Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu).
Name:
Department:
Telephone:
E-mail Address:
Provide a version date for this document. This date must be updated each time this document is submitted to the IRB office with revisions. DO NOT revise the version date in the footer of this document.
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual”, under “ClinicalTrials.gov” for more information.
Important Instructions for Using This Protocol Template:
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the IRB to determine whether a study meets all applicable criteria for approval.
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in the guides available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes.
Update the Version Date on page 1 each time this document is submitted to the IRB office with revisions.
If you need help…
All locations:
Human Research Protection Program
Office for Research Protections
101 Technology Center
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
Describe the purpose, specific aims, or objectives.
The purpose of this study is to investigate knowledge about Open Science and its practices among graduate students, postdocs, teaching faculty, research staff, research faculty, and administrators. Open Science is a growing movement to make research more transparent, to share data and code, and to publish in venues that are accessible to all. We aim to understand what our colleagues at Penn State know about Open Science as practiced in their fields. We are also interested in learning what barriers respondents find in their adoption of these practices.
[Type protocol text here]
State the primary endpoints to be measured in the study.
Research typically has a primary objective or endpoint. Additional objectives and endpoints are secondary. The endpoints (or outcomes), determined for each study subject, are the quantitative measurements required by the objectives. Measuring the selected endpoints is the goal of a trial (examples: response rate and survival).
[Type protocol text here or indicate as not applicable]
State the secondary endpoints to be measured in the study.
[Type protocol text here or indicate as not applicable]
Describe the scientific background and gaps in current knowledge. For clinical research studies being conducted at Penn State Health/Penn State College of Medicine, and for other non-PSH locations as applicable, describe the treatment/procedure that is considered standard of care (i.e., indicate how patients would be treated in non-investigational setting); and if applicable, indicate if the study procedure is available to patient without taking part in the study.
[Type protocol text here]
Describe any relevant preliminary data.
[Type protocol text here]
Provide the scientific rationale for the research.
[Type protocol text here]
Create a numbered list below in sections @ref(inclusion-criteria) and @ref(exclusion-criteria) of criteria subjects must meet to be eligible for study enrollment (e.g., age, gender, diagnosis, etc.).
Vulnerable Populations:
You MAY NOT include members of these populations as subjects in your research unless you indicate this in your inclusion criteria because specific regulations apply to studies that involve vulnerable populations.
The checklists referenced below outline the determinations to be made by the IRB when reviewing research involving these populations. Review the checklists as these will help to inform your responses throughout the remainder of the protocol.
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Create a numbered list of the inclusion criteria that define who will be included in your final study sample (e.g., age, gender, condition, etc.)
[Type protocol text here]
[ ] No [ ] Yes – identify the countries where data collection will take place
[Type protocol text here]
Create a numbered list of the exclusion criteria that define who will be excluded in your study.
[Type protocol text here]
Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol requirements, subject consent withdrawal, disease progression, etc.).
[Type protocol text here or indicate as not applicable]
Describe when and how to withdraw subjects from the study; the type and timing of the data to be collected for withdrawal of subjects; whether and how subjects are to be replaced; the follow-up for subjects withdrawn from investigational treatment.
[Type protocol text here or indicate as not applicable]
[Do not type here]
Describe the source of subjects and the methods that will be used to identify potential subjects (e.g., organizational listservs, established recruitment databases, subject pools, medical or school records, interactions during a clinic visit, etc.). If not recruiting subjects directly (e.g., database query for eligible records or samples) state what will be queried, how and by whom.
StudyFinder:
For Penn State Health submissions using Enterprise Information Management (EIM) for recruitment, and for non-Hershey locations as applicable, attach your EIM Design Specification form in CATS IRB (http://irb.psu.edu). See “HRP-103- Investigator Manual, Study Recruitment” for additional information.
DO NOT include the actual recruitment material or wording in this protocol.
[Type protocol text here]
Describe how potential subjects first learn about this research opportunity or indicate as not applicable if subjects will not be prospectively recruited to participant in the research. Subject recruitment can involve various methods (e.g., approaching potential subjects in person, contacting potential subjects via email, letters, telephone, ResearchMatch, or advertising to a general public via flyers, websites, StudyFinder, newspaper, television, and radio etc.). DO NOT include the actual recruitment material or wording in this protocol.
