MARYWOOD UNIVERSITY
Institutional Review Board
Immaculata Hall, Rm 104, 2300 Adams Avenue, Scranton, PA 18509(570) 348-6211,
Parental PermissionForm Template and Guide
INSTRUCTIONS
USE OFTHIS template IS MANDATORY, AS itcontains regulatory elements.
Before submitting your Completed Form:
- Remove the first 2 ½ pages of instructions (dotted line and all language above it, including the header).
- Remove allred, italicized instructions within the actual template.
- Run a spellcheck and proofread, making sure that there are no errors. Check formattingtoo to make sure it is consistent (font type and size, spacing, etc.).
- Check readability. The IRB requires a score between the 8th and 10th grades for the average participant, but this may need to be decreased depending on the population under study.For readability help, review our Consent Form Readability Tips.
- Not all research situations can be covered by a single template. Please review the “ARE YOU INVOLVING” sections belowfor important information or language that must be added to your form,based on the particular methods you are employing in your study.
- After your submission is reviewed, you may be asked to make changes to your consent form. Before changing it, you must enable the track changes feature. Please see the Track Changes Instructions for this purpose (ignore information about protection/lock, as this form is no longer locked).
Are you involving the following?If so, additional information may be required in your form.
Audio or Video Recording
Under the Confidentiality section, explain who will have access to the recordings and when they will be erased.Also, state who will transcribe recordings (i.e., investigator or other person). While overall study records must be kept for a defined period, recordings may be destroyed once transcribed.
Deception
Deception happens when the investigator supplies incomplete or false information in order to obtain unbiased results in social or behavioral research. When deception is present, the researcher must submit a Waiver or Alteration of Informed Consent Request form (to alter Parental Permission if full disclosure is withheld) and a Debriefing form. See our Deception policy on the IRB’s Policies & Procedures webpage for complete requirements.
External Funding or Collaboration with an Outside Agency or Institution
In the Introduction, state the funding sponsor or collaborator’s name. Under Confidentiality, state if data will be shared with the funding sponsor or collaborating agency, and to what extent this will be done (i.e. de-identified or aggregate data, etc.).
FDA-Covered Products (Drugs, Biological Products or Devices)
According to FDA regulations under 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents for applicable clinical trials. Please add it above the statement of consent (last section).
“A description of this clinical trial will be available on , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
Future Use of Biological Specimens
If you plan to use biological specimens for future studies, state this in the Confidentiality section, explain the timeframe for retention, and provide detail about with whom it will be shared and what the use will be. Include any information required by a funding sponsor, if applicable. Explain if future use of materials is limited to research only taking place at Marywood University. Please be aware that Marywood University owns samples collected. Any planned transfers must be arranged according to Materials Transfer policies.
Future Use of Non-Biological Data
If you plan to use non-biological data for future studies, state this in the Confidentiality section, explain the timeframe for retention, and provide detail about with whom it will be shared and what the use will be. Include any information required by a funding sponsor, if applicable. Explain if future data use is limited to research only taking place at Marywood University. Please be aware of Marywood University’s Intellectual Property policies.
Internet Transmission of Data
Under Confidentiality, add the statement, “While it is understood that no computer transmission can be perfectly secure, reasonable efforts will be made to protect the confidentiality of your child’s transmission of the survey information.” If using a survey site (e.g. Survey Monkey), to the bottom of the assent form/letter page, add “By clicking the button below <accept or approve button> and proceeding with the survey, I wish toparticipate in this study.”
Language Other than English
Once the English version of this form had been reviewed by the IRB, and any requested modifications have been made and approved, the translated version and a Translation Certification form must be submitted. The certification form verifies that at independent translator has reviewed the document and deems it to be an appropriate translation of the approved English version. While the investigator may translate his/her form, he/she may not sign the certification form. Please see our Non-English Speaking policy on our Policies & Procedures web page.
Physically Invasive or Exercise Procedures
If research includes a physically invasive procedure, or an exercise component where there is even a slight risk of injury, the following statement must be included in the Risks section: “In the event that this research activity results in an injury, treatment will be available. This includes first aid, emergency treatment and follow-up care as needed. Payment for any such treatment must be provided by you or your third party payer, if any (such as health insurance, Medicare, etc.). You should ask your insurer about its willingness to pay these costs. You do not give up your legal rights by signing this form.”
Please be aware that some third-party payers do not cover injuries sustained as part of research.
Prisoners
Under voluntary Nature, include “Your decision for your child to participate or to not participate willnot affect probation or parole.”
No Signature on Consent or Parental Consent Forms
Research qualifying for expedited or full review requires documentation of informed parental permission, which means that a signature of a parent (or parents) needs to be collected on theparental permission form. However, where documentation cannot be collected (e.g. Internet or telephone research), if the research involves no greater than minimal risk and no procedures for which written permission is normally required outside of the research context, a waiver of documentation of consent may be requested on the appropriate form.
A waiver may also be requested ifthe only record linking the participant and the research would be the parental permission document, and the principal risk would be potential harm resulting from a breach of confidentiality. A parent(s) needs to be asked whether s/he wants documentation linking his/her child with the research, and the wishes of the parent(s) will govern.
In both instances, waiving the requirement for a signed form does not eliminate the requirement for verbal communication anda written information sheet/parent permissionletter (following the permission template). In this situation, the form is exactly the same, only the signature lines must be removed.
