Institutional Review Board/Human Subjects Protection Office (IRB/HSPO)

The Human Subjects Protection Office (HSPO) is the Institutional Review Board (IRB) program office at Penn State College of Medicine and Penn State Health.

An Institutional Review Board is a federally mandated entity that oversees the protection of human subjects in research. IRBs help mitigate potential risks to participants, including their physical and psychological well-being, confidentiality and privacy and autonomy, among others. At Penn State, an IRB must review all research involving human subjects, and the research cannot begin until the IRB has reached a determination. This is true even if a researcher perceives there are no risks for people who participate in their research.

A round logo shows the words Association for the Accreditation of Human Research Protection Programs, Inc. around the outside and the words Full Accreditation in larger text inside the circle.Penn State has one IRB at University Park and five IRBs at the College of Medicine. The HSPO provides administrative support for the IRBs at Penn State College of Medicine and Penn State Health and assists faculty and staff with the requirements to meet ethical and regulatory standards for human research.

In addition, HSPO program staff, who are IRB analysts and IRB coordinators, review certain categories of research on behalf of the IRB. The HSPO reports to the Director of the Office of Research Protections at University Park. The IRB program within the Office for Research Protections provides administrative support for the University Park IRB that oversees human subjects research at all University colleges and campus locations except the College of Medicine and Pennsylvania College of Technology.

In addition, the institution has successfully met the criteria for full accreditation of its human subjects protection program by the Association for the Accreditation of Human Research Protection Programs. This accreditation is valid from March 2015 to March 2020. See details here.

All submissions to the IRB are handled through the Centralized Application Tracking System (CATS).

Access CATS IRB here

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IRB/HSPO News, Notices and Updates Expand answer

IRB/HSPO news, notices, updates and announcements are sent by email to keep faculty and research staff informed of new information and changes, and are also linked to here.

See previous IRB/HSPO news, notices, updates and announcements

IRB Trainings and Workshops Expand answer

Workshops and seminars

Workshops and seminars are repeated periodically based on interest. Recurring topics include CATS IRB Training, IRB Process Overview for Researchers, Informed Consent Process for Research, Reportable New Information for Research, Research Document Management and IRB Policy for Security and Integrity of Human Research Data.

Call the HSPO at 717-531-5687 or email hspo@pennstatehealth.psu.edu to register, or to be placed on a waitlist if a topic you are interested in is not available.

IRB Human Research Training

Penn State requires completion of the following two courses:

  • Protection of Human Research Subjects course – Required for initial and continuing education (every three years) for investigators and study staff of human research studies.
  • Good Clinical Practice (GCP) course – Additional requirement for investigators and staff of Non-Exempt human research studies, along with the above course.

The training is offered through the Collaborative Institutional Training Initiative at the University of Miami (CITI), which may be accessed at citi.psu.edu.

The CITI course instructions provide the steps to enroll or to affiliate from another institution.

For details on training requirements, access the Investigator Manual in CATS IRB and refer to the section “What training is required to conduct Human Research?”

Research consultations

Contact the HSPO to schedule a meeting to discuss a research submission and IRB requirements.

Educational presentations

Speakers are available to provide presentations on human subjects protection topics to departments, groups and community organizations, and may be requested by contacting the HSPO.

IRB Review Process and Schedule Expand answer

Incoming submissions to the IRB are addressed in the order received. New submissions for committee review undergo a pre-review process, after which researchers may be required to make changes for completeness. Once a submission is complete it is placed on the next available agenda. Exemptions and expedited submissions are reviewed in the order received.

Submissions for continuing review of ongoing research are due by the date listed on the reminder notice, and are assigned to the next available agenda (or expedited reviewer) to ensure there is no lapse in IRB approval. Other submissions are reviewed in the order received, unless the submission involves an urgent issue that may affect participant safety.

A number of factors affect the timing of communicating review results to investigators, including the type of submission, quality of the submission, and available IRB member expertise and staff, but typically a researcher can expect to receive the results of a submission review within the following timeframes:

  • Committee review (full board): Four to six weeks
  • Expedited review: two to four weeks
  • Exemption review: one to two weeks

Upcoming board review meetings are listed here.

Applying to be a Member of the Institutional Review Board Expand answer

Institutional Review Boards (IRB) are specifically designated boards that conduct ethical and safety review of research involving the participation of human subjects. Four IRBs (Boards A, B, C and D) review proposed and ongoing research at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.

In order to conduct thorough reviews of research, IRBs include members with varied experience and expertise, including medical, science and non-scientist perspectives and community representatives serving as non-affiliated members. Each IRB member reviews materials and attends board meetings prepared to discuss proposed research within their realm of expertise or experience. Individuals interested in serving on the IRB need only an appreciation for the importance of clinical research and an interest in protecting research participants. Educational resources are provided to help all members gain the necessary information base regarding research protection.

IRB membership involves attending one regular monthly meeting, generally 1 to 5 p.m. on a Monday afternoon, and also spending time reading materials in advance to prepare for the IRB discussions. A typical IRB member’s overall time commitment is six to eight hours per month. The IRB materials are reviewed electronically and are accessible about 10 days before a meeting. Board members bring a laptop or other device to access and view these materials during the IRB meetings.

Members of the IRB are covered under the institution’s liability insurance for their service on the board. Penn State Health and Penn State College of Medicine employees and students are automatically covered. Community IRB members are required to register with the institutional Volunteer Services office in order to be included in this insurance coverage before beginning IRB service, and instructions will be provided for this process.

For details, contact the Human Subjects Protection Office at 717-531-5687 or hspo@pennstatehealth.psu.edu.

Complete an IRB membership application

IRB Assurance and Compliance Statement Expand answer

Penn State College of Medicine holds Federalwide Assurances (FWA) from the Office of Human Research Protection (OHRP), under the U.S. Department of Health and Human Services (DHHS), as follows:

  • Penn State College of Medicine (IORG#0000031), Federalwide Assurance (FWA) #4251 (Expires: 05/16/2024); includes Penn State College of Medicine IRB 1 (IRB00000046); IRB 2 (IRB00000047); IRB 3 (IRB00000048); IRB 4 (IRB00002337); and IRB 5 (IRB00011842)

Information on the IRB registrations is available by searching here for Penn State College of Medicine.

The Penn State College of Medicine FWA lists Penn State Health as a component. Penn State Health includes the following:

  • Penn State Health Milton S. Hershey Medical Center
  • Penn State Health Community Medical Group
  • Penn State Health St. Joseph Regional Health Network
  • Penn State Health St. Joseph Medical Group

The Institutional Review Boards operate in compliance with DHHS and Food & Drug Administration regulations (45CFR46, 21CFR50, 21CFR56) for protection of human subjects, Commonwealth of Pennsylvania law and Pennsylvania State University policies for human subjects research. For clinical trials, the organizations commit to apply the Harmonised Tripartite Guideline for Good Clinical Practice E6 (ICH-GCP).

The IRBs follow institutional written policies and procedures for operation, and maintain IRB review documentation in a closed electronic system (CATS IRB) that conforms to 21 CFR Part 11 (Electronic Records: Electronic Signatures) for research subject to FDA regulation, as outlined in the IRB Statement of 21 CFR Part 11 Compliance document.

The IRBs comply with regulatory membership requirements (45CFR46 and 21CF56), register membership rosters with the Department of Health and Human Services, and provide membership rosters to regulatory authorities as required.

