Panelist Privacy Notice

General Terms & Conditions

Validated Claim Support (VCS) is committed to protecting your privacy. We use your personal information primarily to:

Administer your participation in our panel database.
Contact you regarding potential or active clinical studies. You can unsubscribe from this communication at any time.

By submitting information through any of VCS’s electronic collection forms or systems, you consent to the collection, storage, and use of your personal information as described in this Notice.

Personally Identifiable Information (PII), Health Insurance Portability Act (HIPAA), and Personal Records Data Retention Policy

VCS is committed to protecting the privacy and confidentiality of the Personally Identifiable Information (PII) and Protected Health Information (PHI) that you provide. This Privacy Notice describes how your personal information may be used and disclosed by VCS, and how you can obtain access to this information. Please carefully review it.

PII and PHI include personal information such as demographic details, information that may individually identify you or information about your lifestyle, as well as your physical or mental health condition as it relates to consumer-related product testing.

VCS is required to abide by the terms of this notice as an extension of research, development and manufacturing in the personal care industry. We reserve the right to change the terms of this notice at any time, and new notices will be effective for PHI collected before their implementation. If this Privacy Notice is updated, you will receive an email with a link to the revised notice on our website.

You may contact our Privacy Security Officers to request a copy, or you can ask for one at the time of your following appointment.

Uses and Disclosures of Protected Health Information

We may contact you by phone, email, or text message regarding appointments, study eligibility, scheduling, compensation, or study follow-up activities. We may also identify you by name when checking you in or calling you for your appointment.

We may also use or disclose your PHI as necessary to operate our business and conduct clinical research activities. These uses may include study recruitment and eligibility screening, payment/compensation processing, operational and administrative purposes, quality assurance, staff training, compliance audits, legal and financial auditing, insurance, and other administrative functions required to support our research operations.

We may also share your PHI with third-party business associates that conduct a variety of activities on our behalf (e.g., IT Administrator, laboratory, payment processing). Whenever an arrangement between our office and a business associate involves the use or disclosure of your PHI, we will have a written contract that contains terms that will protect the privacy of your PHI.

We may also share relevant information with:

Study sponsors (in de-identified or limited form unless otherwise consented)
Healthcare professionals to administer care for you in case of an emergency or Adverse Event
Regulatory authorities, when required by law

Any other use or disclosure will require your written authorization unless requested or permitted by law.

Your Rights

The following is a statement of your rights with respect to your PHI and a brief description of how you may exercise these rights.

Access and obtain a copy of your PHI. This means you may inspect and obtain a copy of PHI about you that is contained in your profile, including medical and billing records and any other records that VCS may use for making decisions about you. Under federal law, however, you may not inspect or copy the following records: compiled information in reasonable anticipation of, or use in, a criminal, civil, or administrative proceeding or action; and PHI that’s subject to law that forbids access to PHI. Depending on the circumstances, a decision to reject access might be reviewable. In certain cases, you may have a right to review this decision.
Request corrections to your information.
Request limits on how your information is used or disclosed. For example, you could ask us to not disclose or use any part of your PHI for the purposes of healthcare operations, payment, or treatment. Also, you may request that any part of your PHI be undisclosed to friends or family members who might be involved for purposes of notification as described in this Notice or in your care. Your request should have the statement of the particular restriction requested and to who you want the restriction to apply.
Request to get confidential communications from us by alternative means or at an alternative location. Reasonable requests will be accommodated. Also, we might condition this accommodation by inquiring you for information as to how payment will be taken care of or specification of an alternative address or other contact methods. We will not request an explanation from you as to the basis for the request.
Get your provider to alter your PHI. This means you may request an amendment of PHI about you in a designated record set for as long as we maintain this information. In some cases, we might reject your amendment request. If we reject your request for amendment, you have the right to file a statement of disagreement with us, and we may prepare a rebuttal to your statement and will give you a copy of any type of rebuttal.
Get a list of specific disclosures we have made, if any, of your PHI. This right applies specifically to disclosures for purposes other than healthcare operations, payment, or treatment as described in this Notice. It excludes disclosures we may have made to you, for a facility directory, to friends or family members involved in your care, or for disclosures, or notification purposes for which you have signed an authorization. You have the right to gain specific information about these disclosures that happened after August 1, 2019. You may request a timeframe that’s shorter. The right to get this information is subject to specific limitations, restrictions, and exceptions.
Obtain a paper copy of this Notice from us, upon request, even if you are in agreement to accepting this Notice electronically.

Please email Privacy@validatedcs.com for any request. VCS is not required to agree to a restriction that you may request. If VCS believes it is in your best interest to permit the use and disclosure of your PHI, your PHI will not be restricted. If VCS is in agreement with the requested restriction, we may not disclose or use your PHI in violation of that restriction unless it’s required to give emergency treatment.

