Frequently Asked Questions

How do I become a CPU Services client?

If you are interested in becoming a CPU Services client, please contact us by e-mail 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 are the benefits of CPU services through WCG IRB?

CPU Services provide:

• Specialized Review for your Clinical Research Unit
• Accelerated Review Cycle Time
• Dedicated Point of Contact
• Multiple Meetings Per Week
• Authenticated Website

What is WCG IRB’s CPU review 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 primary point of contact must be provided
• Agreement to use the preapproved CPU Service Consent Form Template

Can I submit a hand-written submission form?

WCG IRB does not accept hand-written initial review submission forms. Because our initial review submission form is a dynamic Smart Form that changes based on your responses to questions in it, you must complete the smart form using Adobe (either the free reader or the full Adobe acrobat software). You may contact our Client Care Team at 1-800-562-4789 or clientcare@wcgirb.com for help using the electronic copies of the submission form or the smart form.

Can I submit my study before choosing a PI?

Yes. WCG IRB can assist sponsors and CROs during the planning stages of a multi-center study by pre-reviewing the protocol and participant materials, including the consent form. Log on to connexus.wcgclinical.com or click on Forms to complete the Initial Review Submission Form to request review. The fees for initial review apply.

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

WCG IRB’s Board requires a CoC for certain types of research to provide the participants 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 participant 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.

• https://grants.nih.gov/policy/humansubjects/coc.htm
• https://www.hhs.gov/ohrp/regulations-and-policy/guidance/certificates-of-confidentiality/index.html

How do I consent a cognitively impaired subject?

You cannot enroll participants who do not have the capacity to consent unless inclusion of such adults is noted on your Certificate of Action.

If an adult participant is not capable to consent to participate in a study, WCG IRB requires that a legally authorized representative consent for the participant and in some cases requires participants to assent to taking part in the research. 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. For questions regarding state and local law, contact a healthcare attorney admitted to the bar in that state. Changes in state and local law may occur frequently. Therefore, legal counsel should always be consulted to determine the current state of applicable law.

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, WCG IRB 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 WCG IRB. (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?

To avoid costly re-work, audio or video recordings should be submitted first as a script. When the script is approved by WCG IRB, it may then be used to make the final recording. The recording should then be submitted with a copy of the WCG IRB 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 WCG IRB.

Can I make changes to an advertisement without resubmitting to WCG IRB?

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

See the Guide for Researchers for more information about modifications to approved recruitment materials, or contact our Client Care Team via email at clientcare@wcgirb.com or call 1-800-562-4789.

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

Yes. Unless consent has been waived, WCG IRB requires you to obtain the consent of participants who reach the age of majority during the research. You may use the current WCG IRB-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 WCG IRB approved consent form, to the participant 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 WCG IRB 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).

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

Sometimes potential participants speak and understand English, but cannot read due to blindness, illiteracy, or some other reason. These individuals may still participate in a research study if the protocol has not excluded or limited 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.”

WCG IRB 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 participant 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 WCG IRB 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 participants who speak a language other than English. WCG IRB requires that non-English speaking participants sign a translated consent form. See the frequently asked question “How is consent obtained from a non-English speaking participant?” for more information.

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

Multi-site protocols previously approved by WCG IRB: 
If you do not require site-specific customization, WCG IRB will create your site’s informed consent using the WCG IRB-approved template, as is. WCG IRB will add your site-specific information included in your submission form, such as investigator name, 24-hour telephone number, and participant payment language, and institution-specific requirements.

If you require customized language, request the WCG IRB-approved consent template from Client Care at clientcare@wcgirb.com. Track (redline) your changes on the WCG IRB-approved informed consent so WCG IRB 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 WCG IRB as usual. WCG IRB 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 WCG IRB-approved consent form. All other standard institution language will be incorporated by WCG IRB 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 WCG IRB to obtain a copy of the previously approved consent form to include for this review. Client Care can be reached by phone at 1-800-562-4789 or by email at clientcare@wcgirb.com.

Multi-site protocols NOT previously approved by WCG IRB:
If WCG IRB 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 WCG IRB 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 WCG IRB 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.

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

WCG IRB requires that non-English speaking participants sign the current WCG IRB-approved translated consent form. An ad hoc oral translation of the consent form is not acceptable. WCG IRB’s Translations department can arrange to have a WCG IRB-approved consent form or participant material translated into any language, or the site/sponsor can submit to WCG IRB a translated document along with a signed translator certification statement for verification and approval. Fill out and submit the Translation Request 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 convert to a Word version.

