IRB – Review of New Research

Principal Investigator for the project:

Full Title of the Study:

SP Code:

List MC/MCRF Departments/Centers associated with this study:

Additional Investigators:

(MCRF IRB of Record only)

Research Support Staff (include research activities performed by the individual such as identify/recruit study participants, obtain informed consent, intervene or interact with study participants (e.g., administer survey, conduct or oversee physical intervention), obtain individually identifiable private information about study participants, other):

In layperson’s terms please summarize the purpose of this research activity in 3-5 sentences:

Attach a protocol unless this application is solely for the purpose of creating a database or biobank for future research.

Review Requested:

Expedited Review – Complete Appendix - Expedited Review

Convened IRB

3.	Identify the locations at which the study is being conducted:

Marshfield Clinic site(s)

Ministry Health Care site(s) (includes St. Joseph's Hospital, St. Clare's Hospital, and St.

Michael's Hospital)

Sacred Heart Hospital, Eau Claire (oncology only)

Multiple sites, including at least one site external to Marshfield Clinic or Ministry Health

Care answer the following:

List the sites:

Identify which states within the U.S the sites are located:

Is there one or more site outside of the U.S.?

No

Yes

4.	Note applicable resources the study team has in place to ensure participant safety and welfare are protected:

Adequate number of staff

Well-trained staff

Private space for interventions

Equipment necessary to conduct research

Information systems support

Investigational Drug Pharmacy support

Other: Please Explain:

5.	Does this research involve the use of recombinant DNA or toxins/agents at or above biosafety

level 3 at Marshfield Clinic?

No

Yes

If you selected "Yes," include the approval letter from MCRF Institutional BioSafety Committee

6.	Have you applied for or received funding for this project?

No

Yes - identify the sponsor:

7.	Is MCRF the direct recipient (i.e., prime awardee) of a federal grant or cooperative agreement

awarded to conduct this research?

No

Yes - submit a copy of the complete grant, including other support and budget

8.	What potential benefits are reasonably expected from this research? Check all that apply:

None anticipated

personal to participants

to society or others

Other

Describe the above selection(s) in detail:

9.	What potential risks, harms and discomforts are reasonably expected from this research? Check

all that apply:

Drug / biologic / device side effects

Social risks / harms

Psychological risks / discomforts

Economic risks

Risk to privacy/confidentiality

Other physical risks / discomforts

Describe the selection(s) above in detail (drug/biologic/device side effects should be

described in the appropriate appendix):

What steps will be taken to prevent or minimize risks or discomforts?

Discuss how risks to participants are reasonable when compared to the anticipated benefits to

participants:

12. What is the importance of the knowledge that may reasonably be expected to result from this

research?

13. The plan to monitor data and subject safety is to be determined based upon the level of risk

inherent to the project. Choose the category below that best describes your project and provide

the required information:

Minimal Risk - The PI will closely monitor the study and report any unanticipated

problems to the IRB. No further documentation is required at this time.

Greater than Minimal Risk – Answer all of the following questions:

Who will oversee the data and subject safety for this study? Check one:

A small, sponsor affiliated oversight group

An Independent Data Safety Monitoring Committee (DSMC)

b. Expertise/role and affiliation for members of the small oversight group or

DSMC:

c. How frequently will the data be reviewed?

d. What information will be evaluated?

e. Clinical trials also frequently include site visits conducted by a study

monitor. If this study will include monitor visits, how frequently will they

occur?

f. List any stopping rules for this research:

14. Check all of the following activities that apply to this research. Fill out all applicable appendices

and return to question 14:

Interaction with human participants

Complete Appendix - Interaction with Human Participants

Clinical intervention or treatment

Complete Appendix - Clinical Intervention or Treatment

Phase IV clinical trial

Complete Appendix - Clinical Intervention or Treatment

Use of a Drug or Biologic in Humans

Complete Appendix - Use of a Drug or Biologic in Humans

Use of Device in Humans

Complete Appendix - Use of Device in Humans

Placebo, sham procedure or withholding / postponing standard treatment

Complete Appendix – Clinical Intervention or Treatment

Provision of samples from a clinical trial to an existing bio-bank for future research

Complete Appendix – Clinical Intervention or Treatment

Creation of a Research Bio-bank

Complete Appendix – Creation of a Research Bio-bank

Analysis of Records, Data or Images,

Complete Appendix - Analysis of Records, Data or Images

Creation of a Research Database

Complete Appendix – Creation of a Research Database

Human Specimen Research

Complete Appendix- Research with Existing Human Specimens

Deception

Complete Appendix - Clinical Intervention or Treatment

Internet-based Research

Complete Appendix Internet-Based Research

Sharing data and/or biological material with an external party

Complete Appendix – Sharing of Data and/or Biological Material

Interviews, surveys, questionnaires, Focus Groups

Complete Appendix Interviews, Surveys, Questionnaires, Focus Groups

Transnational Research - Complete Appendix Transnational Research

15. Provide the anticipated number of local participants (people or medical records) for whom you are

seeking MCRF IRB approval:

If this is a multi-site study, indicate the number of anticipated participants across all sites:

Not applicable

Specify the age range of the study population who may take part:

Describe how potential participants will be identified:

19. How will the study team gain access to this population?

20. Specify the study target population(s) for which you are seeking IRB approval (check all that

Apply):

Adults

Adults lacking Capacity to Consent

Complete Appendix - Adults Lacking Capacity to Consent

Pregnant women, fetuses and/or neonates

Complete Appendix - Pregnant Women, Fetuses and/or Neonates

Children

Complete Appendix - Children

Employees of or students in training at the PI’s institution

Describe the purposes or reasons for targeting this group for this research:

What steps will you take to ensure employees and/or students do not feel undue pressure to participate due to their status as employees or students?