[Do not type here]
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[ ] Eligibility screening is occurring before consent2 [ ] Eligibility screening is occurring after consent [ ] Consent is not being obtained in this research [ ] Not applicable - Eligibility screening is not being done in this research.
[Type protocol text here]
Refer to the following materials: - The “HRP-090- SOP - Informed
Consent Process for Research” outlines the process for obtaining
informed consent.
- The “HRP-091– SOP - Written Documentation of Consent” describes how
the consent process will be documented. - The “HRP-314- Worksheet -
Criteria for Approval” section 7 lists the required elements of consent.
- The “HRP-312- Worksheet - Exemption Determination” includes
information on requirements for the consent process for exempt research.
In addition, the CATS IRB Library contains consent guidance and
templates for exempt research. - The CATS IRB library contains various
consent templates for expedited or full review research that are
designed to include the required information. - Add the consent
document(s) to your study in CATS IRB (http://irb.psu.edu). Links to Penn State’s consent
templates are available in the same location where they are uploaded. DO
NOT include the actual consent wording in this protocol.
[Do not type here]
Check all applicable boxes below:
[ ] Informed consent will be sought and documented with a written consent form [Complete Sections @ref(obtaining-consent) and @ref(consent-other); If this is the only box checked, mark Sections @ref(#waive-doc), @ref(altered-consent) and @ref(no-consent) as ‘Not applicable’]
[ ] Implied or verbal consent will be obtained – subjects will not sign a consent form (waiver of written documentation of consent) [Complete Sections 5.2, 5.3 and 5.6; If this is the only box checked, mark Sections 5.4 and 5.5 as ‘Not applicable’]
[ ] Informed consent will be sought but some of the elements of informed consent will be omitted or altered (e.g., deception). [Complete section @ref(obtaining-consent), @ref(altered-consent) and @ref(consent-other); If this is the only box checked, mark Section @ref(no-consent) as ‘Not applicable’]
[ ] Informed consent will not be obtained – request to completely waive the informed consent requirement. [Complete Section @ref(no-consent); If this is the only box checked, mark Sections @ref(obtaining-consent), @ref(waive-doc), @ref(altered-consent) and @ref(consent-other) as ‘Not applicable’]
[ ] Exempt Research: If you believe that the research activities outlined meet one or more of the criteria outlined in “HRP-312- Worksheet- Exemption Determination”, check this box. By checking this box, you are verifying that the exempt consent process will disclose the following: Penn State affiliation; name and contact information for the researcher and advisor (if the researcher is a student); the activities involve research; the procedures to be performed; participation is voluntary; that there are adequate provisions to maintain the privacy interests of subjects and the confidentiality of the data.
If the research includes the use of student educational records include the following language in this section: The parent or eligible student will provide a signed and dated written consent that discloses: the records that may be disclosed; the purpose of the disclosure; the party or class of parties to whom the disclosure may be made; if a parent or adult student requests, the school will provide him or her with a copy of the records disclosed; if the parent of a student who is not an adult so requests, the school will provide the student with a copy of the records disclosed.
Note: If this box has been checked, mark Sections @ref(waive-doc), @ref(altered-consent), (no-consent), and @ref(consent-other) as “Not applicable.” If the investigator’s assessment is inaccurate, an IRB Analyst will request revision to the protocol and ask that consent forms and recruitment materials be submitted. Except for exemptions where Limited IRB Review is required (see “HRP-312- Worksheet- Exemption Determination”) or where otherwise requested by the IRB, consent forms and recruitment materials are generally not reviewed nor approved by the PSU HRPP for research undergoing exempt review.
Describe where and when the consent process will take place.
[Type protocol text here]
Describe the steps that will be taken to minimize the possibility of coercion or undue influence in the consent process.
[Type protocol text here]
Review “HRP – 411 – Checklist – Waiver of Written Documentation of Consent.”
