Research.sdsu.edu



NOTES TO INVESTIGATORS AND STUDY TEAMS

Of Note: Use this format in all non-exempt research. Red text are instructions, please delete all instructions written in red once the informed consent is complete. Use the section headings within this template and at least an 11 -12 point font.

FOR SMART IRB Relying Sites: The following sections may be revised and customized: The study team contact information, the “What If I am Hurt Section or Injured…” section. The name of your institution may also be changed in the header. Note that the IRB approval stamp is placed in the upper right-hand corner. Keep this area free for the application of the approval stamp. Specific Risks Language not included in this template may be found on the SDSU IRB SMART IRB webpage.

DELETE THIS “Note to Investigator” BOX BEFORE SUBMITTING THE INFORMED CONSENT FORM via InfoEd.

This consent form template contains sample language. The SDSU IRB recommends this sample language with the understanding that the investigator or designated study team member will edit the language to fit their studies. Write the consent form at a sixth to eighth grade reading level. Avoid the use of jargon and the use of undefined acronyms. Please make the consent form as simple, clear, and short as you can while including all required elements found at 45 CFR 46.116.

Informed consent is a process, it is not merely having a potential participant read and sign a document. The informed consent document must be organized and presented in a way that does not merely provide lists of isolated facts. It must provide enough research-related information in sufficient detail to allow the prospective participant, a parent or guardian of a prospective participant, or the legally authorized representative of a prospective participant the understanding of the reasons one might or might not want to participate.

All consent documents must address the OHRP general requirements for informed consent described at 45 CFR 46.116 at:

Consent documents for FDA-regulated studies must also address the elements of informed consent found at 21 CFR 50.25 at:

 (Insert study title—if you are using multiple consent forms for the same study, include the study group in the title. For example for a study involving a separate consent form for parents and teachers you would title the consent forms —Study XYZ –Teacher participants and Study XYZ—Parent Participants)

If this consent form might be signed by a legally authorized representative (LAR), parent, or guardian on behalf of the study participant, add the following statement. Otherwise, delete.

If you are serving as a legally authorized representative, a guardian, or are providing parental permission for a child in this study, the terms “participant”, “you”, and “your” refer to the person for whom you are providing consent or parental permission.

Important things to know about this study

The consent document must begin with a concise and focused presentation of key information that is most likely to assist a prospective participant, parent, guardian or other legally authorized representative in understanding the reasons why one might or might not want to participate in the research. The following is an example of key information. Edit this information based on the study.

If applicable: This study is funded by [add name of funding agency].

We are asking you to join a research study. The purpose of the research is to [state purpose as briefly as possible].

Being in the study involves [number of Visits] over [give duration]. This is what will happen during the study [state the procedures the participant will be involved in as succinctly as possible].

Use as applicable: We do not know if the [treatment/exercise/or other study procedures][would help, prevent or treat][condition, disease or disorder] and it could make it worse.

You do not have to join this study. If applicable: You can choose standard methods to treat your condition or disorder instead of participating in this study. Include These are the reasons you might want to join this study [state reason(s)]. These are the reasons you might not want to join this study [state reason(s)]. If the study involves deception (including incomplete disclosure, a type of minor deception), include the following statement: You might not want to participate in this research study because you are not being told [if applicable everything] about the true purpose of the study.

We will give you information about the purposes, procedures, risks and possible benefits related to this study. We will explain other choices you have. We will also give you more information that you need to make an informed decision about joining this study.

The following information is a more detailed description of the study. Please read this description carefully. We want you to ask us any questions that will help you decide whether you want to join this study. If you join the study, we will give you a signed copy of this form to keep to remind you of what being in the study involves.

If the study is conducted by a student, the Co-Investigator/Faculty Sponsor must be listed.

WHO SHOULD I CONTACT IF I HAVE QUESTIONS or Concerns?

Principal Investigator:

SDSU Department:

Address:

Phone:

Email:

Co-Investigator/Faculty Sponsor:

SDSU Department:

Phone:

Email:

Co-Investigator:

SDSU Department

Phone:

Email:

We are inviting you to join a research study.

We are asking you because [insert reason].

Use as applicable Up to [insert number] of participants will be included at San Diego State University.

Use as applicable Research is not the same as treatment, or other medical or psychological care or therapy. The purpose of research is to answer scientific questions.

Why are we doing this study?

We are doing this study to find out [insert description]. We want to know [insert description].

If your study involves randomization, include a statement of the study treatments and the probability of random assignment to each treatment. Insert the following:

In the study we want to compare [insert experimental condition] to [insert control condition]. [Insert description of how participants will be assigned to each condition and the probability].

What is the time commitment if I join this Research study?

Give the total amount of time a participant will be involved in the study. Include the number of study visits and the frequency of the visits if applicable. See italicized red text below for examples.

Example: Your participation will last one month. You will come to SDSU for eight (8) study visits twice per week for four (4) weeks. Each visit will last one hour.

Example: Your participation will last one hour. You will come to SDSU for one study visit lasting one hour.

When appropriate explain the anticipated circumstances under which the subject’s participation might be terminated by the investigator without regard to the subject’s consent.

The research scientist could stop your participation in the research study at any time even if you want to still be in the study. This would happen if:

• They think it is in your best interest to stop being in the study.

• You are not willing or able to do all the things needed in the study.

• The whole study stops.

If you stop being in the study, your information collected before you stopped being in the study [will/will not] be included in the study. The reason the data might be retained regardless of a subject’s continued participation would be that the data has been combined with information from other participants and the investigator cannot determine which information the specific participant provided. Otherwise, participants have the right to request that their data removed from the data set and must be provided information on how to do this in writing.

What will I be Asked to do in this research study?

If a screening procedure is used to determine eligibility to participate and consent for screening will be obtained include a description of the screening instrument.

For example: To determine if you can join the study, we will ask you some questions. If your answers indicate you can participate, we will ask you to participate in the training and testing portion of this study. If you are not eligible to participate, your information will be destroyed to keep your information private.

Describe the location and the procedures in chronological order. List all procedures the participant is expected to complete for research purposes only. If there are several procedures involved it can be helpful to include a bulleted list or a table as shown below.

It the study involves multiple visits, using a table may be helpful in informing participants about what they will be asked to do as part of the research:

| |Visit 1 |Visit 2 |Visit 3 |Visit 4 |Visit 5 |

| |Day 1 |Day 14 |Month 3 |Month 6 |Month 12 |

|Screening tests and medical |X | | | | |

|history | | | | | |

|Blood draw |X |X |X |X |X |

|(1 Tablespoon.) | | | | | |

|Quality of Life Questionnaire|X | | |X |X |

|Total time |4 hours |30 minutes |30 minutes |3 hours |3 hours |

WHAT ARE THE RISKS OR DISCOMFORTS INVOLVED IN THE RESEARCH?

Simply state what the risks are. DO NOT state that there are no risks associated with your study, or that the risk level is minimal or greater than minimal risk. Describe any risks posed by the research project. You must provide a description of any risks or discomforts the participant might encounter as a result of participation. Include a description of the provisions you have made to address the risks or discomforts.

For Focus Group There is a risk that someone who was part of the focus group could share your personal information outside of the group.

For Survey/Interview: Because we ask personal questions about you, you might remember unpleasant things when we ask you questions. You can refuse to answer any questions that you don't want to answer. You also can decide you want to stop participating.

Even though we will keep information collected in surveys/interviews private, there is a possible risk of loss of privacy.

See Supplement Language on the IRB SharePoint site your research involves the following:

Blood draw

For MRI

For DNA Research

For women participants if applicable add the following: If you are pregnant or become pregnant, the treatment or procedure may involve risks to the embryo or fetus that are currently unknown.

We may discover new information during this research study. This new information my affect whether or not you want to still be in the study. We will tell you so that you can decide if you still want to be in the research.

ARE THERE ANY BENEFITS TO PARTICIPATION?

Note: Incentives paid to the study participant are not benefits of participation.

If there are possible benefits for the participants, include a statement to describe any potential benefits that may result from this research. In addition, add the following statement: However, we cannot be certain that you will receive any benefits by being in this study.

If there are no benefits for the participants use the following language: You may not benefit from participating in this study. However, by joining this research study, you are helping to provide information which may help science and society.

ARE THERE ANY ALTERNATIVES TO Joining this research study?

In some cases standard of care (e.g. medical, psychotherapy, or physical therapy) may be an alternative to participation in the research. When applicable inform participants of appropriate alternative procedures or treatment that might be available. If no alternative make the statement the alternative is to not participate in the research.

WILL MY INFORMATION BE PRIVATE?

Please inform the subjects about the extent to which the study team will hold their private information in confidence. Include the following statement, if there is a possibility that in the conduct of the research the study team may suspect child/elder abuse or neglect. We will keep your information private. However, there are things that the law does not allow us to keep private. If we think that a child or older person is being harmed, we are required to report any suspected harm to authorities.

Include a description of where the research files will be stored, the duration of storage and security measures used to protect the data, including the security of online platforms used to collect and/or store data. For example: Research records will be stored in a locked office in a locked file cabinet and will only be accessible to research staff listed on the first page of this consent form. For cloud-based e-data storage, include a discussion regarding data security standards to allow the IRB to make the required determination at 45 CFR 46.111(a)(7). Research data will be destroyed [at least three] years after the end of this study. If identifiers and the link to re-identify the data will be removed/destroyed prior to three years, give an approximate timeframe for when this will happen.