Patricia Gordon, MD, Associate Professor of Pediatrics/Human Genetics, serves as the IRB executive chair. Penn State College of Medicine maintains four boards with a chair, vice chair and 14 to more than 20 members each, and a fifth board that reviews urgent issues. The IRB Roster Representation provides information about the IRB membership categories and expertise represented.

See a printable version of the Assurance and Compliance Statement here.

Current IRB Roster Representation Expand answer

The current composition of the Institutional Review Boards is listed here. See a printable version of the IRB Roster Representation here.

IRB/HSPO Staff Expand answer
Review Board Chairs Expand answer
Contact the IRB/HSPO Expand answer

Phone: 717-531-5687

Email: hspo@pennstatehealth.psu.edu

Mailing address: Penn State Health Milton S. Hershey Medical Center
Penn State College of Medicine
Human Subjects Protection Office
Institutional Review Board
Mail Code A115, Academic Support Building, Room 1140
90 Hope Dr., P.O. Box 855
Hershey, PA 17033-0855

Questions, complaints or concerns: Any questions, complaints or concerns related to research involving human participants conducted at or under the auspices of Penn State College of Medicine or Penn State Health Milton S. Hershey Medical Center can be directed to the Director of the Human Subjects Protection Office, Dr. Kathleen Hay, at 717-531-1646 or khay@pennstatehealth.psu.edu. You may also submit the comment/suggestion form, through which you can choose to receive a response or remain anonymous.

For after-hours urgent concerns regarding human subjects protection, the IRB Executive Chair, Dr. Patricia Gordon, or another IRB Chair may be contacted through the hospital operator at 717-531-8521.

IRB/HSPO Tools and Resources

Emergency Use Submission Instructions Expand answer

Use the following format for a proposed emergency use submission and email it as instructed below. Resources for Emergency Use of Investigational Test Articles are available in CATS IRB, including:

  • HRP-582 – HSPO Consent Form for Emergency Use
  • HRP-023 – SOP Emergency Use
  • Post Emergency Use Report template
  • HRP-322 Worksheet – Emergency Use
  1. Confirm in the email that the circumstances meet the following criteria for emergency use:
    • The patient is confronted by a disease or condition that is life-threatening or severely debilitating, or the patient is confronted by a life-threatening disease or a serious condition requiring immediate use of an unapproved device.
    • The situation necessitates the use of the test article (drug, biologic, device).
    • No generally acceptable alternative for treating the patient is available.
    • There is insufficient time to obtain IRB approval. (Or if there is time for review at the next IRB meeting, indicate this and the information will be added to the agenda.)
    • Note: The above findings for emergency use must also be noted in the medical record.
  2. Attach the following materials to the email as supporting documentation:
    • Document or email that describes the patient’s medical condition and the reason for the use of the test article. (Do not include any identifiers in documents.)
    • Correspondence to and from the FDA with the investigational new drug (IND) number or investigational device exemption (IDE) number, if available. (For a single-patient IND or compassionate IDE, submit the number when it is available).
    • Correspondence to and from the sponsor regarding use of the test article.
    • Protocol or detailed treatment plan for this patient.
    • Investigator’s brochure or drug package insert, or device information.
    • Emergency use consent form to be used. (Use “HRP-582 – HSPO Consent Form” in CATS IRB.)
  3. Send the email and all subsequent communications about the emergency use to IRB Executive Chair Dr. Patricia Gordon (pgordon@pennstatehealth.psu.edu) or to chair contacted; and to HSPO Director Kathleen Hay (khay@pennstatehealth.psu.edu) or to staff member contacted; also copy other persons involved in coordinating the use.
  4. Keep the Human Subjects Protection Office informed about the status of a proposed use to proceed or if circumstances change.
  5. By close of business within five days after the use of the device or first administration of the drug/biologic, submit to the IRB written notification of the emergency use of a test article in a life-threatening situation, and include a copy of the signed consent document used (or provide certification by the treating physician and an uninvolved physician that the criteria for the exception from informed consent were met). For this report, use the “Post-Emergency Use Report Template” elsewhere on this page.
Informed Consent Language Required for Genomic Studies Expand answer

As part of the NIH Genomic Data Sharing Policy Requirements for Informed Consent, for studies started after Jan. 25, 2015, investigators must obtain subjects’ consent for:

  • Their genomic and phenotypic data to be use for future research
  • Their genomic and phenotypic data to be shared broadly

The consent form should include an explanation about whether subjects’ individual-level data will be shared through unrestricted- or controlled-access repositories.

Consent must be obtained even if the genomic data are from de-identified cell lines or clinical specimens. See the NIH policy and supplemental information here.

Section 2: What will happen in this research study?

For research that has the potential to generate large-scale genomic data, include the following information about using research data for future research studies and sharing the research data broadly.

Storage and sharing of research data for future research: Researchers can do studies that are more powerful when they share with each other the data or information they get from studying human samples. They share this information with each other by putting it into scientific databases. There are different kinds of databases. Some are unrestricted-access databases (publicly accessible) that anyone on the internet can obtain information. Others are controlled-access databases that are available only to researchers who have received approval from data access committees. Some of these databases are maintained by Penn State College of Medicine (COM) and Penn State Health Milton S. Hershey Medical Center (HMC), some are maintained by the federal government, and some are maintained by private companies and other institutions.

(If the research data will be shared with unrestricted-access databases, add the following statement.) Anonymous genetic and health information from the analyses of your samples may be put in one or more of the unrestricted-access databases. This information will be used for future research. Your name and other information that could identify you will not be included in the database. Therefore, no one would know just from looking at the data that the information came from you.

(If the research data will be shared with controlled-access databases, add the following statement.) Your coded genetic and health information may be put in one or more of the controlled-access databases and used for future research. Your information stored in these databases will not include any identifying information such as your name, address, telephone number, or social security number. We will replace this identifying information with a code number. We will keep a master list that links your code number to your identifying information here at Penn State College of Medicine (COM) and Penn State Health Milton S. Hershey Medical Center (HMC). Only certain research staff members at COM/HMC will have access to this master list.

(Add the following statement about the return of results from future research.) You should not expect to get personal results from the future research done on your samples and information. Researchers will study samples and information from many people; it will take many years before they know if the results have any meaning. However, in the future it may be possible for researchers to give you your genetic research results. There is also a small chance that researchers could find something that might be important to your health. If this happens, we may contact you to find out if you would like to learn more. However, even if we find something important to your health, we cannot guarantee that you will be contacted.

Section 3: What are the risks and possible discomforts from being in this research study?

(Add the following risks for the storage and broad sharing of genomic and phenotypic data for future research.) There is a risk that someone in the future could link your genetic or medical information stored in the databases back to you. If your information suggested something serious about your health, it could be misused. For example, it could be used to make it harder for you to get or keep a job or insurance; however there are laws against this kind of misuse.

It also is possible that there could be violations to the security of the computer systems used to store the codes linking your genetic and medical information to you. There may be other unforeseen privacy risks.

We believe the chance these things will happen is very small, but we cannot guarantee that your identity will never become known. Your privacy and the confidentiality of your data are very important to us and we will make every effort to protect them.

Although we will not give researchers your name, we will give them basic information such as your race, ethnic group, and sex. This information helps researchers learn whether the factors that lead to health problems are the same in different groups of people. It is possible that such findings could one day help people of the same race, ethnic group, or sex as you. However, they could also be used to support harmful stereotypes.