[ ] The research presents no more that minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
OR
[ ] The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern. (Note: This condition is not applicable for FDA-regulated research. If this category is chosen, include copies of a consent form and /or parental permission form for participants who want written documentation linking them to the research.)
OR
[ ] If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. (Note: This condition is not applicable for FDA-regulated research.)
For distinct cultural groups, describe the alternative mechanism for documenting that informed consent was obtained.
[Type protocol text here]
[Type protocol text here or indicate as not applicable]
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided sufficient information.
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
Explain whether and how subjects will be debriefed after participation in the study. If subjects will not be debriefed, provide a justification for not doing so. Add any debriefing materials to the study in CATS IRB.
[Type protocol text here or indicate as not applicable]
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided sufficient information.
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
Explain if subjects will be provided with additional pertinent information after participation.
[Type protocol text here or indicate as not applicable]
Indicate what language(s) other than English are understood by prospective subjects or representatives.
If subjects who do not speak English will be enrolled, describe the process to ensure that the oral and written information provided to those subjects will be in that language. Indicate the language that will be used by those obtaining consent.
Indicate whether the consent process will be documented in writing with the long form of the consent documentation or with the short form of the consent documentation. Review “HRP-091 –SOP- Written Documentation of Consent” and “HRP-103 -Investigator Manual” to ensure that you have provided sufficient information.
[Type protocol text here or indicate as not applicable]
Refer to “HRP-417 -CHECKLIST- Cognitively Impaired Adults” for information about research involving cognitively impaired adults as subjects.
Describe the process to determine whether an individual is capable of consent.
[Type protocol text here or indicate as not applicable]
Describe whether and how informed consent will be obtained from the legally authorized representative. Describe who will be allowed to provide informed consent. Describe the process used to determine these individual’s authority to consent to research.
For research conducted in the state of Pennsylvania, review “HRP-013 -SOP- Legally Authorized Representatives, Children and Guardians” to be aware of which individuals in the state of Pennsylvania meet the definition of “legally authorized representative.”
For research conducted outside of the state of Pennsylvania, provide information that describes which individuals are authorized under applicable law to consent on behalf of a prospective subject to their participation in the procedure(s) involved in this research. One method of obtaining this information is to have a legal counsel or authority review your protocol along with the definition of “children” in “HRP-013 -SOP- Legally Authorized Representatives, Children, and Guardians.”
[Type protocol text here or indicate as not applicable]
Describe the process for assent of the subjects. Indicate whether assent will be required of all, some, or none of the subjects. If some, indicate which subjects will be required to assent and which will not.
If assent will not be obtained from some or all subjects, provide an explanation of why not.
[Type protocol text here or indicate as not applicable]
Describe whether and how parental permission will be obtained. If permission will be obtained from individuals other than parents, describe who will be allowed to provide permission. Describe the process used to determine these individual’s authority to consent to each child’s general medical care.
For research conducted in the state of Pennsylvania, review “HRP-013-SOP- Legally Authorized Representatives, Children and Guardians” to be aware of which individuals in the state of Pennsylvania meet the definition of “children.”
For research conducted outside of the state of Pennsylvania, provide information that describes which persons have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which research will be conducted. One method of obtaining this information is to have a legal counsel or authority review your protocol along with the definition of “children” in “HRP-013-SOP- Legally Authorized Representatives, Children, and Guardians.”
[Type protocol text here or indicate as not applicable]
Indicate whether assent will be obtained from all, some, or none of the children. If assent will be obtained from some children, indicate which children will be required to assent. When assent of children is obtained describe whether and how it will be documented.
[Type protocol text here or indicate as not applicable]
Data collection materials that will be seen or used by subjects in your study must be uploaded to CATS IRB (http://irb.psu.edu). DO NOT include any actual data collection materials in this protocol (e.g., actual survey or interview questions)
[Do not type here]
Describe and explain the study design.
