Most people who are interested in volunteering for a clinical trial have many questions. This page is designed to answer the most common questions our recruitment team receives from volunteers. Please do not hesitate to contact a recruiter by phone or email if you would like additional information or have a question that is not addressed on this page. We want to ensure that you are well informed before you agree to volunteer for a trial and we are happy to answer any questions you might have.
What is a clinical Trial?
What are the benefits of being a volunteer?
Are clinical trials safe?
How do I enroll in a study?
What should I bring when I stay overnight?
What am I NOT allowed to bring?
Can I have visitors?
Can I participate in more than one study? Can I be enrolled in more than one study at a time?
Do I have to do a physical screen for each study?
When will I know if I am in the study?
Is food provided? What will I eat?
Do I have to fast during studies?
When will I receive my compensation?
Is my compensation taxed?
The compensation says "Up to." What does this mean?
Is there a workout room? Can I exercise during my inpatient stays?
Is there a laundry room?
Where do we sleep? Do we share rooms?
Glossary of Terms
What is a clinical Trial? {Back to top}
A clinical trial or research study is a study in human volunteers to evaluate medications or devices to answer specific health questions. Clinical trials that are performed under international and federal regulatory standards are the fastest and safest way to find treatments that work in people and ways to improve health.
What are the benefits of being a volunteer? {Back to top}
Volunteers can take pride in knowing that they are helping others and in some cases gain access to treatments before they are available to others. In most trials volunteers also benefit by receiving free medical tests, exams and medications while receiving financial compensation for study participation time.
Are clinical trials safe? {Back to top}
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect participants. There are risks to clinical trials so it is very important for volunteers to learn as much as possible about a trial before their participation begins.
How do I enroll in a study? {Back to top}
The Enrollment Process
To begin the enrollment process you must first contact one of Prism’s three recruiters: Kevin Fitzgerald, Bill Haessly or Molly Hair. They can be reached by phone or email.
Kevin Fitzgerald: 651-641-2911, kfitzgerald@prismresearchinc.com
William Haessly: 651-641-2908, whaessly@prismresearchinc.com
Molly Hair: 651-641-2907, mhair@prismresearchinc.com
Your recruiter will guide you through the enrollment process. You are encouraged to ask your recruiter any questions you might have. A list of frequently asked questions and answers is found on this website.
Step One: The Phone Screen
The Phone Screen is a conversation between potential volunteers and a recruiter. It is the first required step in participating in a clinical trial. At the time of the phone screen your recruiter will ask you a series of inclusion criteria questions. These are general questions concerning your contact information, height and weight, age, race and personal health history. By collecting this information, your recruiter will determine if you might fit the criteria for any up coming studies.
Many of the phone screen questions can be answered over email if you download your information into our database. Doing so will notify our recruitment team that you are interested in studies, will register you for study updates and will also speed up the phone screen process.
Once your information has been added into the database (by download or by speaking with a recruiter) your recruiter will then discuss the details of any studies you might qualify for. He will explain the time commitment, specific dates, research purpose and compensation of the trials.
If you are interested in participating in a suggested trial, your recruiter must then make certain that you are not disqualified from that trial due to any exclusion criteria. You will be asked another series of questions that specifically relate to the study you are volunteering for. The exclusion criteria are established by the study sponsor in order to ensure the safety of volunteers and the accuracy of data collected.
If your recruiter determines that you qualify to proceed with the enrollment process and you wish to continue, he will than arrange for a Physical Screening appointment.
Step Two: Informed Consent and the Physical Screen
Volunteers are required to provide a photo ID at the time of the Physical Screen. If their photo ID does not list a current address, volunteers must provide additional documentation of their address such as a utility or cable bill.
It is mandatory that all potential volunteers review the informed consent. This is regarded as the most important process in clinical trials. The Informed Consent is a document that details all aspects of the research study, the potential risks involved and what happens during the entire study. It is approved by an ethics and safety committee called the Institutional Review Board (IRB). No study related procedures or requirements can be started on volunteers until they understand and sign the study related informed consent form. Volunteers receive a copy of the Informed Consent Form.