There is a federal law called the Genetic Information Nondiscrimination Act (GINA). Generally, GINA makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, GINA does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. It also does not prohibit discrimination on the basis of already known genetic disease.

7a. What happens to the information collected for the research?

(Add the following text if a Certificate of Confidentiality is obtained from the federal government for this project.) To help protect your privacy, a Certificate of Confidentiality will be obtained from the National Institutes of Health. This Certificate means that the researchers cannot be forced (for example by court subpoena) to share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.

The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of Federally-funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.

(The researchers should include language such as the following if they intend to make voluntary disclosure about things such as child abuse, intent to hurt self or others, or other voluntary disclosures.) The Certificate of Confidentiality will not be used to prevent disclosure to state or local authorities of [list what will be reported, such as child abuse and neglect, or harm to self or others].

Instructions for Tracking of Disclosures Expand answer

Disclosure means the release, transfer, provision of access to, or divulging in any other manner of protected/personally identifiable health information (PHI) to any person who is not participating in carrying out the research protocol, whether or not employed by Penn State Health or Penn State.

Federal privacy regulations require that a record be made of a disclosure of any personally identifiable health information that is made without an authorization by the research participant. Therefore, tracking of disclosures will have to be undertaken for all disclosures when:

  • there is a waiver of authorization,
  • there is an approval for review preparatory to research,
  • there is an approval for the use of a decedent’s PHI obtained for purposes of research, and
  • for any disclosures not previously specified in a signed authorization document.

When the Review Involves the Disclosure of PHI From 50 or Fewer People

The following information about any disclosure must be recorded and made available to the IRB and the individual who is the subject of the PHI upon request:

  • Date of disclosure;
  • Name of person/entity that received the PHI;
  • Description of what PHI was disclosed; and
  • Brief statement regarding the purpose of the disclosure.

If a research protocol requires multiple disclosures to the same outside party over a period of time, the following information is adequate:

  • For the first disclosure, all of the above must be recorded.
  • For subsequent disclosures, tracking can refer to the initial record of disclosure and should include the frequency, periodicity or the number of disclosures that will be made; also, the date of the last disclosure must be documented.

When the Review Involves the Disclosure of PHI From More Than 50 People

Federal privacy regulations allow a modified tracking method. In this instance it is unnecessary to maintain a list of the specific persons about whom PHI has been disclosed. The following information about any disclosure must be recorded and made available upon request to the IRB and any individual who may have been included in the review:

  • The name and description of the protocol;
  • Brief descriptions of types of PHI disclosed;
  • Dates or time periods during which disclosures occurred; and
  • Contact information (name, address, telephone number) for sponsors and recipient researchers.

In addition, the Penn State Health/Penn State researcher must also assist in contacting the sponsor and recipient researcher if it is reasonably likely that an individual’s PHI was disclosed to them.

Tracking information as required by privacy regulations must be maintained by the principal investigator at least six years, and made available to the Privacy Officer.

Phone Screen Procedure Guidance Expand answer

For detailed instructions see the IRB policy “Recruitment of Research Participants” in the CATS IRB library.

IRB policy requires that the initial contact, regardless of method, must come from a person who can be expected to be reasonably familiar to the potential research participant, such as a physician or health care provider directly engaged in the patient’s clinical care or an acceptable representative or a physician or health care provider from the clinical unit in which the patient has been seen, or a referring physician.

Phone scripts should inform the potential participants of the following:

  • Name and address (department) of the investigator;
  • How their names were obtained, e.g., seen in a particular clinic or had a specific type of surgery in the past;
  • Why they are being contacted about participation in a research study, e.g., medical diagnosis or history, or age criteria; (Use the word “research”);
  • Summary of the purpose of the research with a brief listing of major eligibility criteria;
  • Factual description of the benefits to the participant from participation in the study, if applicable;
  • Compensation if provided (but do not state dollar amount);
  • Location of the research and contact information;
  • That participation will not affect current or future care;
  • Whether results of the research will be released to the participants;
  • Plans to recontact individuals again by phone or mail, and an outline of the conditions under which recontact will happen, if applicable.

Example: Phone screening script when no identifiable health information is recorded

  • A phone call will be placed by ____ (In this section, explain how the contact complies with IRB initial contact requirements above, or explain if subjects will call in response to an advertisement.)
  • We give a synopsis of the study:
    • Purpose of the study
    • Procedures
  • We answer any questions that the subject may have.
  • We then ask them, “Does this sound like something you would like to do?”
  • If they answer yes, we ask them some basic eligibility questions but no identifiable information is recorded at this time.
  • If they are eligible based on these screening questions, we schedule them for a visit.

Example: Phone screening script when identifiable information is recorded

  • A phone call will be placed by ____ (In this section, explain how the contact complies with IRB initial contact requirements above, or explain if subjects will call in response to an advertisement.)
  • We give a synopsis of the study:
    • Purpose of the study
    • Procedures
  • We answer any questions that the subject may have.
  • We then ask them, “Does this sound like something you would like to do?”
  • If they answer yes, we read the following statement: “I will be asking you some questions about your health information and medical history to determine if you are eligible for this research. By answering these questions, you are consenting to allow us to use this information to pre-screen you for the study. With your permission we will retain this information in the locked research office, and if you are interested in participating in additional studies in our department, we will contact you for future studies. This information will not be shared with anyone outside of the (department name) research team. If you do not want us to keep your information, we will destroy it following the study. Do you want me to go ahead with the questions?”
  • If yes, say, “Do you want us to keep your information at the end of this study so that we can contact you for future studies?”
  • We then go through our phone screen form that is based on the general inclusion/exclusion criteria for that study.
  • If at any point during the process the subject doesn’t meet the criteria, we tell them that and stop asking questions unless they are interested in being contacted for future research studies.
  • We keep a screen fail notebook (to show sponsors how many potential subjects we have talked to). We enter in the notebook: “male caller, saw ad in the Patriot News, using beta-blocker.”
  • If the subject meets the initial phone screen criteria, we schedule them for a visit.

Example: Phone screening script when screening for sensitive issues

  • Subjects will be called after we have received a referral from a physician.
  • We read the following statement: “I will be asking you some questions about your health information and medical history to determine if you are eligible for this research. But before I begin, I want to let you know that because of the nature of the research that is conducted we do not enroll people who are HIV-positive, people who have abused alcohol or drugs within the past two years, people who have pre-existing psychiatric disorder including moderate/severe depression, suicide ideation/attempts. If you have a history of any of the above simply say you are not interested in participating when asked.”
  • We give a synopsis of the study:
    • Type of drug to be used
    • Purpose of the study
    • Procedures
    • Study visits (how many, time of day, time commitment from subject)
  • We answer any questions that the subject may have.
  • We then ask them, “Does this sound like something you would like to do?”
  • If they answer yes, we read the following statement: “I will be asking you some questions about your health information and medical history to determine if you are eligible for this research. By answering these questions, you are consenting to allow us to use this information to pre-screen you for the study. With your permission we will retain this information in the locked research office until the completion of study; your information will then be destroyed. This information will not be shared with anyone outside this research team. Do you want me to go ahead with the questions?”
  • We then go through our phone screen form that is based on the general inclusion/exclusion criteria for that study.
  • If at any point during the process the subject doesn’t meet the criteria, we tell them that and stop asking questions.
  • We keep a screen fail notebook (to show sponsors how many potential subjects we have talked to). We enter in the notebook initials, age, reason for exclusion.
  • If the subject meets the initial phone screen criteria, we schedule them for a visit.
Post-Emergency Use Report Template Expand answer

This template may be used to prepare a letter to the IRB to report the emergency use of an investigational drug, biologic or device. Items to be filled in are enclosed in [brackets].