What are WCG IRB’s requirements for consent form signatures?

1. Subject Signatures
The subject must sign and date the consent form [21 CFR 50.27(a); 45 CFR 46.117(a), ICH 4.8.8]. WCG IRB may waive this requirement, when appropriate, under some circumstances.

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
WCG IRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WCG IRB will include a witness signature block at the request of the investigator or the sponsor. Because WCG IRB does not require a witness signature, WCG IRB 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 participant 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 WCG IRB standard impartial witness form from the Download Forms page.

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 participants who are not legally competent, the consent form will include a signature block for an LAR. If an adult participant is not legally competent, an LAR must participate in the consent process, agree to the enrollment of the participant in the research, and sign the consent form. If the research allows the enrollment of adult participants who are legally competent and participants 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 participant is legally competent. The LAR signature block will only be signed when the participant is not legally competent.

6. Assent of Children  
When research includes children, WCG IRB 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, WCG IRB 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. WCG IRB 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 WCG IRB consent form will include instructions for the documentation of assent. The WCG IRB Certificate of Action will note that assent is required.

7. Assent of Adults Incapable of Consent
When research includes legally cognitively impaired adults, WCG IRB will determine whether the assent of the cognitively impaired adults is required. ICH 4.8.12 requires that when a research study includes participants 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, WCG IRB generally includes the following signature block to document that assent was obtained by a representative of the study:

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

8. Signature of Person Conducting Assent Discussion
If the participant 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 participant’s assent.

9. Signature of Principal Investigator  
WCG IRB does not require an investigator’s signature on the consent form; however, if a consent form is submitted with an investigator signature line, WCG IRB 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. WCG IRB does not require that the investigator signature be dated the same as the participant signature.

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

Initial Review:
To request that WCG IRB consider at the time of initial review wording that differs from the sponsor’s template consent form or the consent form already approved by WCG IRB (approved during WCG IRB’s pre-review or approved for other sites), you may rewrite all or some of the consent form yourself and submit the changes clearly marked on the WCG IRB-approved copy of the consent form (or on the sponsor’s template if no WCG IRB-approved version exists).

After Initial Review:
To request changes to consent forms for approved research, WCG IRB requires a completed Change in Research Submission Form and a copy of the current WCG IRB-approved consent form with proposed changes clearly marked.

Proposed new changes may be submitted on a copy of the current WCG IRB-approved consent form with new changes tracked in redlined format.

For more information on submitting consent form changes, please contact Client Care via email clientcare@wcgirb.com or by calling 1-800-562-4789.

What if I disagree with the Board’s re-consent instructions?

If you disagree with the Board’s re-consent instructions, you may PROMPTLY contact WCG IRB and ask for a reconsideration; however, we advise you not to delay complying with the Board’s instructions.

What if I received two changes to the consent form recently and each accompanying Certificate of Action provided different re-consenting instructions?

The Board expects you to apply the more strict of the two sets of instructions. For example, if the first consent form change included updated risk information and was accompanied by instructions to re-consent all participants, and the subsequent consent form change was the addition of a new site and the Board directed that the revised consent form only be presented to new participants, the site is still expected to provide the updated risk information to all participants using the most current version of the consent form.

What if the Board didn’t require all participants be re-consented, but the site would like to re-consent all participants?

If the site is not required by the Board to re-consent all participants, the site is still free to do so.

What is a legally authorized representative (LAR)?

FDA regulation 21 CFR § 50.20 states that: “No investigator may involve a human being as a participant in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the participant or the participant’s legally authorized representative.”

If an adult participant is not medically capable and/or legally competent to consent to participate in a research study, the federal regulations require that a legally authorized representative consent for the participant. 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 participant to the participant’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 participant is medically incapable and/or legally incompetent, then a legally authorized representative, as determined under state or local law, must consent on the participant’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 participant and the applicability of local law to an individual participant’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.

Where do I find re-consent instructions?

WCG IRB’s Certificate of Action (COA) provides re-consent instructions under the area titled

Please note the following information:

Why did WCG IRB change the consent form?

WCG IRB 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.

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

WCG IRB 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. WCG IRB does not include a witness signature block unless requested by the site or sponsor.

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 WCG IRB initial review submission form completed by the new PI.
• Documentation of the new investigator’s qualifications to conduct the research 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.

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

WCG IRB 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, WCG IRB 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 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.

When is IBC review necessary?

IBC review is required for all non-exempt research subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids, which includes a broad array of nonclinical activities, as well as many clinical trials. Most clinical trials involving any product that is genetically modified or that contains artificially manipulated DNA or RNA are subject to the NIH Guidelines. The requirement for IBC review can also depend on the history of NIH funding involved in product development, clinical trial conduct, or other research at the clinical trial site.