Other potentially vulnerable targeted populations chosen because of ethnicity, cultural

or social beliefs or practices, or issues of gender, or sexuality

Describe the vulnerable population:

Describe the purposes or reasons for targeting this group for this research:

Identify any steps that will be taken to respect social or cultural differences, and to minimize any risks during the research, specific to this group:

Unknown (non-targeted surveys, secondary use of de-identified specimens or data)

21. Will any participants be excluded based on age, gender, race/ethnicity, pregnancy status,

language, education or financial status?

No

Yes - describe the status to be excluded:

Give the reason for the exclusion and justify:

22. Indicate the consent document(s) and process(es) to be used in this research activity. If there are

participant populations with different consent document(s) and/or processes, check all that apply:

Written informed consent/parental permission

Complete Appendix Written Informed Consent Document

Written assent

Complete Appendix Written Informed Consent Document

Translated written consent form

Complete Appendix Written Informed Consent Document

Translated written assent form

Complete Appendix Informed Consent Document

Written short form

Complete Appendix Written Short Form

Waiver of documentation of informed consent, assent or parental permission

Complete Appendix Waiver of documentation of Informed Consent, Assent

or Parental Permission

Waiver or alteration of informed consent, assent or parental permission

Complete Appendix Waiver or Alteration of Informed Consent, Assent or Parental Permission

23. Does this research collect information about participant diagnoses, potentially including HIV status?

No

Yes

If Yes, as principal investigator, I attest that HIV status identified via Marshfield

Clinic records will only be used as required for this research study. It will not be released to any person not connected with this study, and the final research product will not reveal information that may reveal the identity of the participant unless I obtain consent for this disclosure from the participant.

24. Will Protected Health Information be accessed, used or disclosed for this research activity?

No

Yes - Indicate all authorization forms and/or processes that will be used:

A. Written Authorization form - *** You are required to develop the authorization from

the approved HIPAA Authorization templates found in Forms Library and

obtain signed authorization from each participant

B. Waiver of HIPAA Authorization

Complete Appendix Waiver or Alteration of HIPAA Authorization

C. Alteration of HIPAA Authorization

Complete Appendix Waiver or Alteration of HIPAA Authorization, and

answer the following:

Indicate what you would like to exclude as part of your alteration request (check all that apply):

Description of PHI to be used or disclosed

Name or class of person to use or disclose PHI

Name or class of person to whom you will disclose PHI

Description of each purpose of the use or disclosure of

PHI

Expiration Date

Dated signature of the research participant

Participant has the right to revoke the authorization in

Writing

Either: the covered entity may not condition payment,

treatment, enrollment or eligibility for enrollment on

whether the participant signs the authorization; or the

consequences to the participant of a refusal to sign the

authorization when the covered entity can invoke such

conditions

That PHI disclosed pursuant to the authorization may be

re- disclosed by the recipient and no longer protected by

the Privacy Rule

D. Representation for Reviews Preparatory to Research

Will study staff access PHI for research screening or recruitment prior to obtaining authorization from the research participants?

No

Yes - the PI attests that he or she will:

Request the minimum necessary PHI

Use PHI only to identify potential participants or prepare a research protocol

Ensure that no PHI used for this purpose leaves Marshfield Clinic

Request only PHI that is necessary for screening, recruitment or protocol preparation

Agree

Will PHI used for reviews preparatory to research be disclosed to anyone who is not a physician or staff member of Marshfield Clinic? If you select "Yes," please ensure you have completed the appropriate data or material section(s) under Study Activities.

No

Yes

E. Representation for Research on Decedents

Will study staff access PHI of deceased individuals for research purposes?

No

Yes

Request the minimum necessary PHI

Request only PHI needed for the research

Use the decedent PHI only for research

Agree

If PHI used for reviews preparatory to research or for research on decedents will be disclosed to anyone who is not a physician or staff member of Marshfield Clinic, the PI attests that he / she will ensure that the disclosure is accounted for to satisfy the HIPAA Privacy Rule requirements:

Agree

Complete appropriate Appendices and/or signature and certification page.

SIGNATURE AND CERTIFICATION

Disclosure of significant financial or associational interest

Do you have a significant financial or associational interest to disclose, as described in the institutional policy, “Investigator Conflicts of Interest in Research?”

No - by checking this box, I certify that I have made the required annual disclosures and have

no additional interests to disclose.

Yes - Research Conflict of Interest Committee disclosure review must take place before

making this submission to the IRB. Contact ORIP for assistance with the disclosure process

and access to the disclosure form. Please note that MCRF IRB will not serve as the reviewing

IRB for external engaged individuals who have a potential conflict of interest.

Principal Investigator Attestation

I certify that the information provided herein and attached is true and complete to the best of my knowledge, and that research staff are qualified (e.g., credentials and when relevant, privileges) to perform procedures assigned to them during the study.

Comments:

_______________________________________________

Signature of Principal Investigator	Date

Printed Name of Principal Investigator	Routing Location

Printed Name of Person Completing Report	Routing Location

Printed Name(s) of Study/Regulatory Staff to receive	Routing Location

IRB Correspondence (Limit 2)

Submit completed paperwork to: Office of Research Integrity & Protections – 1R4

Appendix

Expedited Review

Does the research involve more than minimal risk?

No

Yes - does not qualify for expedited review (Return to page 1 and continue with question 4.)

All of the activities must fall under one or more of the category(ies) below. Select all that apply to this research:

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

Research on drugs for which an investigational new drug application (21 CFR 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

Research on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

#1.a. applies

#1.b. applies

2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

from healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week.

from other adults and children (defined as “persons who 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 the research will be conducted.” 45 CFR 46.402(a)), considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Applies

3. Prospective collection of biological specimens for research purposes by non-invasive means.

Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

Applies

4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Applies

5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for nonresearch purposes (such as medical treatment or diagnosis).

NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human participants 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

Applies

6. Collection of data from voice, video, digital or image recordings made for research purposes.

Applies

7. Research made on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human participants 45

CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.

Applies (Return to page 1 and continue with question 4.)

None of the above - does not qualify for Expedited Review – Complete remainder of application

for Convened IRB (Return to page 1 and continue with question 4.)

Appendix

Interaction with Human Participants

Describe the recruitment process:

Submit all recruitment materials to be used

Explain the steps you will take to respect potential participants’ privacy in the recruitment process:

Do the recruitment materials and the recruitment process meet the requirements of the procedure, “Identification, Recruitment and Compensation of Research Participants"?

No

Yes

Other than choosing not to take part, list any specific alternatives that are available and might be as advantageous as the research:

Not applicable

For each area below, estimate the time commitment for participants for activities required solely for purposes of the study:

Visits:

N/A

Number of in-person visits:

Average time per visit:

Record-keeping (e.g. diaries, questionnaires, surveys):

No

Yes

Total estimated time to complete:

Telephone Follow-up:

No

Yes - how often:

Average amount of time per follow-up:

Describe other time commitment(s):

Will participants receive incentives or compensation to take part in this research study?

No

Yes - answer the following:

What is the proposed amount of any incentives/compensation? $

At what study points will compensation/incentive be provided? If at more than one time point, indicate each time point and the corresponding amount:

Are some or all of the participants <18 years of age?

No

Yes - to whom will the incentive / compensation be offered:

Parent or Guardian

Child Participant

Describe what steps you will take to facilitate an orderly withdrawal from the research should a participant decide to stop taking part in the research or be removed from the study at PI’s discretion:

Not applicable

Do you plan to return anticipated research results to participants?

No - please justify:

Yes

If you selected "Yes," what type of results will you be returning?

Aggregate

Individual level

If individual level, describe the process for reporting results to

participants, including who will disclose results and whether any

additional resources are in place, such as genetic counseling:

Please describe your plan for sharing clinically actionable, incidental findings with participants, including who will assess whether the information should be reported to participants and the qualifications of those making such assessments:

Not applicable

Is this study contractually bound to follow ICH GCP E6 Standards?

No

Yes - Include any existing ICH GCP Adverse Event Reports

List any additional documents to be provided to subjects:

Have you been designated via an agreement with the research sponsor, as the Responsible Party for Clinical Trials Registration and Reporting?

No

Yes

Appendix

Clinical Intervention or Treatment

How would most Marshfield Clinic patients who are eligible for this study be treated, or what intervention would take place, if they did not take part in this research?

List all activities (office visits, assessments, labs, imaging, etc.) that are to be performed solely for the research activity, and indicate whether the participant and/ or their insurance company will be responsible for payment:

Will the participant be responsible for costs of interventions and interactions that are standard care components of the research?

No

Yes

Does the study include radiological imaging (CT, PET, MRI, X-Ray)?

No

Yes - answer all of the following:

Are all imaging procedures to be performed considered part of the routine clinical care for this population, disease, or condition?

Yes

No - answer all of the following:

Describe the imaging procedure(s) being performed only for research purposes:

Explain why the additional imaging procedure is necessary:

Will a contrast agent be administered?

No

Yes - answer the following questions:

Identify the contrast agent:

Describe any screening procedures participants will undergo prior to administration of the contrast agent:

Complete the following for Phase IV Clinical Trials only:

Indicate which required IRB submission criterion is met:

The research is required by the FDA

The research is a long term study of the effect of the drug on morbidity and mortality

The research is a clinical trial to supplement pre-marketing data for a drug approved via FDA

Fast Track,

Accelerated approval or Priority Review

The research is a clinical trial of the drug in a new population

The research is a clinical trial of the drug for a new indication

Scientific merit of the study has been confirmed by the MCRF Research Committee

The research is designed to study the long-term incidence of adverse effects

The research is designed to explore a specific adverse effect

The research is designed to gather additional, defined information

Not applicable - If the project does not meet any of the above, the IRB, by policy, will not

consider approval of the project.

Complete the following if study involves placebo, sham procedure or withholding / postponing standard treatment:

Will the study involve the use of placebo?

No

Yes - answer all of the following:

Describe how the placebo will be used:

Justify the use of the placebo:

What is the source of the placebo:

Industry sponsor

Investigational Drug Pharmacy

Other - explain:

Will this study involve the use of a sham procedure?

No

Yes - answer all of the following:

Describe the sham procedure:

Justify the use of the sham procedure:

Will this study involve washing out, withholding or postponing standard treatment?

No

Yes - answer all of the following:

Describe what standard treatment will be washed out, withheld or postponed:

Provide justification for the washout, withholding, or postponing of standard treatment:

Indicate how participants will be monitored for safety during this period:

What, if any, rescue medication will be allowed?

Complete the following if study involves deception:

Describe the deception to be employed:

Provide justification for the use of deception:

Describe the debriefing plan:

Complete the following if study involves collection and storage of bio-specimens in an existing bio-bank for future research:

May participants take part in the main study and decline sample collection?

No

Yes

Where will samples be stored?

What protections will be in place to keep samples secure?

What participant information will be retained with the samples?

Explain how participants may have samples destroyed if they change their minds:

Appendix

Use of a Drug or Biologic in Humans

Choose the applicable category(ies):

FDA Approved Drug or Biologic being used for an approved indication

Brand name of drug or biologic to be used:

Generic Name:

Provide a brief rationale for using this drug or biologic in this research:

Investigational Drug or Biologic or Off-Label Use of an FDA Approved Drug or Biologic

Identify the Drug or Biologic(s):

Trade Drug Name:

Generic Drug Name:

Investigational Drug Name:

Is the drug supplied at no cost?

No

Yes

IND #

Dose Range:

Frequency:

Route of administration:

Possible Untoward Effects and their Symptoms:

Contraindications and Interactions, If Known:

The drug(s) or biologic(s) is/are:

Investigational

FDA-approved drug being used off-label

If you selected "Investigational," submit the Investigational Drug Brochure. If you selected "FDA-approved drug being used off-label," submit the manufacturer’s approved labeling information.

Indicate how the drug(s) or biologic(s) will be managed:

By the Investigational Drug Pharmacy

Provided by Sponsor as needed for each participant - attach a copy of the

sponsor’s drug control plan

Other - describe the plan for storage, control, and disposition of unused supply of

the drug or biologic:

Submit protocol specific documentation (e.g. sponsor’s protocol cover sheet, FDA or sponsor correspondence, etc.) of the IND number.

Does a Marshfield Clinic investigator hold the IND?

No

Yes - I certify that I am aware of and will comply with the regulatory requirements

of a sponsor of an IND as detailed at 21 CFR 312

Appendix

Use of Device in Humans

Choose the applicable category:

1. FDA Approved device being used for an approved indication (Complete this section only)

Device Name:

Manufacturer:

Brief Description of the Device

Device’s Proposed Use:

Rationale for the choice of this device compared to others that could have been used:

OR

2. Investigational Device or off-label use of an FDA approved device

Identify the device(s):

IDE #:

Device Name:

Device Mode:

Device Serial Number:

Manufacturer:

Device Status:

Investigational

Approved, but use in this research is off-label

Brief description of the device:

Describe the device's proposed use:

Indicate how the device will be managed:

Provided by sponsor as needed for each participant. (Submit a copy

of the sponsor’s device control plan)

Other - please describe the plan for storage, control, and disposition

of unused supply of the device:

Choose the applicable category (A or B):

Significant Risk (SR) (e.g. sutures, pacemakers, stents, orthopedic implants)	implants)

Submit protocol specific documentation (e.g. sponsor’s protocol cover sheet, FDA or sponsor correspondence, etc.) of the IDE number. IRB approval cannot occur unless documentation of the IDE has been provided.

Does a Marshfield Clinic investigator hold the IDE?

No

Yes

If you selected "Yes," does the PI certify that he/she is aware of, and will comply with, the regulatory requirements of a sponsor of an IDE as detailed at 21 CFR 812?	No

Yes

Non-Significant Risk (NSR) (e.g. contact lenses, lens solution, Foley

catheters) - The FDA considers an investigation of a Non-Significant Risk

Device to have an approved IDE when the IRB concurs with the NSR

determination and approves the study.

Who will ensure that the abbreviated IDE requirements at 21 CFR 812.2

are met for this study?

Study Sponsor

Principal Investigator

OR

3. IDE Exempt (IRB review is still required)

The device fulfills which one of the following IDE Exemption categories:

A device, other than a transitional device, in commercial

distribution immediately before May 28, 1976, when used or

investigated in accordance with the indications in labeling in

effect at that time.

A device, other than a transitional device, introduced into

commercial distribution on or after May 28, 1976, that FDA has

determined to be substantially equivalent to a device in

commercial distribution immediately before May 28, 1976, and

that is used or investigated in accordance with the indications in

the labeling FDA reviewed under subpart E of part 807 in

determining substantial equivalence.

A diagnostic device, if the sponsor complies with applicable

requirements in 21 CFR 809.10(c) and if the testing:1) Is

noninvasive; 2) Does not require an invasive sampling

procedure that presents significant risk; 3) Does not by design or

intention introduce energy into a participant; and 4) Is not used

as a diagnostic procedure without confirmation of the diagnosis

by another, medically established diagnostic product or procedure.

A device undergoing consumer preference testing, testing of a

modification, or testing of a combination of two or more devices

in commercial distribution, if the testing is not for the purpose of

determining safety or effectiveness and does not put participants at

risk.

A custom device as defined in 21 CFR 812.3(b), unless the device is

being used to determine safety or effectiveness for commercial

distribution.

Appendix

Analysis of Records, Data or Images

Indicate all sources of data, records or images that will be used for this study:

Marshfield Clinic electronic health record

Marshfield Clinic paper record - specify:

Marshfield Clinic database - specify:

Ministry Health Care database – specify:

Other database or source including external sources - specify:

Describe the population whose records/data/images will be accessed for this research activity:

Provide the estimated number of records/data/images that will be accessed for this research activity:

Provide a brief rationale for the number of records/data/images to be used in this research activity:

Which of the following will be retained in research records?

No identifiers

Study code linked to direct identifiers

Random study code with no links

Indirect identifiers (city, state, county, precinct, zip code, dates [except year] directly related to a

subject, ages over 89 and all elements of dates [including year] indicative of such age)	Direct identifiers (name, address, phone#, fax, email, SSN, MHN, health plan #, account #’s,

certificate /license #’s, vehicle ID #’s, device ID #’s and serial #’s, URL, IP address, biometric

ID’s, facial photos or comparable images, any code derived from information about the person)

How will the data be recorded, and where will the data be stored?

What protections are in place internally and externally to protect patient confidentiality? Check all that apply:

Patient records stored in a de-identified way, eliminating linkage to unique identifiers (inter-file

linkage)

PHI elements obfuscated or “fuzzed”

PCs used in data collection equipped with encrypted hard drive

Data entry tools and databases maintained behind firewalls

User-level password-protected data entry

Shared login password-protected data entry

Audited data access to research data warehouse

Paper records locked in a secure location

Certificate of Confidentiality issued by a DHHS agency

Error inoculation (inserting random error into dataset to secure confidentiality while still allowing

useful statistical analysis)

Top coding (replacing values above a certain level with a threshold value)

Use of an Honest Broker (a third party holds the data and identifiers)

Other - identify:

Describe your plan for the disposition of study data upon study completion:

Appendix

Internet-Based Research

Do the internet-based research activities include data mining with no interaction with research participants, such as observation of an online message board or chat room?

No

Yes - answer the following questions:

How will research participants be informed about the research?

Will you obtain permission to conduct the research from the list/group/site/community manager?

Yes

No - explain why not:

Does the computer or internet-based research activity involve interaction with participants (e.g., internet-based surveys, interaction in chat rooms, direct email contact)?

No

Yes - describe:

Submit a copy of the survey or scripts to be used

Describe measures to protect the privacy of participants and confidentiality of information transmitted or collected via the internet:

Could the data collected or transmitted potentially place participants or their families at risk of criminal or civil liability, damage financial standing, employability, insurability, or reputation, be stigmatizing or result in stolen identity?

No

Yes

Describe the risks posed:

Describe your plan for minimizing these risks:

Appendix

Sharing of Data and/or Biological Material

The following will be shared:

Data

Biospecimens

Both

In general terms, describe what is to be shared.

Indicate who will have access and for what purpose.

For each group of data or material to be shared, discuss which of the following best describes the data/material to be shared:

Aggregate data

Coded data/material (code not derived from or related to information about the person)

Code linked to direct identifiers

Random study code with no links

Indirect identifiers included (city, state, county, precinct, zip code, dates [except year] directly related to a subject, ages over 89 and all elements of dates [including year] indicative of such age

Direct identifiers included (name, address, phone#, fax, email, SSN, MHN, health plan #, account

#’s, certificate / license #’s, vehicle ID #’s, device ID #’s and serial #’s, URL, IP address, biometric ID’s, facial photos or comparable images, any code derived from information about the person)

If data/material to be shared will contain direct or indirect identifiers, explain why identifiers are needed, and how the information will be secured both during the transfer of data/material and once at the recipient’s site.

Not Applicable

Explain why coded information is not sufficient.

State whether the receiving organization/recipient will release data with identifiers to others.

If so, for what purpose?

Appendix

Pregnant Women, Fetuses and/or Neonates

The following categories will be included in this research (check all that apply):

Pregnant Women and Fetuses

Neonates (of uncertain viability, and nonviable) - Skip to Question #7, if Neonates only.

Where does the prospect of direct benefit lie? Check all that apply:

Pregnant Women Only - Explain:

Fetus Only - Explain:

Both Pregnant Women and Fetuses - Explain:

If there is no prospect of direct benefit to Pregnant Women or Fetuses, answer the following

questions:

Is the risk to the fetus greater than minimal risk?

No

Yes - answer the following:

Is the purpose of the research to develop important biomedical knowledge which cannot be obtained by any other means?

No - stop and contact ORIP immediately to discuss.

Yes - explain:

Describe preclinical studies (including studies on pregnant animals) and clinical studies (including studies on non-pregnant women), where scientifically appropriate, that provide data for assessing potential risks to pregnant women and fetuses:

Explain what steps are taken in this protocol to reduce risk to the pregnant woman or fetus to the least possible level:

Will any inducements be offered to terminate a pregnancy?

No

Yes - contact ORIP office immediately to discuss.

Will any individual engaged in the research have any part in any decisions as to the timing, method or procedures used to terminate a pregnancy?

No

Yes - Contact ORIP immediately to discuss.

State who (other than the investigator and key personnel) will determine the viability of a neonate and what procedures will be used to determine viability:

Describe preclinical studies and clinical studies, where scientifically appropriate, that provide data for

assessing potential risks to neonates:

The viability of neonates to be involved in the research is (check both if both apply):

Uncertain Viability

Nonviable

Explain the selection made above:

10. If you selected "Uncertain Viability" above, which of the following best describes the risk(s) posed to

the neonate(s) of uncertain viability?

The least possible and the research holds the prospect of enhancing the probability of survival

to the point of viability- explain:

No added risk will result from the research and the purpose of the research is development of

important knowledge that cannot be obtained by other means - explain how this is met:

11. If you selected "Nonviable" above, explain how each of the following conditions for inclusion of

nonviable neonates is met:

There will be no added risk to the neonate resulting from the research:

The purpose of the research is the development of important knowledge that cannot be obtained by other means:

Appendix

Children

Select the category that best describes the research:

Not greater than minimal risk

More than minimal risk is presented by an intervention or procedure that holds the prospect of

direct benefit for the individual child, or by a monitoring procedure that is likely to contribute to

the child's well-being

Explain how the risk is justified by the anticipated benefit to the individual child:

Explain how the relation of the anticipated benefit to the risk is at least as favorable to the child as that which would be presented by available alternative approaches (e.g., other treatments):

More than minimal risk is presented by an intervention or procedure that does not hold the

prospect of direct benefit for the individual child, or by a monitoring procedure that is not likely

to contribute to the child’s well-being

Explain how the risk represents a minor increase over minimal risk:

Explain how the intervention or procedure presents experiences to children that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations:

Explain how the intervention or procedure is likely to yield generalizable knowledge about the child's disorder or condition that is of vital importance for the understanding or amelioration of the child's disorder or condition:

Explain the process you will use to obtain informed assent from children:

N/A - seeking waiver of parental permission / assent

3. Explain the process you will use to obtain permission from parents/guardians:

N/A - seeking waiver of parental permission/assent

4. If participation is to continue beyond the time that the child participant is 18 years of age, describe the

process to be used to re-consent the participant:

N/A - participation will not continue beyond the time the child is 18 years of age.

N/A - participation is to continue beyond the time the child is 18 years of age, but seeking

waiver of informed consent / assent

5. Will you be targeting research participants who are wards of the State or any other agency or
institution?

No

Yes – explain:

Appendix

Written Informed Consent Document

How much time is allotted for the informed consent interaction for this specific study?

Describe how the participants' privacy will be protected during the informed consent process:

After meeting or speaking with study personnel, how long does an individual have to decide whether to join this specific study?

Other than the informed consent document, what information will be given to participants during the consent process?

Submit any other written materials to be given or presented in addition to other study materials requested elsewhere in this application.

What is your process for determining whether participants understand what you have told them during informed consent?

How will you evaluate the ongoing consent of a participant throughout the course of the study if multiple interactions will take place?

How will coercion and undue influence to consent be reduced and controlled in the process?

Submit the consent document(s) planned to be used.

Complete the following if written assent will be obtained.

Written assent is required from children 7 and above for non-therapeutic research, and 12 and above for therapeutic research. Verbal assent may be required for adults lacking capacity to consent.

Select the category(ies) of participants from whom assent will be obtained:

Children

Adults Lacking Capacity to Consent

What steps will you take to tailor your presentation to the prospective participants (minors or adults lacking capacity) who are considering enrollment?

Attach any other materials to be distributed during the assent process.

How much time is allotted for interacting with the prospective participants (minors or adults lacking capacity) for purposes of seeking assent?

What is your process for determining whether the participants providing assent understand what you have told them?

After meeting or speaking with study personnel, how long does the prospective participant (minor or adult lacking capacity) have to decide whether to join this specific study?

How will you evaluate the ongoing assent of a minor participant or an adult participant lacking capacity throughout the course of the study, if multiple interactions will take place?

Submit the assent document(s) planned to be used.

If study involves utilizing translated consent or assent forms, submit the following

documents:

All draft translated consent and/or assent document(s)

A translation or validation certificate from an independent translation service for each

draft consent/assent form submitted.

Not applicable

Appendix

Written Short Form

Select the short form(s) to be used to obtain consent and/or assent:

Spanish short form previously approved by MCRF IRB

Hmong short form previously approved by MCRF IRB

Short form not previously approved by MCRF IRB –

submit draft of proposed short form and a validation certificate from an independent translation service.

How much time is allotted for the interaction to present the short form for this specific study?

What is your process for determining whether participants understand what you have told them during informed consent?

Appendix

Waiver of Documentation of Informed Consent,

Assent or Parental Permission

Indicate the waiver you are requesting and provide the required information (check all that apply):

Waiver of consent documentation

Waiver of assent documentation (children or adults lacking capacity to consent)

Waiver of parental permission documentation

Requirements for one of two options below must be met for a waiver of documentation to be approved by the IRB:

OPTION 1: Both answers must be NO for a waiver of consent documentation to be considered by the

IRB:

1. Does the research present greater than minimal risk?

No - please explain:

Yes

2. Does the research involve procedures for which written consent is normally required outside of

the research context?

No - please explain:

Yes

OPTION 2: Both answers below must be YES for a waiver of consent documentation to be considered by the IRB. This option is not available for FDA-regulated research. Under this option, each participant must be asked whether they would prefer a signed information sheet linking them to the research and the participant's wishes must govern.

1. Would the only record linking the participant and the research be the consent document?

No

Yes

2. Would the principal risk to the participant be potential harm resulting from a breach of

confidentiality?

No

Yes

For either option, select the ways informed consent will take place:

Face-to-face

Mailed information sheet with face-to-face follow up

Mailed information sheet with telephone follow up

Mailed information sheet with Marshfield Clinic Tele-health system follow-up

Other - identify:

How much time is allotted for each informed consent interaction for this study?

After meeting or speaking with study personnel, how long does an individual have to decide whether to join this specific study?

What is your process for determining whether participants understand what you have told them during informed consent?

Other than the informed consent script or information sheet, what other information will be provided to potential participants during the consent process?

Submit any other materials to be distributed during the consent process.

How will you evaluate the ongoing consent of a participant throughout the course of the study if multiple interactions will take place?

Submit a copy of the information sheet or telephone script.

Appendix

Waiver or Alteration of Informed Consent,

Assent or Parental Permission

Indicate the applicable type of waiver(s) being requested and provide the required information below (Check all that apply):

Waiver of consent

Waiver of assent (children)

Waiver of parental permission

Alteration of one or more elements of informed consent - what element(s) are you requesting

to be altered?

Is the research FDA regulated?

No

Yes - If research involves a product regulated by the FDA or if the results of the research may

be submitted to FDA as part of a marketing application, consent cannot be waived.

Is the research subject to the approval of state or local government officials and designed to study public benefit or service programs or procedures for obtaining benefits under those programs, changes in or alternatives to those programs or procedures, or changes in methods or levels of payment for benefits or services under those programs?

No

Yes - explain why the research could not ‘practicably’ be carried out without the waiver or

alteration:

In order to justify the waiver(s) explain:

How the research involves no more than minimal risk to participants:

Why the waiver will not adversely affect the rights and welfare of participants:

Why the research could not practicably be carried out without the waiver:

Whether participants will be provided with pertinent information after the study ends:

Appendix

Waiver or Alteration of HIPAA Authorization

A.USE OF PROTECTED HEALTH INFORMAITON (PHI)

The Federal Privacy Rule allows the IRB to waive the authorization requirement for use of PHI

(45 CFR 164.512 (i)(2)(ii)), provided that the IRB determines and documents that:

The use of PHI involves no more than minimal risk to privacy.

Describe your plan to protect the identifiers from improper use or disclosure:

Describe your plan to destroy identifiers at the earliest opportunity or justify why you plan to retain identifiers:

The research could not practicably be conducted without the waiver.

Please explain, in detail, why this research could not be conducted without a waiver of the requirement to obtain authorization:

The research could not practicably be conducted without access to and use of PHI.

Describe the specific PHI to be used:

Why is use of PHI necessary for this research?

B.DISCLOSURE OF PHI (to organizations or persons outside of MCRF)

The Federal Privacy Rule allows the IRB to waive authorization requirement for disclosure of

PHI (45 CFR 164.512 (i)(2)(ii)) provided that the IRB determines and documents that:

1.The disclosure of PHI involves no more than minimal risk to privacy.

Describe your plan to protect the identifiers from improper use or disclosure:

Describe your plan to destroy identifiers at the earliest opportunity or justify why you plan to retain identifiers:

2.The research could not practicably be conducted without the waiver.

Please explain, in detail, why this research could not be conducted without a waiver of the requirement to obtain authorization:

3.The research could not practicably be conducted without access to and use of PHI.

a. Describe the specific PHI to be disclosed.

b. Why is disclosure of PHI necessary for this research?

Appendix

Interviews, Surveys, Questionnaires, and or Focus Groups

Does this research involve focus groups?

No

Yes - describe how the identity of individuals participating will be protected:

Does this research involve interview(s), survey(s) or questionnaire(s)?

No

Yes - indicate in what manner the survey, interview or questionnaire will be conducted (check all

that apply):

In person -describe the location:

Internet – Complete Appendix - Internet-Based Research

Mail

Telephone

Other - specify:

Is information that is potentially distressing or likely to impose social or psychological risks being collected?

No

Yes - answer the following and submit the data collection tool:

Justify why this information is necessary:

Describe your plan for minimizing and managing this risk:

Submit a copy of the data collection tool

Appendix

Transnational Research

International institution(s) at which research is being conducted or identifiable data are being collected:

Country(ies):

Name and address for international project IRB correspondence:

Provide justification for conducting the research internationally as opposed to domestically:

Describe why the particular location(s) has been selected to conduct the research:

Describe whether cultural, economic, or political conditions of the country or countries would alter the risk for participants compared to the same research conducted within the U.S.:

Describe any special cultural considerations for obtaining informed consent (e.g., community consent, presence of elders, etc.):

Is this project federally funded?

No

Yes - Provide the international site(s)’ Federal Wide Assurance (FWA) number. If the

site does not have an FWA, please state this. NOTE: If the study is federally funded,

an FWA is required. If the site does have an FWA, all key personnel from the site must

be listed in this application.

Please attach the following:

Documentation of IRB or International Ethics Committee (IEC) approval, or equivalent

Letter of support from an appropriate institutional official at the site of the research

Additional letters of support or approval from relevant health or governmental

Authorities.

Appendix

Research with Existing Human Specimens

What was the original reason for the collection of these biological specimens?

Standard clinical care

Research (specify)

Specimens were collected as part of an IRB-approved protocol at Marshfield Clinic (provide the SP Code).

Did subjects provide informed consent as part of the original specimen collection?

No

Yes

What did the consent form say the specimens would be used for?

Specimens were collected as part of a protocol approved by an external collaborator’s IRB

Did subjects provide informed consent as part of the original specimen collection?

No

Yes

What did the consent form say the specimens would be used for?

Other (Describe):

APPENDIX

Creation of a Research Bio-Bank

Indicate the types of biological specimens to be collected and/or used (Select all that apply):

Blood

DNA

Tissue

Urine

Other - identify:

For Bio-specimens in Existence Prior to Proposed Research:

What was the original reason for the collection of these biological specimens?

Clinical care

Research

Other - identify:

Not Applicable

If you selected "Research" above, answer the following:

Were the specimens collected as part of an IRB-approved protocol at Marshfield Clinic?

No

Yes- provide the SP Code or IRB study number:

Were the specimens collected as part of a protocol approved by an external collaborator’s IRB?

No

Yes - identify the collecting institution:

Did research participants provide informed consent as part of the original specimen collection?

No

Yes - describe what the informed consent document stated that the specimens would be used for:

For Prospective Collection of Biological Specimens with Consent From Participants:

Describe the method of collecting biological specimens:

Venipuncture

Buccal swab/sputum collection

Nasal swab

Bone marrow aspirate

Surgical biopsy

If surgical biopsy is selected, specify:

Other – specify:

Not Applicable - Previously existing specimens

Will participants be able to withdraw their specimens?

Not applicable

Yes

No - indicate why:

Specimen will be completely anonymized allowing no way to identify individuals

Other - explain:

Describe the procedure for reviewing and approving requests for use of the banked bio-specimens by:

Marshfield Clinic researchers:

External researchers:

Appendix

Creation of a Research Database

What information will the database contain:?

Describe the source(s) of the data:

Describe the procedure for collecting the data:

What protections are in place to protect confidentiality:

Patient records stored in a de-identified way, eliminating linkage to unique identifiers (inter-file

linkage)

PHI elements obfuscated or “fuzzed”

PCs used in data collection equipped with encrypted hard drive

Data entry tools and databases maintained behind firewalls

User-level password-protected data entry

Shared login password-protected data entry

Audited data access to research data warehouse

Paper records locked in a secure location

Certificate of Confidentiality issued by a DHHS agency

Error inoculation (inserting random error into dataset to secure confidentiality while still

allowing useful statistical analysis)

Top coding (replacing values above a certain level with a threshold value)

Use of an Honest Broker (a third party holds the data and identifiers)

Where will the data be stored:

How will the data be protected:

Describe the procedure for reviewing and approving requests for use of the banked data by:

Marshfield Clinic researchers:

External researchers:

Appendix

Adults Lacking Capacity to Consent

This request is to:

Recruit decisionally impaired adults to study the condition leading to, or the state of their

impairment

Enroll decisionally impaired adults onto a study of an investigational treatment for an

unrelated condition

Provide justification for including this population; please describe why it is both necessary as well as important to include this vulnerable population:

Who will determine the participants' capacity to consent?

Describe the process to be used to determine the capacity to consent, including any instruments that will be used:

What specific steps will you take to ensure that these vulnerable participants will not be subject to coercion or undue influence regarding participation?

Is it likely that this research will alter ongoing therapy or treatment for participants’ impairment?

No

Yes

Not applicable

Are you requesting that a Legally Authorized Representative (LAR) be allowed to provide consent for the decisionally impaired participant?

No - explain:

Yes - how will this LAR be identified and documented?

Will verbal assent be obtained from the decisionally impaired participant?

No

Yes

If you answered "No," justify why not. If you answered "yes," describe the process to be followed:

If capacity is expected to fluctuate during research participation, describe the process for determining ongoing consent:

N/A

Version – April 25, 2016

Version – June 1, 2014

Page 38 of 38

PHI is Information that relates to the past, present, or future physical or mental health or condition of an individual (including the provision of health care to an individual or payment for the provision of health care) which identifies the individual or to which there is a reasonable basis to believe the information can be used to identify the individual. PHI includes demographic information.

To be considered PHI, information must contain one of the following HIPAA identifiers: name, DOB, dates of specimen collection or treatment, address, phone number, FAX number, MHN, SSN, email addresses, health plan ID numbers, account numbers, device identifiers and serial numbers, certificate or license numbers (including license plates), vehicle identification numbers, URL’s IP addresses, biometric identifiers, full face or comparable images, unique codes created from an individual’s identifiable information.

Scheller, Lori A

2016-12-15

Knecht, Justin E

Marshfield Clinic