DATE: [date]

TO: Patricia L. Gordon, MD
Executive Chair, Institutional Review Board

FROM: [submitter name and title]

I would like to notify the Institutional Review Board of an emergency use of a test article, name of article, covered by [IND number, IDE number or HDE number; specify which type]. The sponsor/manufacturer is [sponsor/manufacturer name]. The IND or IDE holder is [name of IND or IDE holder].

The patient [patient initials] was determined be in a life-threatening situation because [description of symptoms and clinical care that indicates the patient’s condition was life-threatening; do not include identifiers].

[Description that indicates that all standard avenues of treatment had failed or that there were no standard avenues of treatment].

[Indicate why there was no time to obtain formal IRB approval].

I contacted IRB Chair [name of chair contacted and their credentials] on [date] and they concurred that the emergency use was appropriate.

or

I attempted to contact all four IRB Chairs on date and was unable to reach them; therefore I proceeded to use the drug/biologic/device because time was of the essence, as described above.

[Date and time of first administration].

[Any adverse events or unanticipated problems to the patient or others; note that any subsequent developments must be reported to the IRB in a timely fashion].

[Outcome of the emergency use to date, if known].

The informed consent of the [say either patient or patient’s legally authorized representative] was obtained using the attached consent form.

or

The [drug/biologic/device] was used without the informed consent of the patient or the patient’s legally authorized representative. The patient was unable to provide consent because [reason for inability to consent]. All attempts to contact a legally authorized representative were unsuccessful and time was not sufficient to continue the attempt. The patient was confronted by a life-threatening situation and there was no alternative method of approved or generally recognized therapy available that would provide an equal or greater likelihood of saving the patient’s life. Dr. [independent physician’s name], an independent physician who is not participating in the clinical investigation for the [drug/biologic/device], was consulted and together we confirmed the above four conditions.

Attached are the following documents: [Include and list documents which were not previously submitted to the IRB for this emergency use]

  • [List any manufacturer information available on the product (e.g., protocol, drug brochure or device information)]
  • [Copy of the signed informed consent form (if applicable)]
  • [Report of the independent physician (if applicable)]
  • [Communications with FDA (if applicable)]
  • [Communications with the sponsor (if applicable)]

If you have questions or concerns, I can be reached at [your email address and best phone number and/or page number].

Request for Research on Decedents' Information Expand answer

Complete this form if you would like to review decedents’ information for research purposes.

Decedent Information Request

Review Preparatory to Research Request Expand answer

This form is required if protected health information of individuals who are not under the care of the investigators is desired to be reviewed before participants authorize this access.

Review Preparatory to Research Request

Suggested Consent Wording Expand answer

This suggested wording for the different situations that may apply to your research may be cut and pasted into the appropriate sections of the consent document. The wording may be edited as needed to make it applicable to your research. Items in [brackets] should be adjusted as appropriate.

1. Purpose of the Study

For research involving drug or devices: This [drug, device] has not been approved by the Food and Drug Administration and is considered experimental. (or)

This [drug, device] is approved by the Food and Drug Administration for the treatment of [approved indication] but the use of [drug, device] in this study is experimental. (or)

This [drug, device] is approved by the Food and Drug Administration for the treatment of [indication] and is commercially available. (or)

This [drug, device] is approved for treatment of another condition but is not approved for the use proposed in this research.

For Phase 1 clinical studies: The purpose of this study is to find the highest dose of [drug name] that people can safely tolerate. (or)

The purpose of this study is to test the safety of [drug] and see what effects (good and bad) it has on your [disease].

For Phase II clinical studies: The purpose of this study is to find out what effects (good or bad) [drug/intervention] has on you and your [disease].

For Phase III clinical studies: The purpose of this study is to compare the effects (good and bad) of [new drug/intervention] with [commonly-used drug/intervention or placebo] on you and your [disease] to see which is better. Currently, there is no effective treatment for [disease]. (or) We do not know which of these two commonly-used treatments is better.

For studies with genetic testing: Genetic testing will be performed on these samples to identify, confirm and validate biomarkers. Biomarkers are biological or chemical “markers” that can be found in the blood and tumor tissue. Cells in your body contain a type of molecule called deoxyribonucleic acid, or DNA for short. DNA is genetic material that carries the instructions for your body’s development and function. Genes are made of DNA, and DNA varies widely from one person to another. Each person’s body has tens of thousands of genes. Together, these genes make up the blueprint that determines how a person’s body will develop, grow and function. The information stored in a gene’s DNA is transferred to a similar molecule called ribonucleic acid, or RNA for short. In short, DNA makes RNA, and RNA makes proteins. Proteins are the building blocks of your cells.

2. Procedures to be Followed

For research involving randomization: You will be randomly assigned to receive one of the [number] study treatments, either [list or name the study treatments]. This means that whichever study treatment you receive will be determined purely by chance, like flipping a coin. You will have a [give the odds of being in any study group, e.g., equal chance, 1 out of 3, etc.] chance of receiving any one of the study treatments.

For double-blind studies: Neither you nor the research team will know which study treatment you are receiving, but we will be able to get this information quickly if we need it to ensure your safety.

If the research involves a screening visit: Consent must be obtained prior to any screening tests/procedures for the research. The IRB considers the subject to be enrolled in the study as soon as the consent form is signed. The participant should be counted on Continuing Review reports, even if they are not eligible to continue in the study. After the screening visit, if you are eligible to continue in the study, you will return for [describe return visit]. (or) If you are eligible to receive the study treatment, you will return for [describe return visit].

Screening procedures are standard care: All of these screening tests would be done even if you do not take part in the research study. If you have had any of these tests performed recently within the time limitations set forth in the study, the results of the tests will be recorded and the tests will not be repeated for this study. These tests are routine for patients with your disease who are about to start therapy.

Pregnancy precautions: If you are pregnant or nursing, you will be excluded from participation in the study. If you are a sexually active woman of childbearing potential [if the drug affects sperm, also reference males: or a sexually active male], you must be willing to use an accepted method of birth control [list accepted methods, e.g., intrauterine device, birth control pills, condom, diaphragm or cervical cap].

Central venous catheter: You will have a central venous catheter (plastic tube) inserted by a surgeon or a radiologist. This device is similar to an IV but it is placed in a larger vein, usually under the collarbone or in the lower neck.

Single-blind, e.g., placebo run-in: At some time during this study, you will receive a placebo for [number of weeks], to discover what your illness is like without any treatment. The study doctor will know when this is happening. You will be watched closely during that time to make sure you are all right.

Bone marrow biopsy and aspiration: Bone marrow aspiration and biopsy involve inserting special needles into the hipbone and removing some of the marrow (soft tissue inside the bones that makes blood cells). Local anesthesia and/or IV sedation may be used by your doctor to keep you more comfortable during the procedure. Your doctor will discuss the procedure with you in detail and you will be asked to sign a separate consent form.