Does IBC Services provide “central IBC” review?

WCG IRB provides “centrally-administered” IBC reviews. NIH Guidelines require that each research site must have its own IBC, and each IBC roster must include community members who live near that research site.   Since the year 2000, WCG IRB has registered over 750 individual IBCs with the NIH. Our current IBC network encompasses over 320 sites with active research programs, including small clinics, community hospitals, and major academic medical centers.

How long does it take for IBC approval?

For sites that are in network, the turnaround time from submission to approval is 1-3 weeks when the location and procedures are pre-approved. For new locations and procedures, the time to approval is 4-6 weeks.

Where are the IBC regulations?

https://osp.od.nih.gov/biotechnology/nih-guidelines/

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 by email: 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 with 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.

Can WCG IRB conduct both IRB and IBC reviews on my clinical trial?

Yes. WCG IRB can review research involving recombinant DNA for human subject protection, researcher, staff, and environmental protection, or both.

Does WCG IRB provide services internationally?

For research conducted outside North America, WCG IRB is happy to provide US review in conjunction with a local IRB when required for funding or regulatory reasons. Other cases can be considered on an individual basis.

We do not provide IRB review of research in other countries where there is not a local IRB. This includes research for which it is unclear if local regulations require IRB review, such as stem cell research, device research, tissue collection studies, and questionnaires and surveys.

Does WCG IRB provide IRB services for research in Canada?

Our Canadian Board — located in Vancouver, British Columbia — provides comprehensive review services for clinical studies conducted in Canada.

In compliance with Canadian regulations, a majority of IRB members on our Canadian board are Canadian citizens or permanent residents. Their reviews are conducted in accordance with Division 5 regulations of Health Canada, the Tri-Council Policy Statement, International Conference on Harmonization (ICH) Guidance for Industry – E6 Good Clinical Practice: Consolidated Guideline, and U.S. CFR Title 21 Parts 50 and 56 and CFR Title 45 Part 46.

How will my study team communicate with WCG IRB?

WCG IRB works intimately with the appropriate institution study team members to ensure workflow efficiency throughout the review process. From outlining submission requirements to walking through informed consent revisions- our teams remain in constant touch with your organization. Furthermore, your institution will have access to WCG IRB’s online document management solution, Connexus, to submit, track, and view recently submitted materials to WCG IRB.

How do I register for Connexus?

To register for Connexus please click here.

Is WCG IRB registered with the Office of Human Research Protections and FDA?

Yes. WCG IRB’s IRB registration number with OHRP and FDA is: IRB00000533. Similarly, our parent organization number is: IORG0000432.

What should I expect if I need translated consent forms that have been customized to my institution?

After you submit your translation request to WCG IRB, we will coordinate with our partners to produce translated versions of the currently approved English consent forms. English versions of the informed consent documents are reviewed and sent separately from the translated informed consents. Therefore, the translated documents will be received subsequent to the English documents, and will incur an additional translation fee.

Can our institution use WCG IRB to review some of our research studies, while maintaining local oversight for other studies?

Yes. After discussions between WCG IRB and your institutional representatives, a program can be customized to fit the specific needs of your institution. This may allow for a subset of studies to be reviewed by WCG IRB (eg, Industry Sponsored studies) or may allow WCG IRB to review research at specific sites within your institution (ie, your outpatient research facility).

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 WCG IRB initial review submission form completed by the new PI.
• Documentation of the new investigator’s qualifications to conduct the research 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.

What is WCG IRB’s policy regarding the Statement of Investigator, form FDA 1572?

Investigators are not required to submit a 1572 to WCG IRB, even when one is required by the FDA for the research being conducted.

How should consent forms be submitted to WCG IRB?

Consent forms should be submitted to WCG IRB in a Microsoft Word compatible format. This includes files with extensions .doc,.docx, and .rtf. If you have received only a .pdf version from the sponsor, please attempt to get a Word version. Contact Client Services if you need any assistance when submitting your documents in this format.

What is a Legally Authorized Representative (LAR)?

FDA regulation 21 CFR § 50.20 states that: “No investigator may involve a human being as a participant in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the participant or the participant’s legally authorized representative.”

If an adult participant is not medically capable and/or legally competent to consent to participate in a research study, the federal regulations require that a legally authorized representative consent for the participant. 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 participant to the participant’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 participant is medically incapable and/or legally incompetent, then a legally authorized representative, as determined under state or local law, must consent on the participant’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 participant and the applicability of local law to an individual participant’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.