[Type protocol text here]
Provide a step by step description of all research procedures being conducted (broken down by visit, if applicable) including such information as below (where and when applicable); describe the following: - HOW: (e.g., data collection via interviews, focus groups, forms such as surveys and questionnaires, medical/school records, audio/video/digital recordings, photographs, EKG procedures, MRI, mobile devices such as electronic tablets/cell phones, observations, collection of specimens, experimental drug/device testing, manipulation of behavior/use of deception, computer games, etc.) - WHERE: (e.g., classrooms, labs, internet/online, places of business, medical settings, public spaces, etc.)
[Type protocol text here]
[Type protocol text here]
[Type protocol text here]
[Type protocol text here]
Indicate the maximum number of subjects to be accrued/enrolled. Distinguish between the number of subjects who are expected to be enrolled and screened, and the number of subjects needed to complete the research procedures if applicable (i.e., numbers of subjects excluding screen failures.)
[Type protocol text here]
If applicable, provide a justification of the sample size outlined in section 8.1 to include reflections on, or calculations of, the power of the study.
[Type protocol text here or indicate as not applicable]
Describe the statistical methods (or non-statistical methods of analysis) that will be employed.
[Type protocol text here]
This section is required when research involves more than Minimal Risk to subjects as defined in “HRP-001 SOP- Definitions.”
Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For research involving prisoners, Minimal Risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Please complete each section below if the research involves more than minimal risk to subjects or indicate not applicable.
[Do not type here]
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to determine whether subjects remain safe.
[Type protocol text here or indicate as not applicable]
Describe the data that are reviewed, including safety data, untoward events, and efficacy data.
[Type protocol text here or indicate as not applicable]
Describe the method by which the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls and with subjects).
[Type protocol text here or indicate as not applicable]
Describe the frequency of data collection, including when safety data collection starts.
[Type protocol text here or indicate as not applicable]
Identify the individuals who will review the data. The plan might include establishing a data and safety monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor.
[Type protocol text here or indicate as not applicable]
Describe the frequency or periodicity of review of cumulative data.
[Type protocol text here or indicate as not applicable]
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring.
[Type protocol text here or indicate as not applicable]
Describe any conditions that trigger an immediate suspension of research.
[Type protocol text here or indicate as not applicable]
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the subjects’ participation in the research. Include as may be useful for the IRB’s consideration, a description of the probability, magnitude, duration, and reversibility of the risks. Consider all types of risk including physical, psychological, social, legal, and economic risks. Note: Loss of confidentiality is a potential risk when conducting human subject research and must be listed here. - If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. - If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become pregnant. - If applicable, describe risks to others who are not subjects.
[Type protocol text here]
Describe the potential benefits that individual subjects may experience from taking part in the research. If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. Compensation should be addressed in section 13.0.
[Type protocol text here or indicate “none” if there is no direct benefit to subjects]
Describe the potential benefits to society or others.
[Type protocol text here]
Describe the amount, type (cash, check, gift card, other) and timing of any subject payment or travel reimbursement. If there is no subject payment or travel reimbursement, indicate as not applicable.
Extra or Course Credit: Describe the amount of credit and the available alternatives. Alternatives should be equal in time and effort to the amount of course or extra credit offered. It is not acceptable to indicate that the amount of credit is to be determined or at the discretion of the instructor of the course.
Approved Subject Pool: Indicate which approved subject pool will be used; include in response below that course credit will be given and alternatives will be offered as per the approved subject pool procedures.
[Type protocol text here or indicate as not applicable]
Describe any costs that subjects may be responsible for because of participation in the research.
[Type protocol text here or indicate as not applicable]
Describe any costs that subjects may be responsible for because of participation in the research.
[Type protocol text here or indicate as not applicable]
Describe any approvals that will be obtained prior to commencing the research (e.g., from engaged cooperating institutions IRBs who are also reviewing the research and other required review committees, community leaders, schools, research locations where research is to be conducted by the Penn State investigator, funding agencies, etc.).
[Type protocol text here or indicate as not applicable]
DO NOT ALTER OR DELETE: Ancillary reviews are reviewed by other compliance groups or individuals within Penn State that inform the IRB’s review of a new study or a modification to an existing study.
PSU IRB may set applicable ancillary reviews for your study. Please refer to the “HRP-309 Worksheet – Ancillary Review Matrix” for more information (found in the CATS Library).