You will be required to sign the Informed Consent if you are interested in continuing the enrollment process. The Informed Consent does not legally obligate you to participate in the trial. It also does not guarantee you a position in the trial. It is a document designed to protect your rights as a volunteer; it confirms you have been given information concerning all aspects of the trial and that you understand what will take place during the trial.
Once you have signed the Informed Consent, the Physical Screen can begin. Each trial requires a different series of procedures as part of the Physical Screen. Common procedures include: blood draws, heart monitoring, vital signs, body measurements, urine samples, and drug tests.
You will also meet with a doctor or nurse practitioner at the time of your Physical Screen. He or she will perform a brief physical and discuss your personal health history. Volunteers are strongly encouraged to ask him/her any questions you might have concerning the study.
All trials require a minimum of one Physical Screen, however; some studies require multiple screening appointments. Some studies also require hearing or eye exams which take place at clinics working in conjunction with Prism. Your recruiter will outline the screening schedule at the time of your Phone Screen.
Once all of your lab work has been completed and reviewed, a Prism staff member will call to notify you of your enrollment status. If your lab results meet the requirements for the study, the staff member will confirm your enrollment and give you admit instructions.
What should I bring when I stay overnight? {Back to top}
Bedding: It is a good idea to bring a comforter/blanket/sleeping bag. The blankets provided by Prism are great for use in the dosing room, but most volunteers prefer to bring their own blankets for sleeping.
Clothing: Volunteers should bring comfortable clothing like loose fitting shirts, jeans, sweatpants. Our building is air conditioned, so packing a sweater or sweatshirt is a good idea.
Women should bring a bra that does not have any under-wire because the metal in under-wire bras can disrupt the heart monitoring machines.
Personal toiletry items: Soap, toothpaste, deodorant, shampoo/conditioner, etc.
Personal items: Volunteers can feel free to bring DVDs, CDs, music listening devices, laptop computers, cell phones, books, schoolwork or work from the office, sketchbooks, knitting and games. In general, any personal hobbies that are not distracting or offensive to other volunteers/staff members will be allowed. If you are wondering if you can bring a particular item, please ask your recruiter.
Prism provides: clean sheets, thin blankets, towels, washcloths, and one pillow per bed.
What am I NOT allowed to bring? {Back to top}
The following list of items is not allowed unless approved by Prism staff prior to the first day of the study:
- Prescription or over the counter medications (with the exception of birth control pills)
- Vitamins, herbal supplements, or dietary supplements
- Cigarettes, chewing tobacco, cigars and any other tobacco or nicotine containing products
- Food of any kind. This includes chocolate, candy, gum, and other snacks.
- Illicit drugs
Can I have visitors? {Back to top}
Volunteers in studies that last more than 3 days are allowed visitors. Visitors are allowed until 3:00 in the afternoon, Monday through Friday. Weekend visitors are not allowed. Visitors will undergo a bag check and may be asked to empty their pockets before entering the building. Visitors can not enter sleeping rooms and must remain in the common area. The arrival time and length of all visits must be approved by the Prism staff before visitors arrive. The staff of Prism reserves the right to decline visitation requests for any reason.
Can I participate in more than one study? Can I be enrolled in more than one study at a time? {Back to top}
Volunteers can do as many studies as they qualify for, but they can not be enrolled in more than one study at a time. Every trial requires a “wash out period” that is usually 30 days) between any two studies. Some studies require a longer wash out period. Every study is different; your recruiter will help you schedule studies based on the wash out criteria.
Do I have to do a physical screen for each study? {Back to top}
Yes. Each study has different requirements, so a new physical screen must take place before you may participate in a trial.
When will I know if I am in the study? {Back to top}
Before Prism can confirm your enrollment we must receive and review your lab results. Sometimes this process can take several days.
Is food provided? What will I eat? {Back to top}
All meals are provided by Prism at no cost to the volunteers. All menus are created based on the requirements of each particular study, so the food items served will vary from study to study. Some studies have very specific menus and may require that volunteers consume the entire portion of food items served. Please discuss any personal dietary concerns with your recruiter; he will let you know if any upcoming studies can accommodate your special dietary needs.
