changes are desired in sponsor-approved language in a consent form?

Initial Review:

To request that WIRB consider at the time of initial review wording that differs from the sponsor's template consent form or the consent form already approved by WIRB (approved during WIRB's pre-review or approved for other sites), you have two options: 1) You may rewrite all or some of the consent form yourself and submit the changes clearly marked on the WIRB-approved copy of the consent form (or on the sponsor's template if no WIRB-approved version exists), or 2) You may send a cover letter communicating your concerns, and it will be used in the WIRB review and editing of the consent form.

After Initial Review:

To request changes to consent forms for approved research, WIRB requires a completed Change in Research submission form 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.

Why did WIRB change the consent form?

WIRB makes changes to consent forms to to ensure the content complies with our SOPs, is factually correct, and conforms to the requirements of institutions and sponsors. In the "redline" version, the superscript numbers and Legend Reasons for Change provide information about why a change was made.

Why is there a signature block for the person who conducted the consent discussion?

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.

As of June 1, 2010, the California Experimental Subject's Bill of Rights is not included in the approved consent form. However consent forms continue to contain a reference to it ("If you agree to be in this study, you will receive a signed and dated copy of this consent form and the Experimental Subject's Bill of Rights for your records"), and it continues 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.

Are we required to obtain the consent of subjects who were originally enrolled as children, but have now reached the age where they can consent for themselves?

Yes. Unless consent has been waived, WIRB requires you to obtain the consent of subjects who reach the age of majority during the research. You may use the current WIRB-approved consent form to obtain their consent, or, if the approved consent form is not appropriate for doing so, you may download the consent addendum and present it, along with the current WIRB approved consent form, to the subject in order to obtain his/her consent.

If you use the addendum below, please remove the statement from it regarding authorization to use and disclose information if the consent form signed by the parent/guardian did not include an authorization section.

You do not have to seek WIRB approval of the generic addendum before using it if you use it without alteration (besides removal of the authorization statement if appropriate as outlined above).

Why does WIRB require a corrective action plan with unanticipated problem reports?

The PI is unexpectedly no longer able to oversee the study. What do I do?

WIRB must be assured that the investigator can personally oversee the conduct of the research and the protection of human subjects [21 CFR 56.102 (h); for Canadian investigators: Part C Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations (if applicable), Medical Devices Regulations (if applicable)].

As soon as possible, WIRB will need either a study closure request from the site, or a submission of a new PI for the Board’s review. As with any unanticipated research-related event, please submit this information within 10 days of the investigator’s departure from the study.

Provide the following information with your submission:

When did the PI leave this study?
Why did the PI leave this study?
Who has provided oversight in the PI's absence?
Have there been any subject safety concerns during the PI's absence?

What information is required when submitting advertisements to WIRB for review?

How will I be notified of my ad's approval?

Should I do anything differently if I am submitting audio and/or video recordings?

Can I make changes to an advertisement without resubmitting to WIRB?

Changes made to an advertisement may alter the effect of the advertisement on potential subjects (changes to pictures, font sizes, font types, etc.). WIRB must review anything that could alter the impact of what was previously reviewed, as required in 21 CFR 56.108(a)(4).

See also the Subject Recruitment Materials section of this website for more information about modifications to approved recruitment materials, or contact Client Services via e-mail at ClientServices@wirb.com or call 1-800-562-4789.

What are the benefits of CPU services?

CPU Services is pleased to provide:

Specialized Review for your clinical research unit
Accelerated Review Cycle Time
Dedicated Point of Contact
Multiple Meetings Per Week
Authenticated Website

How do I become a CPU Services client?

If you are interested in becoming a CPU Services client, please contact us or call (866) 956-2467. One of our knowledgeable coordinators will assist you throughout the prequalifying process and answer any questions you may have.

What is WIRB’s turnaround time?

Initial CPU review turnaround is 5-7 days, and 1-2 days for changes in research.

What qualifications does my site need?

The following items must be completed prior to submission of research:

The site needs to verify they are a Clinical Pharmacology Unit
A pre-qualifying site visit must be performed (can sometimes be waived by WIRB)
A primary point of contact must be provided
Agreement to use the preapproved CPU Service Consent Form Template

Does CPU Services review more than first-in-human, healthy subject protocols?