[Do not type here]
If this is a multi-site study (i.e., a study in which two or more institutions coordinate, with each institution completing all research activities outlined in a specific protocol) and the Penn State PI is the lead investigator, describe the processes to ensure communication among sites in the sections below.
[Do not type here]
List the name and location of all other participating sites. Provide the name, qualifications and contact information for the principal investigator at each site and indicate which IRB will be reviewing the study at each site.
[Type protocol text here or indicate as not applicable]
Describe the plan for regular communication between the overall study director and the other sites to ensure that all sites have the most current version of the protocol, consent document, etc. Describe the process to ensure all modifications have been communicated to sites. Describe the process to ensure that all required approvals have been obtained at each site (including approval by the site’s IRB of record). Describe the process for communication of problems with the research, interim results, and closure of the study.
[Type protocol text here or indicate as not applicable]
Describe the process and schedule for data submission and provide the data security plan for data collected from other sites. Describe the process to ensure all engaged participating sites will safeguard data as required by local information security policies.
[Type protocol text here or indicate as not applicable]
Describe the procedures for coordination of subject enrollment and randomization for the overall project.
[Type protocol text here or indicate as not applicable]
Describe how adverse events and other information will be reported from the clinical sites to the overall study director. Provide the timeframe for this reporting.
[Type protocol text here or indicate as not applicable]
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any on-site auditing and monitoring plans for the study.
[Type protocol text here or indicate as not applicable]
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board (IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) experienced by a subject or other individual, which in the opinion of the investigator is determined to be (1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be submitted to the IRB in accordance with the IRB policies and procedures.
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related documents (e.g., source documents, regulatory documents, data collection instruments, study data etc.). The investigator will ensure the capability for inspections of applicable study-related facilities (e.g., pharmacy, diagnostic laboratory, etc.).
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined research, please describe this process in the sections below. This information should not conflict with information provided in section 22 below OR the “HRP-598 – Research Data Plan Review Form” regarding whether or not data and/or specimens will be associated with identifiers (directly or indirectly). If there are no plans to use identifiable data/specimens for future, undetermined research, then this section is NOT applicable.
[Do not type here]
Identify what data and/or specimens will be stored, and the data associated with each specimen.
[Type protocol text here or indicate as not applicable]
Identify the location where the data and/or specimens will be stored.
[Type protocol text here or indicate as not applicable]
Identify how long the data and/or specimens will be stored. If data and/or specimens will be stored indefinitely, indicate such.
[Type protocol text here or indicate as not applicable]
Identify who will have access to the data and/or specimens.
Describe the procedures to release the data and/or specimens, including: the process to request a release, approvals required for release, who can obtain data and/or specimens, and the data to be provided with the specimens.
[Type protocol text here or indicate as not applicable]
Describe the process for returning results about the use of the data and/or specimens.
[Type protocol text here or indicate as not applicable]
List relevant references in the literature which highlight methods, controversies, and study outcomes.
[Type protocol text here or indicate as not applicable]
IMPORTANT: The following section is required for all locations EXCEPT Penn State Health and the College of Medicine. Penn State Health and College of Medicine should skip this section and complete “HRP-598 Research Data Plan Review Form.” In order to avoid redundancy, for this section state “See the Research Data Plan Review Form” if you are conducting Penn State Health research. Delete all other sub-sections of section 22.
For research being conducted at Penn State Health or by Penn State Health researchers only: The research data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form.”
In order to avoid redundancy, for this section state “See the Research Data Plan Review Form” if you are conducting Penn State Health research. Delete all sub-sections of section 22.
[For all other research]: Complete the following section. Please refer to PSU Policy AD95 for information regarding information classification and security standards and requirements. It is recommended that you work with local IT staff when planning to store, process, or access data electronically to ensure that your plan can be carried out locally and meets applicable requirements. If you have questions about Penn State’s Policy AD95 or standards or need a consultation regarding data security, please contact Penn State IT – Information Security at security@psu.edu.
| Hard Copy Data | Electronic Stored Data | |
|---|---|---|
| Names and/or initials (including on signed consent documents) | [ ] | [ ] |
| All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes | [ ] | [ ] |
| All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older | [ ] | [ ] |
| Telephone numbers | [ ] | [ ] |
| Fax numbers | [ ] | [ ] |
| Electronic mail addresses | [ ] | [ ] |
| Social security numbers | [ ] | [ ] |
| Medical record numbers | [ ] | [ ] |
| Health plan beneficiary numbers | [ ] | [ ] |
| Account numbers | [ ] | [ ] |
| Certificate/license numbers | [ ] | [ ] |
| Vehicle identifiers and serial numbers, including | [ ] | [ ] |
| license plate numbers | ||
| Device identifiers and serial numbers | [ ] | [ ] |
| Web Universal Resource Locators (URLs) | [ ] | [ ] |
| Internet Protocol (IP) address numbers | [ ] | [ ] |
| Biometric identifiers, including finger and voice prints | [ ] | [ ] |
| Full face photographic images and any comparable images | [ ] | [ ] |
| Any other unique identifying number, characteristic, or code (such as the pathology number) | [ ] | [ ] |
| Study code number with linking list | [ ] | [ ] |
| Genomic sequence data | [ ] | [ ] |
| State ID numbers | [ ] | [ ] |
| Passport numbers | [ ] | [ ] |
| Driver’s license numbers | [ ] | [ ] |
[Type protocol text here or indicate as not applicable]
[Type protocol text here or indicate as not applicable]
[ ] Penn State-provided database application. Check which of the following database applications are being used (check all that apply): - [ ] Penn State REDCap - [ ] Other – Specify - provided and approved database application:
[ ] Penn State, College, or Department IT file server
[ ] Penn State OneDrive or SharePoint
[ ] Penn State GoogleDrive
[ ] Web-based system provided by the sponsor or cooperative group - Specify URL and contact information:
[ ] Other – Specify the database application or server:
Please visit datastoragefinder.psu.edu for assistance with identifying appropriate data storage options. If the software to be used does not appear on that site, a software request form must be completed.** If there is a list/key that links indirect identifiers (code numbers, participant IDs, etc.) to direct identifiers, that list must not be comingled (i.e., stored in the same location) as the identifiable data, including copies of signed informed consent forms. Additionally, access to that list/key must be restricted to authorized project personnel.
[ ] Yes - explain how the list that links the code to identifiers is stored separately from coded data.
The identifiers will be provided voluntarily by respondents and are linked to their survey responses as long as the identifiers are stored by the researchers.
[ ] Not applicable, there is no list that links code numbers to identifiers. Skip to section 22.6.
[ ] Yes – explain how access to that list is restricted and why certain persons require access.
The PI and co-investigators on the IRB protocol will have access to the data.
[ ] No – explain why not:
[ ] Password-protected files [ ] Role-based security
Specify all other mechanisms used to ensure only permitted users have access to the stored research data:
The use of mobile devices or wireless activity trackers to collect identifiable research data may have to be approved by Penn State IT - Information Security.
[ ] No – skip to 22.8
[ ] Yes - answer the following questions:
[ ] Supplied by the sponsor
[ ] Penn State owned device
[ ] A personal device
[ ] Other – Please specify source: [Type protocol text here if box is checked]
[Type protocol text here]
[Type protocol text here]
[Type protocol text here]
The use of online survey tools and email to collect or send research data containing identifiers that represent more than minimal risk to subjects may have to be approved by Penn State IT - Information Security.
[ ] No – skip to 22.9
[ ] Yes - answer the following questions:
[ ] Penn State REDCap
[ ] Penn State Qualtrics
[ ] Penn State Microsoft Forms
[ ] Penn State Google Forms
[ ] Other - Please specify: - Application: - URL (If applicable):
Depending on the nature of the subject matter involved, certain security requirements must be in place for the audio and/or video recording or photographing of subjects. If the subject matter presents more than minimal risk to the subjects, then, before completing the section below, please contact Penn State IT - Information Security at security@psu.edu to confirm whether these requirements are required.