How will my study team communicate with WCG IRB?

WCG IRB works intimately with the appropriate institution study team members to ensure workflow efficiency throughout the review process. From outlining submission requirements to walking through informed consent revisions- our teams remain in constant touch with your organization. Furthermore, your institution will have access to WCG IRB’s online document management solution, Connexus, to submit, track, and view recently submitted materials to WCG IRB.

How do I register for Connexus?

To register for Connexus please click here.

Is WCG IRB registered with the Office of Human Research Protections and FDA?

Yes. WCG IRB’s IRB registration number with OHRP and FDA is: IRB0000053. Similarly, our parent organization number is: IORG0000432.

What should I expect if I need translated consent forms that have been customized to my institution?

After you submit your translation request to WCG IRB, we will coordinate with our partners to produce translated versions of the currently approved English consent forms. English versions of the informed consent documents are reviewed and sent separately from the translated informed consents. Therefore, the translated documents will be received subsequent to the English documents, and will incur an additional translation fee.

Can our institution use WCG IRB to review some of our research studies, while maintaining local oversight for other studies?

Yes. After discussions between WCG IRB and your institutional representatives, a program can be customized to fit the specific needs of your institution. This may allow for a subset of studies to be reviewed by WCG IRB (eg, Industry Sponsored studies) or may allow WCG IRB to review research at specific sites within your institution (ie, your outpatient research facility).

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 WCG IRB initial review submission form completed by the new PI.
• Documentation of the new investigator’s qualifications to conduct the research 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.

What is WCG IRB’s policy regarding the Statement of Investigator, form FDA 1572?

Investigators are not required to submit a 1572 to WCG IRB, even when one is required by the FDA for the research being conducted.

How should consent forms be submitted to WCG IRB?

Consent forms should be submitted to WCG IRB in a Microsoft Word compatible format. This includes files with extensions .doc,.docx, and .rtf. If you have received only a .pdf version from the sponsor, please attempt to get a Word version. Contact Client Services if you need any assistance when submitting your documents in this format.

What is a Legally Authorized Representative (LAR)?

FDA regulation 21 CFR § 50.20 states that: “No investigator may involve a human being as a participant in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the participant or the participant’s legally authorized representative.”

If an adult participant is not medically capable and/or legally competent to consent to participate in a research study, the federal regulations require that a legally authorized representative consent for the participant. 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 participant to the participant’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 participant is medically incapable and/or legally incompetent, then a legally authorized representative, as determined under state or local law, must consent on the participant’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 participant and the applicability of local law to an individual participant’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.

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 participants. The risks should be listed in the consent form. Ask research staff to explain any risks that you do not understand.

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 a research 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.

What are my rights as a research participant?

You have several rights as a research participant: 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 helpful information from CenterWatch:  https://www.centerwatch.com/clinical-trials/volunteering.aspx/

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.

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.

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 participants receiving the active drug to the information about participants 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 research study involves a placebo, so you will know if there is a chance that you will get a placebo.

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 a protocol?

The protocol is the “blueprint” for how the research 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 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 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 blinding?

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

What is randomization?

In many research studies participants are assigned to different groups. The participants 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 participant nor the investigator chooses which group the participant is placed in. Randomly assigning participants to groups helps ensure that the results from the research study are more accurate.

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 participants, it is called human participant research or clinical research. This website focuses on medical research involving human participants. 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 the CenterWatch website: https://www.centerwatch.com/clinical-trials/overview.aspx/

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 research 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

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 participants. 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 participant, 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 participant 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 participant.

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

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

Who can I contact with questions or concerns?

If you are in a research study reviewed by the WCG IRB, 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 participant representative at WCG IRB 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 WCG IRB contact page.

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 participants.

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: https://www.centerwatch.com/clinical-trials/volunteering.aspx/

And here: www.hhs.gov/ohrp/education-and-outreach/about-research-participation/informational-videos/index.html. OHRP is the division of the US Department of Health and Human Services dealing with human research protections.

Will I be paid to participate in a research study?

Sometimes participants are paid to be part of a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for participants 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 participants have no medical problem and may have little other reason to join the study.

Will I benefit if I participate in research?

Sometimes the person (participant) 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 participant 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 is a principal investigator (PI)?

The PI is the named person who is responsible, under the regulations, for conduct of the research. WCG IRB 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 research study.

If there are multiple sub-investigators and/or sites, WCG IRB 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.

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 WCG IRB to mean the combination of a particular research protocol and investigator.

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.