Yes, WIRB reviews all types of Clinical Pharmacology Unit research, including Phase 1, bioequivalence/bioavailability, diabetes, oncology, and renal disease research in both healthy and diseased individuals.

Other
For sites
For sponsors and CROs
For review committees

When is IBC review necessary?

The most common triggers for mandatory IBC review include:
1) Funding: If an institution or research sponsor receives funding from the National Institutes of Health (NIH) for research with recombinant or synthetic nucleic acid molecules, all the institution’s or sponsor’s research must comply with the NIH Guidelines, which includes IBC review. Other federal agencies or private sponsors may also require IBC review as a condition of funding.
2) Agent development: If a study agent used in a human gene transfer clinical trial was developed with funding from the NIH, than all trial sites must comply with the NIH Guidelines, which includes IBC review.
3) Local policies or regulations: Universities or health care systems sometimes require IBC review as part of their employee risk reduction strategy. Local or state government regulations may also require IBC review.

Does IBC Services provide “central IBC” review?

No. Unlike the IRB regulations, a single IBC cannot review for a multi-center trial because the NIH Guidelines require local IBC review. The IBC must be registered for each institution conducting recombinant DNA research that is subject to the NIH Guidelines. According to the NIH Guidelines, each local IBC must have at least two unaffiliated local members, who represent the interests of the community. Also, the IBC must include at least one member representing the people who actually handle the recombinant DNA agent (“laboratory technical staff”).

How long does it take for IBC approval?

For institutions currently working with IBC Services, reviews can take as little as 4 to 6 weeks. For new institutions, the process takes an additional couple of weeks. Time to review is highly dependent on the preparedness of the study site and staff, as well as on the time it takes for members of the study staff and institution to complete the documents necessary for IBC review. IBC Services has experience finding workable solutions to the common reasons for delays. Also, IBC Services can help sponsors identify potential sites with previous human gene transfer clinical trial experience and previous experience working with IBC Services.

How can I get started?

Sites: The best first step is to select a point person to contact IBC Services. We can assemble and register your local IBC even before study arrangements are final (see Part A submission form). Then when the research plan is settled, we will help you prepare for successful IBC review (see Part B submission form).
Sponsors: Call us early to discuss your needs and timelines. We can help develop protocols for safe clinical handling of your product, help draft informative and compliant consent forms, and help identify sites that have proven capabilities with human gene transfer clinical trials.

Where are the IBC regulations?

The most important source is the NIH Guidelines for Research Involving Recombinant DNA Molecules”. The NIH Guidelines assign responsibilities to the Institution, the Principal Investigator, and the IBC, but not the sponsor, so that it is important to understand your own compliance obligations. State and local jurisdictions may also regulate research with recombinant DNA or related topics such as disposal of biohazardous waste. Also, some OSHA regulations are particularly relevant to gene transfer research, such as rules about bloodborne pathogens, needle stick prevention, worker protections (immunizations, personal protective equipment), and provisions for occupational health.

What are the sponsor’s responsibilities under the NIH Guidelines?

The NIH Guidelines do not assign particular responsibilities to sponsors. The premise of the NIH Guidelines is that the researchers are responsible for biological safety, so the PI is the regulatory ‘touch point’ for the NIH. Sponsors are regulated mainly by the FDA.The NIH Guidelines do not assign particular responsibilities to sponsors. The premise of the NIH Guidelines is that the researchers and institution sponsoring the research are responsible for biological safety and compliance with the NIH Guidelines. Accordingly, the Principal Investigator and Institution are the regulatory ‘touch point’ for the NIH. Sponsors are regulated mainly by the FDA.

When can we close a study with IBC?

The NIH Guidelines call for the local IBC to determine the scope and duration of IBC oversight, so each local IBC will make its own determination about this typically based on the protocol and the biology of the recombinant DNA product. Considerations may include what is known about the time course of delayed adverse events, the characteristics of the vector or the modified DNA, the population under study, the presence of the product at the research site, etc. For human gene transfer clinical trials, IBC oversight typically extends for one year after the last subject receives the last dose of the recombinant DNA study agent at that specific trial site, but may be longer for certain studies. In most cases IBC oversight The IBC action does not affect ongoing oversight requirements of the IRB, the FDA, and the NIH.

What if the sponsor goes out of business during the follow-up?

The NIH Guidelines, which establish the system of IBC oversight, do not assign any responsibilities to commercial sponsors, so IBC oversight is not dependent on sponsor participation. Under the NIH Guidelines, the Principal Investigator may not modify the research without prospective IBC approval. Accordingly, the principal Investigator remains responsible for conducting the protocol as approved by the IBC. This would include the tests or procedures (such as cancer screening or sample collection) included in the long-term follow-up. The best time for contingency planning is before initiating the research.

“Biosafety Level 2" --what does that mean?

A "biosafety level" describes a set of precautions used to guide safe A "biosafety level" describes a set of precautions used to guide safe handling recombinant DNA agents, including elements of both the physical containment and practices. Most gene transfer products are handled at BSL2 or even BSL 1 (the lower end of the scale, with BSL4 the highest). Any clinical site that handles body fluids should be able to provide BSL2 containment using routine medical precautions, procedures, and equipment. Compared to BSL1, BSL2 controls offer additional protection to the product, the people handling it, and the environment. The biggest differences are more attention to the facilities, training, signage, decontamination, transportation, and disposal of the gene transfer product. Many (but not all) gene transfer products require the use of a biological safety cabinet (BSC) to prepare the product.

How can we find supplies such as eyewashes, approved disinfectants, etc.?

IBC Services can provide you a list of resources. Check also with your usual medical supplies provider. Your IBC roster will typically include at least one person who should be able to suggest reliable suppliers in your area.

What is IBC Services?

IBC Services is a division of WCG Biosafety that focuses on the external administration of Institutional Biosafety Committees (IBCs). The mission of this division is to protect the safety of study subjects, researchers, their communities, and the environment by promoting the safe conduct of recombinant DNA research and compliance with the requirements of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (the NIH Guidelines). IBC Services helps clients establish and staff an IBC for their institution, and register the roster for this IBC with the National Institutes of Health. IBC Services also helps Principal Investigators and members of their staff navigate the biosafety requirements of the NIH Guidelines, and prepare the facilities, practices, and documentation necessary to receive approval for their research from their IBC. Since the year 2000 IBC Services has set up and administered over 600 IBC, and helped Principle Investigators prepare for over 3,000 IBC reviews. Although the majority of these reviews are for human gene transfer clinical trials, IBC Services also has experience providing IBC oversight for bench and animal research with recombinant DNA. Member of our technical and administrative staff offer unparalleled expertise and experience in setting up and administering IBCs for all types of clients, from single investigator clinics to large academic medical centers.

What can a sponsor do to speed local IBC approval?

Site selection makes a big difference. Some prospective sites may lack appropriate space (such as room for a new freezer, or impervious flooring to allow spill clean-up), a key piece of equipment (such as a biosafety cabinet or locking freezer), or a capability (such as an on-site pharmacist if required by protocol). Sites with an NIH-registered IBC and human gene transfer experience typically have a head start.
Be sure the protocol, investigator brochure, and any special handling instructions are complete, up to date, and consistent with each other. Incomplete or contradictory study documents can create confusion and delay.
IBC Services can provide sponsors, institutions, principal investigators, and study staff with a study guide that includes a comprehensive list of instructions to speed local IBC review.

What is an IBC, and what does it do?

The IBC (Institutional Biosafety Committee) is a multidisciplinary group supporting the safe handling of biohazardous materials. Members include at least two people representing the local area. IBC oversight is required for human gene transfer research that is subject to the NIH Guidelines. The NIH Office of Science Policy has a helpful list of questions and answers about IBCs.

How do I become a committee member?

If you are interested in participating on an IBC in your area, please contact us at (360) 252-2850 or ibcs@wirb.com to introduce yourself as a prospective member, and find out what's involved.

How do I review my meeting documents?

We post meeting documents on our secured website. As an IBC Member you will be provided a username and password, as well as any help you need (individual teaching or online video). If you have any difficulties with the website please contact us at (360) 252-2850 or ibcs@wirb.com.

Education
Consultation

Does WIRB offer education or consulting services?

Education and consulting services are available through our parent company WCG. See the WCG website for more information -- http://www.wcgclinical.com/

I received an FDA Form 483. How can WIRB help me?

WCG's experienced professionals can assess the situation and help you develop a corrective action plan and draft a response to the FDA. Consulting services are available through our parent company WCG. See the WCG website for more information -- http://www.wcgclinical.com/

How do I apply for the International Fellows Program?

To apply to WIRB’s International Fellows Program, please complete the application form HERE and send it, along with a letter of interest and current CV to: fellowsprogram@wirb.com

Does WIRB provide IRB services for research in Canada?

Yes. In 2001, WIRB established a Canadian panel. The composition of the Board meets all of the requirements of the Division 5 regulations. Clinical research submitted to WIRB by Canadian investigators is reviewed by this panel, reviews are conducted in accordance with Health Canada's Division 5, the Tri Council Policy Statement, ICH GCP E6, and U.S. CFR Title 21 Parts 50 and 56 and CFR Title 45 Part 46. The Board meets weekly in its office located in Vancouver, BC, and is fully supported by staff at WIRB's headquarters in Puyallup, Washington.

Does WIRB work with local ethics committees?

WIRB can act as the sole IRB in countries where regulations allow, or work with a local IRB or other review committee where it is required.

How does WIRB ensure sensitivity to local laws and cultures?

When WIRB reviews research in other countries, it obtains information on local laws and local attitudes. WIRB may solicit the help of investigators and sponsors in collecting this information. WIRB also utilizes Board members from the WIRB International Fellows Program to provide local research context if reviewing research within the Fellows' respective countries.

Other
Before enrolling a child
Before joining a study
Why people join research studies
Risks and benefits of research
Responsibilities and rights

What is an IRB and what does it have to do with research?

Before most research studies can start, they must be approved by a committee, usually called an "institutional review board" or "IRB". IRBs are made up of scientists, doctors, non-scientists, and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form for the research to make sure that it is accurate.

What is the difference between medical care and research participation?

When people see their regular doctor for medical care, they are patients. What a doctor does for his or her patient depends on what will be best for the patient. When a person participates in a research study as a subject, the principal investigator must follow the study protocol and provide only the medical care that is specified in the protocol. Consequently the tests and medicines given to the subject may be different than the doctor would give to his or her patient.

Do I have to pay for any of the drugs or procedures in a research study?

You or your insurance company may be responsible for some or all of the costs of the tests and procedures that will be done during the study. Sometimes insurance companies will not pay for medical care that is given as part of a research study, so you may be responsible for those costs. Insurance companies may also not pay for complications or injuries arising from your participation in research.

Will I be paid to participate in a research study?

Sometimes subjects are paid to participate in a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for subjects to come in for the visits and to have procedures performed. Therefore, the payment will often cover costs like parking and babysitting. Research studies for healthy people generally pay more, because these subjects have no medical problem and may have little reason to join the study.

What do I have to do if I join a research study?

As a participant in a research study you will have responsibilities. For example, you will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study-related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting, and time off work.

Where can I find some information about enrolling my child in research?

We suggest that you review the information available on http://www.childrenandclinicalstudies.org/ It is an excellent website devoted to research with children and the concerns parents have about allowing

What is an IRB and what does it have to do with research?

Before most research studies can start, they must be approved by a committee, usually called an "institutional review board," or "IRB." IRBs are made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form for the research to make sure that it is accurate. If it approves the research, the IRB continues to review the ongoing research after it starts. It is important to understand that IRB approval does not mean that a research project is safe or that it is right for you. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to people like you for your consideration. However, you need to carefully look at the details of the research and decide whether it is right for you.

What is research?

Research is an organized way to learn more about almost anything. Research is done in many areas, such as engineering, basic science, psychology, and medicine. When research involves people as subjects, it is called human subject research or clinical research. This website focuses on medical research involving human subjects. Medical research is done to learn more about a drug, a medical device, a medical procedure, or a particular condition or behavior. Some of the terms used to refer to medical research are: Research Study, Clinical Research, Research Trial, Clinical Trial or Experimental Study. Whatever it is called, the goal of medical research is to find better ways to treat conditions, improve health or cure diseases for future patients who have a particular health problem. A research study is done to try and answer a question. The question varies from study to study. The research protocol (study plan) clearly states the question to be asked and discusses all of the tests and procedures that will be done during the research study. The U.S. government usually requires that, before a drug or a device can be sold in the U.S., research studies must be done and the results must show that it is relatively safe and effective for its intended use in humans. If you decide to enter a research study, be sure you know what question the research is trying to answer. More information about research is available on AAHRPP's website. AAHRPP is an organization that accredits high-quality human research protection programs.

What is a sponsor?

Research is planned and initiated by a sponsor. The sponsor may be a government agency like the National Institutes of Health (NIH), a pharmaceutical or device company, a public institution like a University or Medical College, or an individual person.

What is a protocol?

The protocol is the "blueprint" for how the study will be conducted. All the details of the study are described in the protocol. The principal investigator and other research staff must follow the protocol. If the protocol is not followed, the results of the research study may not be useful enough to answer the questions the research is trying to answer.

What is a Principal Investigator (PI)?

The principal investigator is the person responsible for conducting a research project at one or more locations. The principal investigator is usually a medical doctor. Your own physician may be the principal investigator for a research study or the principal investigator could be a physician who only conducts research studies.

What is the difference between medical care and research participation?

The requirement in research to follow a protocol is what makes a research study different from the medical care patients receive from their personal doctor. When people are in research studies they are subjects. When people see their regular doctor for medical care, they are patients. For a patient, the treating doctor uses his or her clinical judgment to do what is best for each patient. A patient may be started on one course of treatment, then switched to another treatment if the doctor determines that the patient is not improving, or is experiencing side effects. What a doctor does for his or her patient depends on what will be best for the patient. On the other hand, when a person participates in a research study as a subject, the principal investigator must follow the study protocol and provide only the medical care that is specified in the protocol. Consequently the tests and medicines given to the subject may be different than the doctor would give to his or her patient. There are several things commonly done in research studies that are not done in regular medical care, such as randomization, blinding, and use of placebo. It is important to know and remember that there is a difference between being a patient and being a research subject.

What is randomization?

In many research studies subjects are assigned to different groups. The subjects in the different groups may receive different doses of drugs, or different drugs, or different devices or other medical procedures. Many times the assignment to a group is made randomly (like drawing a number from a hat). This means that neither the subject nor the investigator chooses which group the subject is placed in. Randomly assigning subjects to groups helps ensure that the results from the study are more accurate.

What is blinding?

Research often uses a technique called "blinding." Blinding can either be single blinding or double blinding. In double blinding, neither the subject nor the investigator knows which drug or procedure the subject will receive. In single blinding, only one person does not know, either the subject or the investigator. Blinding is done to help eliminate the possibility of bias by the investigator and or the subject, and to help the research results be accurate. There are several ways that a study can be blinded. One common way to blind a study is to use a placebo.

What is a placebo?

A placebo looks like a drug but contains no active medicine. In studies that use placebo, all the participants in the research receive drugs that look exactly the same, but all the drugs do not have the same ingredients. Researchers compare the information about subjects receiving the active drug to the information about subjects who receive the placebo. Placebos help ensure that research results are accurate. Placebos are not just pills. Sometimes placebos are used in device studies or studies of medical procedures. In these cases, the placebo may be a device that doesn't work, or a fake surgery where a cut is made, but no surgery is done. The consent form will describe whether the study involves a placebo, so you will know if there is a chance that you will get a placebo.

What is a conflict of interest?

Sometimes a principal investigator or sub investigator may have a conflict of interest. Conflicts of interest can take many forms. The most common conflict of interest arises when a doctor who provides you with medical care is also acting as the researcher overseeing your participation in the research study. In this case, there can be a conflict in his or her duty to make medical decisions in your best interest and his or her duty to follow the research protocol.

Another common type of conflict of interest is financial. For example, the principal investigator might own stock in the sponsoring company, be a paid consultant for the sponsoring company, receive speaking fees from the sponsoring company, or be paid by the sponsoring company to conduct the research. The investigator may hold a patent on the drug or device being studied and stand to benefit if the drug or device is approved for general use. You should feel free to ask if either the principal investigator or research staff has a conflict of interest. If the principal investigator or any of the research staff do have a conflict of interest, discuss how they intend to manage that conflict. Only enter the study if you are satisfied with the safeguards that have been put in place to deal with the potential conflict.

Do I have to pay for any of the drugs or procedures in a research study?

You may be expected to pay for some or all of the tests and procedures that will be done during the study. It is different in each study. Sometimes everything is paid for in a research study, and sometimes you or your insurance will be responsible for all of the costs. Also, be aware that sometimes insurance companies will not pay for medical care that is given as part of a research study, so you may be responsible for those costs. Insurance companies may also not pay for complications or injuries arising from your participation in research. Find out what you or your insurance will be billed before you agree to be in a research study. You may also want to contact your insurance company, although it is sometimes difficult to get them to tell you what they will pay for.

Will I be paid to participate in a research study?

Sometimes subjects are paid to participate in a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for subjects to come in for the extra visits and to have additional procedures performed. Therefore, the payment will often cover costs like parking and babysitting. Research studies for healthy people generally pay more, as these subjects have no medical problem and may have little other reason to join the study.

What is the consent form?

Before you enter a research study, you will be given a document called a consent form. Read the form carefully. It should tell you what you need to know in order to decide whether or not to enter the study. For example the consent form should tell you:

Why the study is being done,
How long your participation will last
The potential benefits to you
The potential risks to you
The standard medical options for your condition
If there is payment for participation
The plans to deal with research related injuries
Who will receive information about you from the study

Why do people join research studies?

There are many reasons why a person may choose to be in a research study. If you are considering joining a research study, you should think about what your reasons and goals are for joining and discuss them with friends, family, a trusted health care provider and with the principal investigator or other study personnel. Talking with these people should help you determine if your reason(s) for joining the study agrees with what may happen as a result of your participation and the question the research is trying to answer. The following are examples of reasons why people join research studies:

Some healthy people decide to join a study because they want to help in developing a cure for a particular disease.
Some people decide to join a research study because they have a disease or condition and they want to help find a cure.
Some people decide to join because they have a disease or condition that has not responded to any of the medications available to treat the condition.
Some people decide to join because they have a very advanced stage of disease and no treatment option is available.
Some people decide to join because they have a disease or condition and they have had bad reactions to the available treatments and they are looking for something with fewer side effects.
Some people decide to join a study because they want the money that is paid to subjects.

Whatever your reason, you need to know that there can never be any guarantee given to you that the research drug, device or procedure will work for you or will ever work well enough to be approved for general use. A doctor may tell you about a research study because he or she thinks you may meet the requirements for enrolling. Just because a research study is suggested to you does not mean that you have to join it.

You can find more information about research participation and deciding whether to participate here:

AAHRPP's website: AAHRPP is an organization that accredits high-quality human research protection programs.
OHRP's website: OHRP is the division of the US Department of Health and Human Services dealing with human research protections.

Are there risks in research?

Joining a research study will usually involve risks. Those risks vary from study to study. You should understand what risks are anticipated in the particular study you are considering and remember that there can always be unanticipated risks for research subjects. The risks should be listed in the consent form. Ask research staff to explain any risks that you do not understand.

Will I benefit if I participate in research?

Sometimes the person (subject) who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving benefit varies from study to study, just like the risks. It is important to remember that the main goal of research is to collect information that may help future patients, not the subject participating in the research study. You should always ask questions and keep asking until you understand how the research study is different from the treatment you would get outside of the research study.

What do I have to do if I join a research study?

As a participant in a research study you will have responsibilities too. For example, you will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting and time off work.

What are my rights as a research subject?

You have several rights as a research subject:

You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits.
If you decide to participate, you have the right to quit at any time. Again, there will be no penalty or loss of benefits.
You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your main source of information about the research study is usually the consent form.
You have the right to ask questions about the research study.
You have the right to get a copy of the consent form.
You do not waive any of your legal rights by joining a research study or signing a consent form.

Deciding to be in a research study is an important decision and requires that you understand what your expectations are. You should talk about your expectations with the study staff before you agree to be in a research study.

If you are looking for more resources to learn about research in general, here is a link to AAHRPP's website. AAHRPP is an organization that accredits high-quality human research protection programs.

Who can I contact with questions or concerns?

If you are in a research study reviewed by the Western IRB (WIRB), the consent form includes information about who you can contact.
If you have a medical emergency, please call your local emergency number, such as 911.
For specific questions about the study or to make appointments, please call the study staff listed in the consent form.
You can call a subject representative at WIRB if you have concerns or complaints you would like to talk about with someone who is not working on the study. If you have a study consent form, please have it available during the call. Click here for the WIRB contact page.
You can also call a subject representative at WIRB if you have general questions, concerns, or comments about being in studies, or if you have questions about the rights of people in studies. Click here for the WIRB contact page.

Where can I find out more information about working at WIRB?

Please review the information on our parent company's website - WCGClinical - here: https://www.wcgclinical.com/about/careers/.