[ ] No - skip to section 22.10
[ ] Yes - answer the following questions:
[ ] Audio – Describe the intended content of the audio recording:
[Type protocol text here]
[ ] Video – Describe the intended content of the video recording:
[Type protocol text here]
[ ] Photographs of the subjects – Describe the intended content of the photographs:
[Type protocol text here]
[ ] 3-D Images – Describe the intended content of the of 3-D images:
[Type protocol text here]
[ ] Other - Specify:
[Type protocol text here]
[Type protocol text here]
[Type protocol text here]
[Type protocol text here]
[ ] Not applicable
[ ] No
[ ] Yes – indicate who will be doing the transcribing?
[Type protocol text here]
[ ] No
[ ] Yes - specify purpose(s) (e.g., publication, presentations, educational training, future undetermined research):
[Type protocol text here]
[ ] Yes - check one of the following: - [ ] The research involves human subjects as defined by the DHHS regulations (See Worksheet HRP-310). - [ ] The research involves collecting or using biospecimens that are identifiable to an individual. - [ ] If collecting or using biospecimens as part of the research, there is a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual. - [ ] The research involves the generation of individual level, human genomic data.
Note: If [any] of the 4 items above are checked, a COC is automatically issued by NIH and applies to the research. Information about the COC must be included in the consent form.
[ ] No - answer the following question. - [ ] If the research is not funded by NIH, will the investigator apply for a COC for this research study? - [ ] Yes - [x] No
Note: For research not funded by NIH, the IRB may require a COC if the research is collecting personally identifiable information and the information is sensitive and/or the research is collecting information that if disclosed could significantly harm or damage the subject.
[ ] Identification and recruitment of potential subjects follows procedures consistent with privacy standards
[ ] Consent discussion and research interventions will take place in a private setting
[ ] Limiting the information being collected to only the minimum amount of data necessary to accomplish the research purposes
[ ] Limiting the people with access to the identifiable research data to the minimum necessary as specified in the application and consent process
[ ] Other – Specify:
[Type protocol text here]
[ ] Double data entry to reduce risk of errors
[ ] Electronic edit checks to ensure data being entered are not obviously incorrect
[ ] Random internal quality and assurance checking of research data
[ ] Direct entry by subjects
[ ] Other - Specify:
[Type protocol text here]
[ ] No
[ ] Yes – describe the plan for de-identifying the dataset before sharing it with NIH-designated data repositories.
[Type protocol text here]
Note: Data sharing with an NIH-designated data repository may require execution of an institutional certificate. Please review the ‘Institutional Certification for NIH Genomic Data Sharing’ section of the Investigator’s Manual for information about seeking institutional certification.
[ ] No - skip the remainder of section 22.14
[ ] Yes - answer the following questions:
Check all that apply:
What is the name of the third party(ies) (the institution, sponsor, etc.) sending or providing the data?
[Type protocol text here]
Is the third party requiring us to sign a contract regarding the data?
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) receiving or accessing the data?
[Type protocol text here]
Note: Data transfers or disclosures may require a Data Use Agreement (DUA).
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) sending the specimens?
[Type protocol text here]
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) receiving the specimens?
[Type protocol text here]
Note: All material transfers, either sending or receiving, require a Material Transfer Agreement (MTA). Please contact the Office of Technology Management for more information.