For research involving MRI scans: An MRI scanner takes pictures of the inside of your body by sending out a magnetic field and radio waves.

For rolling registration: A medication dose level between [low and high dosages] mg/m2 (based on the size of your body) will be assigned by the sponsor on a per patient basis. Your total dose level of [drug name] will be [dosage]. Initially, you will receive a test dose of either [number] percent of you total dose or [number] mg, whichever is smaller. If you tolerate this without any significant toxicity after [number] minutes, you will receive your total dose given into your vein at a rate of [number] mg/hr on days [number] and [number] of each monthly cycle.

Placebo washout period, single-blind: At some time during this study, you will be receiving a pill that looks like the study medication, but which contains an inactive substance instead. This is known as a placebo. The longest period of time that you would get the placebo and therefore not be getting any medication for your condition is [time].

Apheresis: Apheresis is the process which collects a type of blood cell called stem cells. Blood will be removed from you using your central catheter and passed through a machine. The machine will remove your stem cells and then return the remaining blood cells back to you through your central catheter. Collecting your stem cells will take about 4 to 6 hours a day. It usually takes 1 to 3 days to get enough cells for transplantation. Your stem cells will be frozen and stored. In the transplant phase of this study, these same stem cells will be returned to you. If enough stem cells are collected, you will continue to the transplant portion of this study. If not enough cells are collected, you will discontinue protocol treatment and your doctor will discuss other treatments with you.

Use of standard medications to prevent or treat side effects: While you are receiving these chemotherapy drugs you will receive standard medications at routine doses and routine supportive care in order to prevent or minimize side effects.

Standard care screening procedures: You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of your regular care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.

For research involving journal entries or questionnaires that are not reviewed in real time: The study is not meant to take the place of any medical or mental health treatment that you may want or need. During the study, we will not be monitoring the content of your journal entries/posts/questionnaires in real time. This means we will not be aware of any entries you make that could indicate health treatment is needed. If you are feeling depressed or suicidal, or are having difficulty coping, please contact your primary doctor or go to your local emergency room as soon as possible. (or)

The study is not meant to take the place of any medical or mental health treatment that you may want or need. The study team will monitor the content of your journal entries/posts/questionnaires [enter time interval] but will not be responding to any of the information in “real time.” This means we will not be immediately aware of any entries you make that could indicate health treatment is needed. If you are feeling depressed or suicidal, or are having difficulty coping, please contact your primary doctor or go to your local emergency room as soon as possible.

For research involving lumbar punctures: The lumbar pucture (LP) involves sticking a needle into the space around the spinal cord that is filled with cerebrospinal fluid (CSF). Before this needle is placed, an anesthetic will be injected to numb the area. Once the area is numb, the lumbar puncture needle will be placed and up to 15 ml or 1 tablespoon of CSF will be removed to [describe test]. The lumbar puncture takes about 30 minutes. After the lumbar puncture, you may be asked to lie flat on your back in the exam room for about one hour.

3. Discomfort and Risks

Risk of randomization in clinical trials: You will be assigned to a treatment program by chance. The treatment you receive may prove to be less effective or to have more side effects than the other research treatment(s) or other available treatments.

Risks of clinical or physical interventions: In addition to the risks described above, there may be unknown risks or risks that we cannot predict associated with being in this research. The investigators will let you know if they learn anything that might make you change your mind about participating in the research.

Risk of placebo in clinical trials: If you are in the group that receives placebo, your condition will go without active treatment for [length of time] and your symptoms may get worse.

For Phase 1 studies: In accord with the standard conduct of phase one studies of this kind, the dose of [drug] will be increased until people experience unacceptable side effects. It is impossible to predict all of the side effects that you might experience.

Central venous catheters: Insertion of central venous catheters may result in pain, bleeding, a punctured lung, decreased blood pressure or infection at the procedure site.

Bone marrow biopsy and aspiration: Bone marrow aspiration and/or biopsy may cause pain and tenderness at the needle insertion site. There may be some bruising, bleeding, or infection at the procedure site.

Risk of loss of confidentiality: There is a risk of loss of confidentiality if your medical information or your identity are obtained by someone other than the investigators, but precautions will be taken to prevent this from happening.

MRI discomforts and risks: Because the MRI scanner contains a very strong magnet, you may not be able to have the MRI if you have certain kinds of metal in your body (for example, a heart pacemaker, a metal plate, certain types of heart valves or brain aneurysm clips). Someone will ask you questions about this before you have the MRI. Having a MRI may mean some added discomfort to you. In particular, you may be uncomfortable inside the MRI scanner if you do not like to be in closed spaces (claustrophobia). You may also be bothered by the loud banging noise during the study. Temporary hearing loss has been reported from the loud noise. This is why you will be asked to wear earplugs. During the procedure, you will be able to talk with the MRI staff through a speaker system. You can tell them to stop the scan at any time.

Risks of standard venipuncture: The discomfort associated with removing blood by venipuncture (by needle from a vein) is a slight pinch or pin prick when the sterile needle enters the skin. The risks include mild discomfort and/or a black and blue mark at the site of puncture. Less common risks include a small blood clot, infection or bleeding at the puncture site, and on rare occasions fainting during the procedure.

Suggested pregnancy precautions: The risks to an unborn baby or a nursing child from the study drug are not known at this time. If you are pregnant or become pregnant, the study drug may cause problems to your unborn baby. Women who are pregnant or are nursing a child may not participate in this research study. If you are a female capable of becoming pregnant, a pregnancy test will be required before you begin the research. You must agree to take reasonable and necessary precautions against becoming pregnant during the period of the investigation. The investigator will discuss appropriate precautions with you. If at any point during the research you believe there is any possibility that you may be pregnant, you must notify the investigator immediately.

Contraceptive measures for men: The treatment used in this study could affect your sperm and could potentially harm a child that you may father while on this study. If you are sexually active, you must agree to use a medically acceptable form of birth control in order to be in this study. Medically acceptable contraceptives include: surgical sterilization or a condom used with a spermicide.

Risks of genetic research for inheritable diseases: (Note to investigators: Results of a validated genetic test may be given to subjects or placed in the medical record only if the test is performed in a CLIA-certified lab.) This study involves genetic research, which means we may find out that you are a carrier of a specific gene. We [will/will not] give you the results of the genetic studies being done for this research. We [will/will not] not put the results of the genetic studies in your medical record. We will not release information about you unless you authorize us to do so or unless we are required to do so by law. However, if you tell your family doctor or other health professional that you participated in this study, they could put such information into your medical record.

(If receiving the results of the genetic test is optional, include a sentence and a yes/no checkbox for subjects to indicate their choice. Also include whether or not genetic counseling would be available and who would pay for such counseling.)

For genetic research, the following language regarding the protections provided by the Genetic Information Nondiscrimination Act (GINA) may need to be included: There is a federal law, called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. (or)

The Genetic Information Nondiscrimination Act (GINA) may help protect you from health insurance or employment discrimination based on genetic information. The law provides that health insurance companies and group health plans:

  • May not ask for genetic information from this research; and
  • May not use genetic information when making decision about eligibility or premiums.

The law will not stop health insurance companies from using genetic information to decide whether to pay claims. The law does not apply to other types of insurance (such as: life, disability or long-term care).

