Comirb Reviewer Protocol Checklist

Boston College Institutional Review Board Office for Research Protections 140 Commonwealth Avenue, Waul House Chestnut Hill, MA 02467 IRB Member Checklist - Initial Review (617) 552-4778 Fax: (617) 552-0498 E-mail: [email protected] Expedited or Full Board Review

Instructions: This checklist may only be altered in the grey boxes. To complete the form, directly “click” on the grey areas or use the “tab” button on your keyboard to advance through the questions.

Reviewer: Date of Review: Principal Protocol

Investigator: Number: Faculty Sponsor: Advisor: Study Design/Methods Blinding Qualitative Research Double Quantitative Research Single Oral History Evaluator Controlled None Randomized Therapeutic Intent Other:

Invasive Procedures : Blood Draw surface recordings ultrasound Participant Age Range: (see IRB Application Other: Please explain Question 6) Are they Adequately Justified: Yes No Please Note: X-rays/radiographs not allowed in expedited review Major Ethical Concerns: Risk Assessment: Minimal Risk Greater than Minimal Risk (requires full board review)

What type of risks are most likely (psychological, physical, economic, breech of confidentiality, stigma, loss of status, perceived loss of status, loss of benefits, etc.):

Potential Benefits: Generalizable knowledge Improve treatment or system Decrease existing risk or hazards Reduce costs Other (Please identify):

Vulnerable Research Subjects: Enrolling vulnerable research subjects requires additional protections. Check each category of subjects listed below that will be enrolled in this research study:

Student Employee Client Pregnant women/fetuses Children Economically or educationally disadvantaged Prisoners (full board only) Mentally/Cognitively Impaired Outpatient Inpatient No vulnerable subjects Not applicable – existing data or specimens

Expedited Research Categories: Please check all that apply

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

(a) Research on drugs for which an investigational new drug application (21 CFR Part 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.)

(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 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.

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

BC IRB Expedited Reviewer Checklist Protocol Number Page 1

Rev. 01/19/10 Reviewer’s Initials Date

(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, 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; or

(b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, 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.

(3) Prospective collection of biological specimens for research purposes by noninvasive 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.

(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 subject or an invasion of the subjects 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.

(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 subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

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

(7) Research 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 subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.

(8) Continuing review of research previously approved by the convened IRB as follows:(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or(b) where no subjects have been enrolled and no additional risks have been identified; or(c) where the remaining research activities are limited to data analysis.

(9) Continuing review of research [INITIALLY A FULL BOARD REVIEW], not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. None of the above categories apply. Requires Full Board review.

Reviewer Protocol Checklist Comments

A. Investigator Qualifications: Is the investigator qualified to conduct the research (they have completed human participant training, coursework on research or have actual experience with this type of research)? Yes No

Is there a conflict of interest? Yes No

B. Coercion: Does the recruitment/consent process include any possible Influence or coercion that unduly entices participation? Yes No

Examples: excessive compensation, unequal relationship [provider-patient, employer- employee, faculty-student) please defer to full board if potential for coercion is substantial

C. Sensitive information: Does the protocol broach sensitive subjects? Yes No

Examples: child abuse, violence; some infectious diseases; report of conditions could affect insurability, compensation, economic standing, employability or litigation (civil or criminal).

D. Stigmatization/Loss of Service: Does participation in the protocol put a participant at risk of loss of insurance or entitled services, social or self stigma, screening or diagnosis of diseases with significant potential for loss of insurance or other services( e.g., carrier of an incurable genetic disease, HIV) ? Yes No

E. Genetic research: Does the protocol propose genetic research and research using blood and other body tissues? Yes No

Risks of genetic research include stigmatization, self-stigmatization, loss of insurance, discovered misattributed paternity, etc. The protocol must (1) omit identifiers, or inform subjects of all risks and (2) not grow perpetual cell lines or disclose that prospect in the consent form allowing subjects to opt out of growing cells.