[Type protocol text here]
[ ] Data are being received in aggregate/metrics (just counts, no individual data)
[ ] De-identified individual data are being received and there is no linking list at either institution (no identifiers, or links to identifiers, such as code numbers)
[ ] Coded research data without any identifiers are being received and the linking list remains with the entity sending the data; the recipient of the data will not have access to the linking list
[ ] Coded research data with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7 aside from Study Code) are being received and the linking list remains with the entity sending the data; the recipient of the data will not have access to the linking list
[ ] Data with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7) are being received and the linking list remains with the entity sending the data; the recipient of the data will have access to the linking list
[ ] Data with identifiers along with the linking list are being received
[ ] Other – Specify:
[Type protocol text here if box is checked]
[ ] Data are being sent in aggregate/metrics (just counts, no individual data)
[ ] De-identified individual data are being sent and there is no linking list at either institution (no identifiers, or links to identifiers, such as code numbers)
[ ] Coded research data without any identifiers are being sent and the linking list remains with the entity sending the data; the recipient of the data will not have access to the linking list
[ ] Coded research data with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7 aside from Study Code) are being sent and the linking list remains with the entity sending the data; the recipient of the data will not have access to the linking list
[ ] Data with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7) are being sent and the linking list remains with the entity sending the data; the recipient of the data will have access to the linking list
[ ] Data with identifiers along with the linking list are being sent
[ ] Other – Specify:
[Type protocol text here if box is checked]
[ ] De-identified specimens are being received and there is no linking list at either institution (no identifiers, or links to identifiers, such as code numbers)
[ ] Coded specimens without any identifiers are being received and the linking list remains with the entity sending the specimens; the recipient of the specimens will not have access to the linking list
[ ] Coded specimens with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7 aside from Study Code) are being received and the linking list remains with the entity sending the specimens; the recipient of the specimens will not have access to the linking list
[ ] Coded specimens with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7) are being received and the linking list remains with the entity sending the specimens; the recipient of the specimens will have access to the linking list
[ ] Coded specimens with identifiers along with the linking list are being received
Other – Specify:
[Type protocol text here if box is checked]
[ ] De-identified specimens are being sent and there is no linking list at either institution (no identifiers, or links to identifiers, such as code numbers)
[ ] Coded specimens without any identifiers are being sent and the linking list remains with the entity sending the specimens; the recipient of the specimens will not have access to the linking list
[ ] Coded specimens with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7 aside from Study Code) are being sent and the linking list remains with the entity sending the specimens; the recipient of the specimens will not have access to the linking list
[ ] Coded specimens with identifiers (such as dates and/or any of the identifiers listed in section 22.14.7) are being sent and the linking list remains with the entity sending the specimens; the recipient of the specimens will have access to the linking list
[ ] Coded specimens with identifiers along with the linking list are being sent
[ ] Other – Specify:
[Type protocol text here if box is checked]
| [ ] Names | [ ] Medical record numbers |
| [ ] Initials | [ ] Health plan beneficiary numbers |
| [ ] Street address | [ ] Account numbers |
| [ ] City | [ ] Certificate/license numbers |
| [ ] Driver’s License numbers | [ ] Passport numbers |
| [ ] State | [ ] State ID numbers |
| [ ] Zip Codes | [ ] Vehicle identifiers and serialnumbers, including license plate numbers |
| [ ] County | [ ] Device identifiers and serial numbers |
| [ ] Geocodes | [ ] Web Universal Resource Locators (URLs) |
| [ ] Precincts | [ ] Internet Protocol (IP) address numbers |
| [ ] All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death | [ ] Biometric identifiers, including finger and voice prints |
| [ ] Ages > 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older | [ ] Full face photographic images and any comparable images |
| [ ] Telephone numbers | [ ] Any other unique identifying number, characteristic, or code (such as the pathology number) Specify: [Type protocol text here if box is checked] |
| [ ] Fax numbers | [ ] Study code numbers |
| [ ] Electronic mail addresses | [ ] Master list linking study code numbers to subject(s) |
| [ ] Social security numbers | [ ] Genomic sequence data |
| [ ] Other – specify:[Type protocol text here if box is checked] |
This template satisfies AAHRPP elements 1.7.B, I.8.B, I-9, II.2. A, II.2.I, II.3.A, II.3.B, II.3.C-II.3.C.1, II.3.D-F, II.4.A, III.1.C-F, II.2.D↩︎
Unless informed consent is waived by the IRB, screening before consent is only permitted when screening activities are limited to the collection of information through oral or written communication OR when identifiable private information or identifiable biospecimens is obtained by accessing records or stored identifiable biospecimens. Screening before consent is not permitted if data will be used for activities other than eligibility screening/recruitment (e.g., data analysis). In some studies, these procedures may not take place unless HIPAA Authorization is obtained OR a waiver of HIPAA Authorization when applicable for the screening procedures is approved by the IRB.↩︎