If the information to be collected will be stored on any electronic device, the investigator should not only have their devices encrypted, but also inform the subject of this process.

If the research is funded by the National Institutes of Health (NIH) and has a Certificate of Confidentiality consider including the following language:

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed.  This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.

 

There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others.  The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.

 

Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research.  The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.

For research involving the collection of identifiable private information or identifiable bio-specimens include one of the following statements: The researcher may remove information that can identify you from the [information (and/or bio-specimen] that you provide in this research. This [information and/or bio-specimen] could be used for future research studies or given to another researcher for another study. In this case, you will not be asked to consent to the future research.

OR

Your [private information and/or bio-specimen(s)] collected as part of this research study will not be used or distributed for future research studies.

Note: If identifiable information or bio-specimens will be stored for future research or will be shared with another investigator, subjects must also prospectively sign a Broad Consent form. This form maybe found on the IRB SharePoint site.

If bio-specimens are used, include the following statement

Bio-specimens, even if they cannot be linked to your identity, may be used for commercial profit. Include a statement indicating whether the participant will share in any profits.

If bio-specimens are used, include the following statement, if applicable (and known)

Whole genome sequencing of bio-specimens will be conducted.

In addition, if your study involves DNA Research, see Supplement Language on the SDSU IRB SharePoint site.

If the information will be shared via email, discuss the methods to keep the transmission of the email private (e.g. encryption).

If an incentive to be paid to research participants will be $600.00 or more (either as one-time payment, or in aggregate), include the following language: To comply with U.S. federal tax law, your name, address, social security number and the total paid to you for participation will be provided to San Diego State University as they are required to report any payments to individuals of $600.00 or more paid during the year, either as a one-time payment or in aggregate, to the IRS. You and the IRS will receive a copy of the IRS 1099 Misc form.

If video or audio tapes are used to record information, describe how you will use the recording, who will have access, how long the recording will be stored and when it will be destroyed, (give an approximate time frame). Also state whether the participant will be able to review and edit the recording(s) prior to any publication. If the recordings will be used for another purpose outside of the research (e.g. teaching purposes), an Audio Visual Release form must be obtained.

We will use the information we learn to for published articles or for presentations to other scientists. We will keep your information private. Others will not be able to identify you in those papers or presentations.

(Include this section if your study involves greater than minimal risk):  WHAT WILL HAPPEN IF I AM HURT OR INJURED While I am in the Study?

Sample Statement -If injury is not covered by the study

If any injury arises as a direct result of participation in this study, we will assist you in obtaining appropriate attention. If you need treatment or hospitalization because of being in this study, you are responsible for payment of the cost for that care. If you have insurance, you may bill your insurance company. You will have to pay any costs not covered by your insurance. San Diego State University will not pay for any care, lost wages, or provide other financial compensation [include San Diego State University Foundation if this research is funded]. However, if you feel you have a claim that you wish to file against the State [or the Foundation], please contact Graduate and Research Affairs - Division of Research Administration at (619) 594-6622 to obtain the appropriate claim forms.

Sample Statement - If Injury is covered by the study

If you need any treatment or hospitalization because of being in this study, all reasonable and customary medical expenses, above what your insurance will cover, will be paid by ________________, as long as: you have followed all of the directions of the investigator, you have notified the investigator immediately of the injury, you have followed medical advice regarding the injury, and you have not deliberately caused the injury.

DO I HAVE TO Join this study?

No, you do not have to join this research study. Even if you agree to join, you can decide later that you do not want to be in the research. If you choose not to join or later decide that you do not want to be in the study, there is no penalty or loss of benefits to which you are otherwise entitled

Only include if study is under FDA oversight: Under FDA regulations, information collected about research participants up to the time of withdrawal from the clinical investigation must remain in the study database. See 21 CFR 312.62(b) and 812.140(a)(3).  If a subject withdraws from a study, removal of data that were already collected may undermine the scientific, and therefore the ethical, integrity of the research.” If an investigator conducting research under the provisions of FDA regulations, the investigator is required to inform subjects that their data cannot be destroyed.

WILL I BE TOLD ABOUT THE RESEARCH RESULTS?

Inform subjects whether or not they will be contacted with the results of the original study after it is completed. Suggested wording follows:

We will contact you with results of this study after the study is completed. .

OR

We will not contact you with results of this study after this study is completed.

For genetic research Supplement Language on the IRB SharePoint site.