Genetic testing risks: Although the results will not be returned to you, if you do obtain the research results, there may be a risk in knowing the results. For example, new health information about inherited traits that might affect you or your blood relatives could be found during a research study. Such information may affect how you or your family makes health decisions. In some cases, this information could be used to make it harder for you to get or keep a job or affect your insurance. For example, life insurance companies may charge a higher rate based on this information. There are laws against the misuse of genetic information, but they may not give full protection. The chance that your information could be misused is very small. We have many protections in place to lower this risk.

For research involving genetic materials: Genetic information is unique to you, even without your name or other identifiers. For this reason, genetic information like DNA may be used to identify you and possibly your family members. We have procedures (such as labeling your samples with a password-protected code known only to select research staff) to prevent people working with your DNA from discovering if it belongs to you. However, there is the risk this can happen as new ways of tracing genetic information are being developed that may make re-identification of genetic information possible.

Paternity incidental findings: You should also be aware that we may detect instances of non-paternity. For example, if a person you believe is your child is not actually your biological child, the testing may inadvertently detect this. You will not be informed of this, if it occurs.

Texting while driving risks: You should be aware that it is illegal in the Commonwealth of Pennsylvania to text while driving. It is also dangerous to pay attention to your cellular phone while driving, walking, or doing any activity that requires your attention. You should continue to exercise good judgment on this while participating in this study.

Data and Safety Monitoring Board: The Data and Safety Monitoring Board (DMSB), an independent group of experts, will be reviewing the information from this research throughout the study. If any important new information about the study develops that may affect your health, welfare or willingness to stay on the study, your study doctor will tell you. You may be asked to sign another consent form at that time.

For studies that use standard medications to prevent or treat side effects: You will receive standard medications to help prevent and control side effects. The study doctor can discuss the risks associated with these medications.

Informed consent document in medical record presents the risks: Your medical record will not hold any record of your participation in this genetic research. Your informed consent for the genetic research will be kept in a special, secure file, which is not part of your medical records.

Risks for testing for reportable diseases: If you decide to participate in this study, we will test you for [name of disease]. We will ask you to sign a separate consent form for this test. The results of the test could indicate that you have [name of disease]. If that happens, we will refer you to a doctor who specializes in treating [name of disease]. We will make every effort to keep your personal information confidential. However, we are required by law to report positive tests to the Pennsylvania Department of Public Health. Becoming aware of a diagnosis of [name of disease] could have serious personal and/or social consequences, including difficulty obtaining health insurance or employment. For more information about the risks of [name of disease] testing, please talk to your study doctor.

Peripheral stem cell collection for transplantation: Peripheral stem cell collection for transplantation may cause a decrease in your blood cell counts, including white blood cells (infection fighting cells), red blood cells (oxygen-carrying cells), and platelets (small structures in the blood that help it to clot). If your blood cell counts are decreased significantly, you may require transfusions of red blood cells or platelets. You will need to sign a separate consent for any blood cell transfusions. You may experience signs of low calcium in your blood, which could include sensations of numbness, prickling or tingling, abdominal discomfort and nausea and vomiting.

Eye exam: Drops will be put in your eyes to dilate your pupils. The drops may blur your vision and make you sensitive to light. The drops will wear off over several hours. There is a small risk of an allergic reaction to the drops. There is also a small risk that the drops could cause the eye pressure to increase. If this happens, it will be treated, but there is a small risk of losing vision from the pressure increase. Due to the blurring effect on your vision and possible light sensitivity, we suggest that you do not drive until the drops have worn off. If necessary, have someone come with you who can drive for you after the exam.

Risks of studies using depression scales: Some of the questionnaires and interview questions will be about your feelings, such as depression, sadness and anxiety. If your responses indicate that you are having suicidal thoughts or may be at risk of hurting yourself or others, we will need to respond to that. The response may involve breaking confidentiality and contacting a licensed mental health professional or a law enforcement officer. All patients who express any suicidal thoughts will be referred for follow-up mental health counseling.

For research involving interviews or questionnaires: You may get tired or bored when we are asking you questions or you are completing questionnaires. You do not have to answer any question you do not want to answer.

For research involving fMRI and incidental findings: You should not expect to get your results from the MRI scan since the scan done during this study is not designed to detect or evaluate any medical condition you may have. The MRI scan is intended solely for research purposes and will not provide the same detailed information as an MRI done for clinical reasons. There is a small chance that researchers could find something that might be important to your health. If this happens, a member of the study team may contact you to find out if you would like to learn more. However, even if we find something important to your health, we cannot guarantee that you will be contacted.

For general incidental findings: It is possible that the study procedures could detect a possible unknown medical problem that is unrelated to the purpose of this study. If the research procedures uncover findings that may be important for you to know about, such as the possibility of a previously unknown medical condition. If this happens, a member of the study team may contact you to find out if you would like to learn more. These findings may require additional testing or treatment. The cost of any additional tests or related treatment will be your responsibility.

For research involving lumbar punctures: Lumbar puncture is a standard procedure used in medical practice. When spinal fluid is removed during a lumbar puncture, the risks include headache, bleeding and pain at the site where the needle was put in, and infection. Pain during the lumbar puncture procedure will be prevented or minimized by using local anesthesia (lidocaine). Infection after a lumbar puncture is very rare, but serious, and would be treated with antibiotics.

About 1 out of 3 people who have a lumbar puncture develop a post-lumbar puncture headache. Headache can occur if the lining around the spinal fluid (dura) is torn and some of the fluid leaks out. Post-lumbar headaches are more common in females and in people less than 30 years old. This headache can be mild to severe. You may also have nausea, dizziness, and ringing in the ears.

If you develop a headache, you will need to lie down to reduce the headache pain and symptoms. Post-lumbar puncture headaches get worse when you are sitting or standing. Occasionally, the headache may be severe enough to interfere with your normal daily activities, such as going to work or school. If this happens, no payment will be made available to you for time missed from work or school or for others costs, such as paying for a babysitter.

If you get a headache, you should contact [name of principal investigator] at [phone number]. Pain medication will be given to you, if needed. If the headache lasts more than three days, a procedure called a blood patch may be performed. This procedure involves taking blood from your arm and injecting it in the same place where the spinal needle was put in during the lumbar puncture. The clotting of the blood in this space should stop further fluid leaking and stop the headache.

For studies using any type of Internet communication to collect, transmit or store research data: We will make reasonable efforts to protect the privacy of your information on social media. Each platform has their own privacy policies and terms of use that may change at any time. Penn State Health cannot guarantee the privacy and confidentiality of information shared on social media in this research study. You should never expect your information to remain private. Remember to regularly visit the site privacy policies and update your own privacy settings. If your child is using social media, remind them of proper use and how to stay safe. Social media retains information shared across accounts for an unknown length of time and it may be shared with others including targeted advertisers.

Although every reasonable effort has been taken, confidentiality during Internet communication activities cannot be guaranteed and it is possible that additional information beyond that collected for research purposes may be captured and used by others not associated with this study.

(When text messages are used for research purposes, the consent must include a warning to participants that text messages are not encrypted or secure during their transmission, and could be intercepted.)

4a. Possible Benefits to You

If subject is randomized: The potential benefit to you is that the treatment you receive may prove to be more effective than the other study treatment or than other available treatments, although this cannot be guaranteed. (or)

If you are in the group that receives [drug name], you may [describe any benefits that may reasonably be expected]. There is no guarantee that you will benefit from being in this research.

If there is no direct benefit: You will not benefit from taking part in this research study.

For Phase 1 oncology studies: (If the study involves NO therapeutic intent) The purpose of this study, as all phase one studies, is not to treat your cancer. This study is being done in the hope that it will provide information that will improve the treatment of people in the future. You will probably neither feel better nor live longer as a result of participating in this study.

(If the study includes a therapeutic intent, e.g., objective to evaluate efficacy) There may or may not be direct medical benefits to you from being in this research.

For research comparing/involving approved therapies: There is no guarantee that you will benefit from being in the research. The treatment you receive may even by harmful. Your doctor feels that your participation in this study will give you at least as good a result as you might expect from other treatments.

5.Other Options that Could be Used Instead of This Research

No suggested language is available for this section of the consent document.

6. Time Duration of the Procedures and Study

For studies where subject may remain on study treatment until disease progression: The exact length of time you will remain on the study will depend on how long you stay on treatment and if you are having side effects while receiving study treatment. Treatment with the study drug will continue as long as it is of benefit to you, you are not experiencing unacceptable side effects, and the study remains open.

7a. Statement of Confidentiality (Privacy and Confidentiality Measures)

For investigator-written research: If the principal investigator moves to another institution, your data and/or samples may be transferred to the new institution.

For research with Certificates of Confidentiality: (A COC is necessary if the research accrues personal information that may place the participants at risk of adverse consequences or damage their financial standing, employability, insurability or reputation. See suggested NIH consent language here.

For audio/video/photos: One aspect of this study involves making of you. [Describe why the recordings/photographs are being made, who has access to the recordings, how they are labeled and if or when the recordings/photographs will be destroyed. Depending on whether or not you would include the subject’s data in the study they refused to be recorded/photographed, choose one of the following two statements to add to this section.]

(If audio or video recording/photographs is optional, i.e., you would still enroll the subject in the study if they refused to be recorded/photographed) You should initial below to indicate your preferences regarding the optional . You give permission to [make/take] during this study. [Insert yes/no options]

(If audio or video recording is required as part of the study, i.e., you simply would not enroll the subject in the study if they did not want to be recorded) Your initials here indicate that you know that of you will be [made/taken] during this study.

For studies focusing on violence, abuse or self-inflicted injury: We will disclose to the proper authority any information you share with us concerning child abuse, child sexual abuse, or harming yourself or others.

For studies using HMC labs for drug testing: The results of your laboratory tests that are performed in the Penn State Health Milton S. Hershey Medical Center (HMC) clinical laboratory, including the urine screen for illegal substances, will become part of your permanent medical record here at HMC. This urine drug screening includes tests for marijuana, amphetamines, barbiturates, benzodiazepines, cocaine and opiates. Because this information becomes part of your medical record, complete confidentiality cannot be guaranteed. If you do not want these test results included in your medical record, you should not participate in this study.

8. Costs for Participation

No costs covered by the research: All of the tests or procedures are routine for patients receiving treatment for [name of disease]. The schedule for these tests is the same as the standard of care you would receive if you did not participate in this study. Either you or your insurance company will be responsible for all physician, laboratory, and hospital costs. All of the drugs used in the study have been approved by the FDA and are commonly available.

Sponsor covering cost of study drug: The sponsor will provide [study drug] at no cost to you. Although the study drug is provided at no cost, there may be costs for drug preparation and administration. You or your insurance company will be responsible for the normal costs related to your disease.

All costs covered: There is no cost to you for participating in this study. There will be no charge for any procedures or drugs required by the study.

Some costs covered: The study drug will be provided at no cost by the study sponsor. Although the study drug is provided at no cost, there may be costs for drug preparation and administration. Taking part in this study may lead to added costs to you or your insurance company. You or your insurance company will be responsible for the normal costs related to your disease. You should ask the research team about these costs. (or)

You will not be charged, nor will your insurance carrier be charged, for any test or visit that is completed solely for the purpose of this study. The tests you will not be charged for include [list of tests]. The parts of your care that would normally be done as standard treatment, such as [list], will be billed to your insurance company.

High-cost treatments: The cost of being in this study could be high; therefore, you should discuss these costs with the study doctor or your insurance company before agreeing to be in this study. You or your insurance company will have to pay for the cost of being in the study. Please tell the study doctor if you would like to talk to a financial counselor who will assist you in managing these costs.

9. Compensation for Participation

If participants are not reimbursed: You will not receive any compensation for being in this research study.

10. Research Funding

For funding disclosure: The institution will be reimbursed by the research sponsor, [sponsor name], for use of this site’s facilities and for the work the research staff does to conduct this research. No one on the research team will receive a direct payment or an increase in salary for conducting this study.

For disclosure of financial conflicts of interest:

If Penn State has ownership, consultative or financial relationships with the sponsor:

(Penn State holds a patent) Research studies like the one you are thinking about joining are done to determine whether the new [test, drug, treatment] is safe and effective. Penn State [owns/has applied for] a patent on the new [test, drug, treatment]. If research shows the new [test, drug, treatment] is safe and effective, Penn State would receive a part of the profits from any sales of this [test, drug, treatment].

The Institutional Review Board at Penn State College of Medicine has reviewed the possibility of financial benefit. If you would like more information, please ask the investigators or the study coordinator.

(Penn State owns equity) This research study is designed to test a product made by [sponsor]. Penn State has an investment in [sponsor], such as stock. The financial value of this investment might be affected by the results of this study. This means that Penn State could gain or lose money depending on the results of this study.

The Institutional Review Board at Penn State College of Medicine has reviewed the possibility of financial benefit. If you would like more information, please ask the investigators or the study coordinator.

11. Voluntary Participation

For clinical research that does not prohibit participation in other clinical studies: If you will be in another clinical research study at Hershey Medical Center or elsewhere while in this research, you should discuss the procedures and/or treatments with your physician or the study doctors. This precaution is to protect you from possible side effects from interactions of research drugs, treatments or testing.

For long-term follow-up: In the event that you complete or stop treatment, you will continue to be followed and medical information will continue to be collected from your medical records in a confidential manner. If you withdraw completely from the study, no further information will be collected and your participation will end. You may discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled.

For studies with data safety monitoring boards: A Data Monitoring Committee, an independent group of experts, will be reviewing the results from this research throughout the study. You will be told about any new information from this or other studies that may affect your health, welfare, or willingness to stay in this study.

12. Contact Information for Questions or Concerns

Please provide the appropriate contact information in this section of the consent document.

Miscellaneous Topics

Neuropsychological feedback: You may receive the results of your neuropsychological testing and you may give permission for your primary care physician to receive these results if you wish. This testing is done for research purposes only and is not to be considered for clinical diagnosis. This neurocognitive assessment conducted as part of this study does not replace a comprehensive neuropsychological evaluation and is not related to your clinical care.

Would you like to be provided with a report of your neuropsychological testing done for research in this study? [include yes/no options]

Would you like your primary physician to receive the results of your neuropsychological testing done for research in this study? [include yes/no options]

Future research testing on specimens: It is unlikely that the research testing on specimens might uncover findings that may affect your current or future health. If this unlikely event occurs, the researchers will try to contact your doctor about what the research tests might mean. Only the doctor will be notified and the information will not become part of your medical record. It will remain confidential. Your doctor may discuss this unexpected finding with you. Your doctor may recommend consultation with a genetic counselor or repeat testing since the findings came from a basic research laboratory and need to be confirmed in a clinically certified laboratory. It is possible that your doctor may recommend that no additional action is necessary.

For research involving optional storage of tissue for future research:

(Optional storage of tissue for future research) In the main part of this study, we are collecting [list tissue and/or blood and/or cells] from you. If you agree, [researchers and/or sponsor name] would like to keep your leftover sample(s) and health information for future research studies.

  • These future studies may be helpful in understanding [list disease/condition] and other diseases.
  • It is unlikely that these studies will have a direct benefit to you.
  • The results of these tests will not have an effect on your care.
  • Neither your doctor nor you will receive results of these future research tests, nor will the results be put in your health record.
  • Sometimes tissue is used for genetic research about diseases that are passed on in families. Even if your sample(s) [is/are] used for this kind of research, the results will not be put in your health record.

For linked samples: Your leftover samples will be labeled with [list all identifiers that apply: “a code number,” “your initials,” etc.].

  • These samples will be stored [describe how the samples will be secured].
  • The length of time they will be used is unknown.
  • You will be free to change your mind at any time.
  • If you change your mind, you should contact [principal investigator] and let them know you wish to withdraw your permission for your [list tissue and/or blood and/or cells] to be used for future research. Any unused [list tissue and/or blood and/or cells] will be destroyed and not used for future research studies.

For unlinked samples: Your samples will not be labeled with any of your personal information, such as your name or a code number. They will be available for use in future research studies indefinitely and cannot be removed due to the inability to identify them.

You should initial below to indicate what you want regarding the storage of your leftover [list tissue and/or blood and/or cells] and related health information for future research studies.

  • Your sample(s) and related health information may be stored and used for future research studies about health problems. [include yes/no options]
  • Your sample(s) and/or related health information may be shared without any identifying information with other investigators/groups (including investigator/groups outside of Penn State/Penn State Health) and/or scientific databases (including databases maintained by Penn State/Penn State Health, the federal government, and/or private companies and other institutions). [include yes/no options]

IRB/HSPO Details

IRB Overview Expand answer

The Institutional Review Board consists of independent committees established to protect the rights and welfare of human subjects involved in research at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.

The IRBs evaluate proposed new research and conduct review of ongoing research following guiding ethical principles, applicable regulations and institutional requirements. The fundamental ethical principles are outlined in The Belmont Report, which forms the basis for U.S. federal regulations for the protection of human subjects of research.

The Investigators’ Manual found in the CATS IRB Library under the “General” tab provides an extensive list of answers to questions about the requirements for conducting research at Penn State. The Penn State College of Medicine research guidebook is also a good resource.

When Does the IRB Need to Review a Project? Expand answer

Penn State relies on the IRB to make this assessment due to the complexity of the rules. Call the Human Subjects Protection Office (HSPO) at 717-531-5687 to consult with an IRB analyst. The Federal OHRP Human Subject Protections Decision Charts may help you prepare for questions that will need to be addressed to make this determination.

What is the Definition of Human Research? Expand answer

See the IRB SOP HRP-001 Definitions, available in the CATS IRB Library under Standard Operating Procedures, which defines Human Research and provides other definitions followed by the human research protection program.

Are There Fees for Regulatory Compliance Review? Expand answer

A regulatory compliance fee is accessed to support the activities of the Human Subjects Protection Office, the Office of Research Affairs, the Clinical Trials Office and other research support functions. The fee is based on the type of IRB review required (e.g., convened committee or noncommittee review, continuing review, amendment, etc.).

For details, call the Clinical Trials Office at 717-531-3779.

Scientific Review Requirements Expand answer

All investigator-written human research studies must undergo a scientific review to meet institutional requirements.

  • Investigator-written human research studies requiring committee review by the convened IRB must provide documentation of scientific review with the IRB submission.
  • Investigator-written human research studies qualifying for expedited review may also require scientific review at the discretion of the IRB. If scientific review has not already occurred for an expedited study, the investigator will be notified of the requirement during the IRB review process if applicable.

The scientific review requirement may be fulfilled by one of the following.

External Peer-Review Process

This method includes research studies funded by an NIH grant and studies that have undergone a formal review by the FDA for an IND number. (Note: This process does not include studies that have undergone FDA exemption determinations.)

Department or institute scientific review committees

These departments/institutes have a scientific review process:

  • Anesthesiology and Perioperative Medicine
  • Cancer Institute
  • Family and Community Medicine
  • Neurosurgery
  • Neurology
  • Obstetrics and Gynecology
  • Psychiatry
  • Radiology

Scientific review by the Clinical Research Center (CRC) Advisory Committee

This method should be used by investigators from departments without a scientific review process.

  • This committee meets the first Wednesday of each month.
  • Complete applications must be received by the 25th of the month to be included on the next month’s agenda.
  • See the Application for Scientific Review for additional information and instructions.
  • When making the IRB submission, under Supporting Documents, upload the Preliminary Scientific Review Checklist signed by the Advisory Committee Chair/Acting Chair as documentation of scientific review.
Posting of Informed Consents for NIH-Funded Clinical Trials Expand answer

Learn more about where informed consent forms for NIH-funded clinical trials are to be posted on the NIH website.

Security and Integrity of Human Research Data Expand answer

Penn State College of Medicine investigators are responsible for disclosing the nature of the confidential data they collect for research, and for preparing a data security and integrity plan in accordance with the appropriate security category requirements listed in the SOP Addendum: Security and Integrity of Human Research Data, available in the CATS IRB Library.

Investigators must coordinate with the Office of Research Affairs to establish a data transfer agreement or material transfer agreement if data and/or human specimens are to be shared with a third party. For all research involving human research data, a data security and integrity plan must be submitted to the IRB as part of the initial IRB application.

The IRB reviews the data security and integrity plan during initial review. If review by the IT Security Group is required, an ancillary review activity is set in the IRB database system and approval of the study is granted after the IT Security Group has approved the study’s security and integrity plan. The approval memo for the study confers the final approval of the data security and integrity plan by the IRB. For exempt research involving human research data, the exemption determination memo confers acceptance of the data security and integrity plan by the IRB.

College of Medicine Research Support Resources Expand answer
  • Consultations – Penn State Clinical and Translational Science Institute offers consultations in biostatistics, regulatory and ethics issues and more.
  • Research Guidebook – The College of Medicine clinical research guidebook offers a step-by-step walkthrough of the clinical research process.
  • Clinical Trials Office – The Clinical Trials Office supports clinical research across the College and Penn State Health Milton S. Hershey Medical Center.
  • Cancer Institute Clinical Trials Office – This office provides support for cancer-specific clinical trials.
  • Clinical Research Center – Clinical Research Centers in Hershey and University Park provide research infrastructure for investigators who conduct research with human subjects.
  • REDCap – REDCap (Research Electronic Data Capture) is a secure, web-based application for databases and online surveys for research purposes.
  • Clinical Trial Monitoring – As part of the data management services offered by the Department of Public Health Sciences, clinical trial monitoring can be provided for IND/IDE, multi-site and high-risk clinical trials.
Read More About Human Subjects Protection Expand answer

Ethical principles of human subjects protection

Federal agencies

General

“Common Rule” agencies

National Institutes of Health (NIH) details

Federal regulations for the protection of human research subjects

Registration of clinical trials