You can also file a complaint with the Secretary of Health & Human Services or directly with VCS if you believe your privacy rights have been violated

Term and Data Retention

As per FDA and Regulatory guidelines, there is no maximum retention policy on PHI in the US. VCS does not follow General Data Protection Regulation (GDPR) standards for participant data deletion – information collected during a clinical study may be retained and used as described in the applicable informed consent document and as required by regulatory authorities. Accordingly, VCS does not delete PHI on any set schedule – requesting deletion from our database will exclude you from further contact, however any images, photos, likenesses or secondary answers/commentary provided during studies cannot be revoked once it has been given and VCS has no control over third party usage once data has been released.

Participants are compensated with this notion in mind – they are “releasing” the rights to their likenesses and/or their statements to VCS and to Sponsors indefinitely, without the ability to retract at a later date.

Study Participant Frequently Asked Questions:

What is a clinical research study?

Many companies run studies to determine how well a product works before it enters the marketplace. They may use this information for advertising purposes or regulatory support.
Clinical studies are voluntary, and you may withdraw at any time without obligation or prejudice.
All Clinical Research Studies have a standard Informed Consent which you will review and sign prior to participation. This Privacy Notice is not an Informed Consent and is only intended to register you into our Database for potential participation in future studies.

What do I need to do to be considered for a clinical research study at VCS?

Schedule an appointment to complete your onboarding.
Complete the Datacapt Registration Questionnaire.
Provide contact information so that we can add you to our secure database and contact you for studies. We may contact you by calling, texting and/or emailing. We will never share your contact details with any unauthorized third parties, under any circumstances, without your explicit permission.
Provide Social Security Number (SSN) or Individual Taxpayer Identification Number (ITIN) for compensation purposes.
Provide some personal details that will help us determine which studies are a good fit for you, such as:
• Basic demographic information (age/sex/race).
• Skin and hair condition information.
• Medical and lifestyle history information.
Agree to have photographs taken that we can add to our database. This will allow us to determine if you are a candidate for a particular study.

If you have any questions, a VCS staff member will be happy to answer them. This document will be available upon request at any time. Completing the onboarding process and the Datacapt Registration Questionnaire does not guarantee future participation in clinical studies; each study has its own unique sets of criteria and requirements.

What will I need to do if I choose to be on a study?

You will be required to read and sign an Informed Consent Document that will explain study procedures and requirements in detail.Use the test product as instructed for the duration of the study; this may be a one-time application onsite or multiple uses over a course of days or weeks at homArrive for study visits on-time as scheduled and follow study specific instructions.

What types of products will I be testing?

You may be contacted to test a variety of topical products, such as moisturizers, lotions creams, serums, masks, hair removal, hygiene, etc.

Can I tell my friends and family about the products I’m testing?

No. The products in testing may not be on the market yet, and there is strict confidentiality between VCS, our sponsors, and our participants. It is important to keep any information that you may have discerned during your studies completely confidential. You agree not to disclose any information about your feelings or opinions about any products tested, as well as any reactions to the performance of individual products or study findings you may become aware of, privately or publicly, with anyone outside of VCS staff.

What are the benefits of participating on a study?

Your participation may contribute to valuable scientific knowledge for products that will be available on the market.
You will have an opportunity to try new products and may see an improvement in the appearance and condition of your skin.

What are the risks of participating on a study?

It is possible to develop mild to moderate skin irritation (redness, dryness, itching, mild rash) in the area where you are using the product(s). However, if you do not have a sensitivity to personal care products, the likelihood of experiencing a reaction is low. If you experience irritation from a study product, the product treatment may be discontinued.
If a product enters the eye area, it may sting or burn. Always use caution when applying product to your face.

Will I be compensated for participating on a study?

If you agree to participate in clinical research studies, you will be paid via a reusable debit card (funds will be available on the card approximately 2 business days after the study completion date). If you are discontinued from the study, you may be paid based on the visits you have completed. By agreeing to participate in clinical research studies, you will be receiving financial compensation in the same manner as an “Independent Contractor” for tax purposes. If you make over $2000 per year, VCS has a mandatory obligation to submit a 1099 to you at the end of each fiscal year, and any additional compensation is eligible to be taxed. You are required to provide your SSN and ITIN to VCS for payments made to you for participation in a study that will be reported to the IRS as an income, as required by law. Any compensation over $2000 is eligible for automated state and federal withholdings, but in all instances the total earnings will be reported to the IRS by VCS. This agreement does not represent an employment contract between you and VCS.

How do I opt out from text/email communication?

You can unsubscribe from all VCS communication by emailing panelists@validatedcs.com or contacting +1 201-331-9300 ext. 0.

Limited Model Release

For the purpose of documenting specific skin types and conditions and enrolling potential test subjects into appropriate clinical studies, VCS will require full face photos taken during your onboarding visit in order to complete your registration into our database. These photos will remain completely confidential in all instances, except in the event a sponsor requests to review “potential study volunteers” before deciding to conduct a study. VCS may share photos along with some demographic details including age, sex, gender, ethnicity etc., completely exclusive of any other medical or personally identifying data, with the sponsor in these situations. VCS will not use your photographs publicly, for advertising purposes, or share them with sponsors outside of the reasons noted above under any circumstances without your explicit written consent (study specific). VCS also conducts before and after photography for marketing purposes, and you may sign a Photo Model Release to be a part of these studies as well, however participation is not mandatory.

Any personal and medical information that is obtained in relation to your registration as a panelist, or any future studies you may participate in will be kept confidential by VCS. The records will be uniquely coded to protect your identity. Full HIPAA (Health Insurance Portability and Accountability Act) and FDA (Food and Drug Administration) privacy measures will be in effect.

In some instances, VCS may also request to take specific condition photos (eczema, psoriasis, stretch marks, crepey skin, etc.). You can opt in or out, and that decision can impact your participation in individual future studies, but opting out of one study doesn’t exclude you from participating in subsequent studies.

Health Insurance Portability and Accountability Act (HIPAA) Information

Any personal and/or medical information that is obtained in relation to your participation in a study will be kept confidential by VCS. Our records are uniquely coded to protect your identity. Apart from medical emergencies and adverse events, full HIPAA and FDA privacy measures will be in effect. Your information will only be shared internally on a secure Cloud System or with an IRB (Institutional Review Board), and consulting physician as necessary on a given study. Sponsors will not have access to personal information such as your name, address, medical history, etc.

VCS has your consent to share your information internally and as needed with potential clients and relevant agencies as defined in paragraph above.

Additionally, VCS will use the medical information in its database so that VCS may be able to contact you to participate in future studies. Your authorization to VCS to use the medical information and data you provide has no end date. You have the right to revoke this authorization anytime, so long as VCS has not already relied on or used the information you provided for a study. Any photography or data that has already been collected must be maintained as per FDA, HIPAA, and GDPR standards – it will not be deleted upon request until all regulatory requirements for data retention have been met.

Only employees and applicable contractors who have signed a confidentiality agreement are permitted to access the database. VCS does not sell the identifying information in the database. Even if you take back your consent to participate in a study, the Use of Personal Information authorization will remain in effect. VCS will maintain your information on a secure server and will not disclose it outside of the conditions noted above. If a regulatory agency requests further information regarding your study or health data, VCS cannot take responsibility for security breaches which occur after the fact.

Confidentiality

As a product tester, you may become privy to extremely sensitive information about product specifics and company trade secrets. You agree not to disclose any information about the products, potential studies, or actual studies which you may become a part of unless required by law. You may not share your feelings or opinions about any products tested, as well as any reactions to the performance of individual products or study findings you may become aware of, privately or publicly, with anyone outside of VCS staff.

Electronic Signatures

Documents to be delivered in connection herewith and therewith may be electronically signed, and any digital or electronic signatures (including PDF or electronic signatures provided by Datacapt or any other digital signature provider) appearing on such documents are the same as handwritten signatures for the purposes of validity, enforceability and admissibility. Each Electronic Signature will have the same legal effect, validity, and enforceability as a manually executed signature or the use of a paper-based record keeping system, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act and any other applicable law, including, without limitation, any state law based on the Uniform Electronic Transactions Act or the Uniform Commercial Code.

Agreement to Participate

I agree that my participation in the registration process is entirely voluntary, and I understand I have the right to refuse to participate or withdraw my participation at any time. I have read all the pages of this document and have been given an opportunity to ask questions about this process. I am satisfied with all the answers that have been given.

This is not an Informed Consent Document, nor am I enrolling in any clinical study at this time. All Clinical Studies at VCS have a study specific ICH-GCP compliant Informed Consent Document, and should I consider participating in a future clinical study I will have the opportunity to review the consent and ask any questions that may arise.

I am at least 18 years old and without reservation give my consent to provide the required information to VCS and complete the registration process. I understand that I will not give up any of my legal rights as a paid volunteer, however, I will abide by the non-disclosure clause, and I have hereby authorized VCS to utilize my medical and personal information in the manner described herein for regulatory compliance and scientific research. I acknowledge that VCS will maintain copies of all information submitted for compliance purposes.

Complaints

You may file a complaint with the Secretary of Health & Human Services or directly with VCS if you believe your privacy rights have been violated. You may file a complaint with us by emailing our Privacy Security Officers at privacy@validatedcs.com.