Do I have to fast during studies? {Back to top}
Most studies do require periods of fasting before and after a dose of medication is administered. Your recruiter can discuss these fasting periods with you. You will also be notified of the length of each fast in the study specific Informed Consent document.
When will I receive my compensation? {Back to top}
All compensation checks are issued within 7 to 10 business days after the final study procedures have been reviewed. All compensation checks are mailed to the volunteers.
Is my compensation taxed? {Back to top}
Compensation amounts are not taxed; however, volunteers must claim the earnings from study participation as income on their annual taxes. Every January a W-2 form will be mailed to all volunteers who participated in a trial during the previous calendar year.
W-2s are mailed no later than January 31 of each year. To insure timely and accurate delivery of your W-2 from, please notify Prism if you have changed your address after participating in a trial.
The compensation says "Up to." What does this mean? {Back to top}
All volunteers who complete the entire study will receive the entire compensation amount. Volunteers who do not complete the entire study will receive a prorated amount based on the number of days completed. The dollar value associated with each day is clearly outlined in the Informed Consent.
Volunteers who test positive for illicit drugs will be compensated no more than $10.
Is there a workout room? Can I exercise during my inpatient stays? {Back to top}
Prism does not have a workout room. The natural effects of exercise in the human body (such as elevated heart rate and liver enzymes, sweating, and flushing of skin) can invalidate the data collected during the study. For this reason, exercise is not allowed during inpatient stays.
Is there a laundry room? {Back to top}
There is no laundry facility at Prism. Volunteers are encouraged to bring enough clean clothing to last throughout their stay.
Where do we sleep? Do we share rooms? {Back to top}
Volunteers are assigned a semi-private sleeping room. It is likely that volunteers will share rooms with at least one other person. All rooms have drawers for clothing, night stands and satellite TV and DVD players.
Glossary of Terms {Back to top}
Adverse Event (AE): An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical or device product that does not necessarily have a causal relationship with this treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational) product.
Clinical Trail/Study: Any investigation in human subjects intended to discover or verify the clinical, pharmacological, and or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s) and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trail-related duties and functions.
Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
HIPAA: HIPAA is the acronym for the Health Insurance Portability and Accountability Act of 1996. The Centers for Medicare & Medicaid Services (CMS) is responsible for implementing various unrelated provisions of HIPAA. They are required to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data.
Informed Consent Form (ICF): A document approved by an authorized Independent Ethics Committee by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trail that are relevant to subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
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 for the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied the o the subject.
Independent Ethics Committee (IEC): An independent body (a review board or a committee, institutional, regional, national or super national) constituted of medical/scientific professionals and nonmedical/nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved n a trail and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigators(s), facilities, and the methods and material to be used in obtaining and documenting informed consent for the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to IEC may differ among countries, but should allow the IEC to act in agreement with Good Clinical Practice.
Institutional Review Board (IRB): And independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols, amendments, and methods and materials to be used in obtaining and documenting informed consent of the trial subjects.
Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference n a clinical trial including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication or when used to gain further information about an approved use.
Investigator: A person responsible for the conduct of the clinical trail at the trail site. If a team of individuals at a trial site conducts a trial, the investigator is the responsible leader of the team and may be called the Principal Investigator.
Legally Acceptable Representative: An individual or juridical or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the clinical trail.
Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial.
Randomization: The process of assigning trial subjects to treatment or control groups using and element of chance to determine the assignments in order to reduce bias.
Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
Subject/Trial, Subject/Volunteer: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated worth participation, or of a retaliatory response from senior members of a hierarch in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, member of the armed forces and persons kept in detention. Other vulnerable subjects include patients with incurable disease, persons in nursing homes, unemployed or impoverished persons and patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors and those incapable of giving consent.
Well-being (of trial volunteers): The physical and mental integrity of the subjects participating in clinical trial. {Back to top}