WILL IT COST ME ANYTHING to be in the Research?

If there are costs associated with participation (e.g., tests, office visits, parking, etc.) specify, in detail, the extent of these costs. With regard to parking costs at SDSU see the information at: , and provide the approximate total dollar amount for participation.

WILL I BE PAID if I join the RESEARCH?

ADD: the amount and schedule of all payments to the subject. If the PI is giving an incentive for participation, describe the incentive and what is required of the subject to obtain the incentive. If the incentive is a payment, state the amount, formula for proration should the subject or investigator choose to discontinue participation, and when payment will occur. NOTE: In the event participants will be paid $600 or more within the same year as a one-time payment, or in aggregate, the amount paid to the participant must be reported by San Diego State via IRS form 1099 Misc (see the “Will My Information be Private?” section of this consent form template).

If the payment will be determined by drawing or lottery see the SDSU Human Research Protection Program Standards and Practices for more information:

If the PI is not giving an incentive for participation: You will not be paid to participate in this study.

If bio-specimens are used include the following statement

Bio-specimens might be used for commercial profit. State whether participant will share in those profits.

WHOM do I contact if I have questions or concerns?

If you have questions now, please ask. If you have questions later about the research, you may contact... [Investigator name, work phone with area code and international calling code (if applicable]- If you have any questions about your rights as a research participant, or in the event of a research related injury, you may contact the Human Research Protection Program at San Diego State University (telephone: 619-594-6622; email: irb@sdsu.edu). At any time during the research, you can contact the IRB for questions about research rights, to discuss problems, concerns, give suggestions, or to offer input.

Read the following CONSENT TO Participate sections carefully and retain the ONE section applicable to your research.

Consent to Participate:

The San Diego State University Institutional Review Board has approved this consent form, as signified by the Board's stamp.

Your signature below indicates that the study team has explained the study to you and you have read the information in this form. You have had a chance to ask any questions you have about the research. By signing this form, you are agreeing to join the study. You have been told that you can change your mind and stop being in the research at any time. The researcher or a member of his/her research team has provided you with a copy of this consent form. This form includes contact information about who to contact if you have questions. If this study involves a medical experiment, where the participant or their Legally Authorized Representative provides consent include the following language: You have also been given a copy of "The Research Participant's Bill of Rights."

Use this signature block if documented (noted as comprehensive of on the HRPP Initial Application) will be obtained. (Do not leave the first signature section when the second signature section applies).

Use the Signature block below this one if you are requesting a Waiver of Documentation of informed consent from the IRB. (Do not leave the second signature section when the first signature section applies).

Name of Participant (please print) Date

 

Signature of Participant (or their mark if illiterate, if their mark, the witness must indicate participant name) Date

(If applicable; if not delete) Signature of Parent or other legally authorized representative Date

Signature of Investigator  Date

________________________________________________________________________________________

(see note below) Witness Signature, as applicable; if not delete  (see note below) Date

Witness signature: The Witness signature is obtained if an oral presentation of the consent is provided (e.g. the participant or their legally authorized representative is illiterate, or the consent is presented orally in a different language from which the consent is written. The witness must not be a member of the study team and must be present during the entire consent process. In cases whether the consent process is conducted orally in another language, the witness must be fluent in both languages (e.g. the language in which the consent is written and the language the consent is presented orally). In either case, a short form consent form is provided to the participant or their LAR see 45 CFR 46.117(b)(2). In cases where the participant speaks a different language from the language in which the comprehensive, orally presented consent is written, the short form consent must be translated into the language spoken by the participant (or their LAR).

As noted above, If you are requesting a waiver of documentation of informed consent because you believe your study meets the criteria for a waiver of documentation of informed consent at 45 CFR 46.117(c)(i) or (iii) use the following

CONSENT TO PARTICIPATE:

The San Diego State University Institutional Review Board has approved this consent form as signified by the Board's stamp.

The choice to sign this consent document is yours. You do not have to sign this form because (choose one): the only document showing that you participated in this study is your signature on this form, or the IRB determined that the risk of your participation in this research is no more than you would face in everyday life and you are not asked to do anything in this study that would normally require a signed consent form outside of a research study.

However, you may sign this form. The choice is yours. If you choose to sign, the researchers will keep your participation confidential. If you do sign this form, your signature below indicates that you have read the information in this document and the study team has explained the study to you. You have had a chance to ask any questions that you have about the study. Your signature also indicates that you agree to join the study. The study team has told you that you can change your mind and choose to stop participating in this study at any time.

The investigator or a member of his/her research team has provided you with a copy of this consent form with information about whom to contact in the event you have questions.

Signature of Participant (signing is optional and not required) Date

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