F. Deception: Does the protocol include any elements of deception? Yes No Major: mislead subjects about their health status, the researchers, or research purpose. Minor: incompletely disclose some purpose of the study to avoid biasing the results.

G. Radioactive Drugs/Recombinant DNA: Are radiation or recombinant DNA used in this research? Yes No

H. Consent Process: Are the procedures adequate to inform and negotiate consent? Yes No

Does the protocol adequately describe the following consent processes: 1. How the person obtaining consent will be trained? Yes No 2. The setting in which consent will be obtained (does the subject have adequate time to consider and is environment appropriate? Yes No 3. How the subjects’ autonomy and comprehension is assessed? Yes No 4. A copy of the consent form is provided to the subject? Yes No

I. Types of consent waiver not allowable in expedited research: Use of proxy consent, or emergency research waiver of consent requires full board review. Are either of these proposed? Yes No

J. Waiver of Consent or Elements of consent : Does the protocol propose waiver of informing the subjects and obtaining consent? Yes No If NO, proceed to question M

Category I (45 CRF 46.116 (c)) 1. The research project is to be conducted by, or subject to the approval of state or local government officials, and is designed to study, evaluate, or otherwise examine (i) public benefit or service programs; (ii)procedures for obtaining benefits or services under those programs; (iii)possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs and 2. The research could not practicably be carried out without the waiver OR Category II (45 CFR 46. 116 (d)) ALL MUST APPLY 1. The research involves no more than minimal risk to the subjects; and 2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and 3. The research could not practicably be carried out without the waiver and 4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. Does the protocol meet all the criteria under Category 1 or 2? Yes No

K. Waiver of Documentation of informed consent: Does the protocol propose waiver of the requirement to obtain a signed consent form for some or all subjects? If NO, proceed to question M.

1. The IRB may waive the requirement to obtain a signed consent form (45 CFR 46.117(c) IF:

1. The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern OR 2. The research presents no more than minimal risk of harm to subjects, and involves no procedures for which written consent is normally required outside of the research context.

Does the protocol meet the all criteria described in #1 or #2? Yes No

L. Subject selection: Is the selection of subjects equitable? Yes No Not Applicable If any group is excluded, is there adequate justification? Yes No

M. Confidentiality: Are the procedures adequate to maintain confidentiality, anonymity, security and privacy of the subjects? Yes No

1. Will the non-computer data be held in a secure manner? Yes No 2. Will the computer data be held in a secure manner? Yes No 3. Is a certificate of confidentiality to be used? Yes No

N. HIPAA: Is the PI recruiting at a site that may be covered by HIPAA Privacy Protections? Yes No Not Applicable

Has the PI received Authorization for research evaluation? Yes No

Has the PI received a Waiver of Authorization? Yes No

P. Study Materials: Are there study materials described in the protocol? (advertisements, questionnaires, video)? Yes No

If YES, are they submitted for review? Yes No

Q. Compliance Reporting: Should BC IRB validate reports of compliance from sources additional to principal investigator? Yes No

Examples: BC IRB site visit to PI, impartial observer to consent process

R. Continuing Review Interval: What is the appropriate interval for continuing review for this project? 12 MOS. 6 MOS. OTHER Consent Review Checklist Comments Instructions: If a consent form is provided, please evaluate the following required elements of consent. If no consent form is included, but should be created by the PI please note this on the last page of the review check list.

Does this protocol meet criteria for waiver of consent? Yes * No *If yes, and the waiver request is acceptable, then an informed consent form is not required. Go to the last page of the Checklist.

If the PI has requested a partial waiver of consent, all elements except the waived components must be present in the consent form. Please evaluate the consent form for the following element noting which elements have been waived.