Small Children or Children with Developmental Delays
Under voluntary nature, the researcher should state if he/she will look for any non-verbal cues indicating that a child does not wish to participate or wishes to stop participating. If the researcher will automatically stop participation based
REMOVE ALL OF THE INSTRUCTIONSAT THE DOTTED LINE AND ABOVE
BEFORE SUBMITTING, AS THEY ARE FOR THE INVESTIGATOR ONLY.
REMOVEALL RED, ITALICIZED INSTRUCTIONS WITHIN THE BELOW FORM.
ALLOW ENOUGH SPACE FOR THE IRB STAMP ON EACH PAGE.
DO NOT DELETE THE PAGE NUMBERS.
------
ParentalPermission Form
Title
[Insert study’s title. Make sure it is identical to the title entered into IRBNet.]
Your child is invited to be in a research study about [Insert a general statement about the study.].He/she was selected because[Insert how or why the child was identified, offering specific detail, such as, “because he/she is in the 5th grade at Dunmore Elementary School.”Do not say, “because he/she meets study criteria.”].Please read this form. Ask any questions you may have before agreeing for your child to take part in this study.
This study is being conducted by[Insert researcher(s) name(s). If from Marywood University, indicate affiliation (e.g., “…a graduate student at Marywood University” or “…a faculty member at Marywood University”).This study is being funded by. [Remove the sentence if there isn’t a funder. If there is a funder, name it.]
Background Information
The purpose of this study is to[Insert a short purpose statement in clear and concise language. This is usually just a sentence or two.].
Procedures
If you agree for your child to be in this study, your child will[Insert a clear and simple explanation of all procedures. Include the (1) location of procedures (2) total time commitment of the participant (3) frequency, if more than once, and (4) assignment to groups, if applicable. Mention each procedure if there will be more than one. For instance, if you are accessing medical or school records, state so. You may use bullets or a chart if the procedures are complex. Keep in mind that if you have a control group, control members are still participants, and their activities should be explained.]
Risks and Benefits
The risk [or risks, if plural] in this study is [or are if plural].
[State either, “…no greater than the risks experienced in daily life or activities”OR if there are risks, describe them here. Risks may be physical, psychological, social or economic].
The benefit [or benefits, if plural] in this study is [or are, if plural].
[There does not need to be an individual benefit; however, if there is, provide information here.]
[Also, insert benefit(s) to general knowledge in the field of study or about the condition.]
[Incentives to encourage participation or payments for participation may not be considered as benefits for participants to weigh against risks; therefore, they are not to be listed here. Add them to the next section, if applicable.]
[Use the word “may” rather than “will” when describing risks/benefits.]
Payment/Rewards
Your child will [or will not]receive [List any incentives (e.g., exercise testing results) or compensation such cash payment, raffles, gift cards, class credits, etc. Also, list the incentive disbursement schedule, if applicable.] for taking part in this study.
Confidentiality
The records of this study will be kept private. Information used in any written or presented report will not make it possible to identify your child. Only [Insert who will have access to records, such as the investigator(s), student sponsor, transcriptionist, etc.] will have access to the research records. [If data will be shared with an agency or institution, state that here, and indicate if data will be de-identified.]Research records will be kept in a locked file. Records will be kept for a minimum of three years. [Note: If your study involves private health information accessed through a covered entity (HIPAA privacy rule), or is covered by the FDA (i.e., drugs or devices) or a contract, the records retention period required of the PI may be longer. See our Records Retention policy for details]. Then they will be destroyed. [Insert how they will be destroyed (e.g., paper records will be shredded, computer records will be deleted, etc.). If they are being kept indefinitely, state so, and explain if they will be de-identified.]
Taking Part is Voluntary
Your child’s participation is voluntary. Your decision for your child to participate or not participate will not affect your current or future relations with the investigator [or investigators, if plural]. It will not affect your relations with Marywood University or. [If there is another location where you will be recruiting or is affiliated in another way, name it here; otherwise, remove the “or.”] You may withdraw your child at any time without penalty or loss of benefits to which you are entitled. To withdraw, .
[Insert exactly how they can withdraw (e.g., tell the investigator). They should not have to write a formal letter.]
[If records are anonymous to the investigator, meaning that answers cannot be attributed to an individual, state that they may withdraw up to a certain point (i.e., until they submit a survey).]
[State what happens to data if they withdraw and how (i.e., “Your child’s information will then be destroyed by shredding). Keep in mind that you cannot state that their data will be used, as they should be given the choice to have it destroyed or to have it used.]
Contacts and Questions
The investigator conducting this study is. [Insert investigator(s) name(s) only.]
You may ask questions now or later. If you have questions later, you may contact the researcher at. [Insert Principal Investigator’s email address and phone number.][If the researcher is a student, add the sponsor’s name and contact information here.]
If you have questions related to the rights of research participants or research-related injuries (where applicable), please contact Marywood University’s Director of Human Participants Protection and Research Compliance, Courene M. Loftus, MPA, CIP at (570) 961-4782 or .
You will be given a copy of this form to keep for your records.
Statement of Consent
I have read the above information. I have asked questions and have
received answers. I consent for my child to participate in this study.
_________
Child’s Name (Please Print)
_______________
Printed Name ofParent/Legal Guardian(1) Signature of Parent/Legal Guardian(1) Date
______________
Printed Name ofParent/Legal Guardian(2) Signature of Parent/Legal Guardian(2) Date
______
Name of (Authorized) Person Obtaining Permission/Consent Date
Page 1 of 5
Template Revised 12/9/2016