A. Research purposes (i.e., protocol’s objectives) are clearly stated.* Yes No

B. A statement that the study involves research “You are being asked to take part in a research study” or similar statement. Yes No

C. Selection of Subjects

A statement is included about why the subject is being asked to participate (PI should NOT list inclusion/exclusion criteria)? Yes No

Number of subjects to be recruited at this site

D. Procedures paragraph begins: Yes No “If you agree to participate, you will be asked to…” or similar statement

E. Procedures All procedures or treatments to be done are described in the research summary and application? Yes No

F. Expected duration of subject participation? Yes No

G. Experimental treatments

Which procedure(s) or treatment(s) that are experimental are clearly stated Yes No Not Applicable

H. Risks/Discomforts A description of reasonably foreseeable discomforts? Yes No

I. Unforeseen risk: The following statement or similar content included “The study may include risks that are unknown at this time.” Yes No

J. The Alternatives ( for protocol including treatment only)

The alternative to the research’s diagnostic method or treatment are clearly stated Yes No Not Applicable

K. Benefits –one of the following statements or similar content must be used:

Non-therapeutic Research Is the following statement or similar content included “This study is designed for the researcher to learn more about [subject of research]. This study is not designed to treat any illness or to improve your health.” Yes No Not Applicable

Therapeutic Research Is the following statement or similar content included “If you decide to take part in this study, there is no guarantee that your health will improve.” Yes No Not Applicable

L. Financial factors Any extra costs are clearly stated? Yes No Not Applicable

M. Sponsor/funding The sponsor is listed? Yes No Not Applicable

N. Subject payment A statement that subjects will be compensated or not compensated, and if compensated and they withdraw from the study, the compensation will be pro-rated? Yes No Not Applicable

O. Study Withdrawal Is the following standard statement or similar content included:

General Research There should be a statement discussing when the investigator may withdraw the subject from the study (i.e. when it is in the subject’s best interest, untoward side effects, failure to comply with the study requirements, closure of the study by the sponsor, etc.) Yes No

Therapeutic Research “Taking part in this study is voluntary. You have the right to choose not to take part in this study. If you do not take part in the study, your doctor will still take care of you. You will not lose any benefits or medical care to which you are entitled. If you choose to take part, you have the right to stop at any time. If there are any new findings during the study that may affect whether you want to continue to take part, you will be told about them. The study doctor/researcher may decide to stop your participation without your permission, if he or she thinks that being in the study may cause you harm, or for any other reason. Also the sponsor may stop the study at any time.” Yes No

P. Invitations for questions: The following standard statements or similar contents are required:

“The researcher carrying out this study is [investigator name]. You may ask any questions you have now. If you have questions later, you may call [contact name] at [phone number]. You will be given a copy of this form to keep. If you have questions regarding your rights as a research subject, please call the Boston College Office for Research Protections at (617) 552- 4778.”

Is this statement or similar content included? Yes No

Q. Confidentiality: The following statement or similar content required:

“We will make every effort to keep your research records confidential, but it cannot be assured. Records that identify you and the consent form signed by you, may be looked at by a regulatory agency such as:  Federal Agencies overseeing human subject research  Boston College Institutional Review Board” Is this statement included? Yes No

“The results of this research may be presented at meetings or in published articles. However, your name will be kept private”. Is this statement included? Yes No Not applicable

SPONSORED RESEARCH ONLY “Your records may also be looked at by [name of the study sponsor] and [name of an agent for the sponsor-if applicable]. “ Is this statement included: Yes No Not applicable

F. Standard Authorization statement: Is the following statement or similar contents Included? Yes No

“I have read this paper about the study or it was read to me. I understand the possible risks and benefits of this study. I know that being in this study is voluntary. I choose to be in this study: I know I can stop being in the study and I will still get the usual medical care. I will get a copy of this consent form.”

R. General Issues: The subjects must be able to understand the consent information. The suggested Reading level is at 8th grade. As written is the consent form likely to be understandable to the subject? Yes No

Additional Reviewer Comments

Application:

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Questionnaires or Research Instruments:

Consent Form: Have you provided an edited consent form? Yes No

Other Comments: Reviewer Approve. Recommendation: Approve with Scripted Changes. Return to Reviewer When Changes are Made. Defer to Full Board.

Please specify Changes or revisions: