NYS DEPARTMENT OF HEALTH INSTITUTIONAL REVIEW BOARD FORM 1871 (a)

PROTOCOL REVIEW REQUEST FORM -- APPLICATION INSTRUCTIONS

Complete the DOH 1871 form using the instructions below. Be sure the DOH 1871 form is endorsed by your Center Director or appropriate Institutional Official.

Study Title: indicate the actual title of the research study being submitted for review and approval.

Grant Title: indicate the title of the grant that funds the study, if applicable.

Principal Investigator(s): list the Investigator who will be responsible for the overall conduct of the study, then list all co-investigators who will be involved with the study.

IRB Training Completed: indicate whether the Investigators have completed an approved course in the protection of human subjects in research. Include a copy of the certificate in the application package.

List Other Institutions Involved: indicate No or Yes. Include the name of the collaborating institution(s) in the space provided. If the study is federally funded, provide the FWA # of the collaborating/contracting institution and include a copy of the OHRP approval in the protocol application. If the collaborating institution/individual does not have an FWA #, include an Authorization Agreement or an Individual Investigator Agreement.

Other Institution’s IRB Approval: If applicable, indicate No, Yes, or In Progress based on the status of approval at the collaborating institution(s) at the time of submission. Note that this approval must be provided prior to the initiation of approved study activities.

Sponsor: provide the name of the funding agency for the research, ex. CDC, NIH.

Grant Number: provide the HRI Grant Number corresponding to the Grant Title requested above.

Employee Of: check the box corresponding to the Principal Investigator’s, Co-Investigator’s and Study Coordinator’s employer. Mark all that apply.

Anticipated Start Date: indicate the date on which the study is expected to commence.

Reason for Applying to the IRB: indicate the level/type of review that is being sought. It is strongly suggested that you indicate the proper level of review in order to avoid delay in the processing of your request. IRB staff will make corrections if an incorrect category is chosen. Contact the IRB for guidance on identifying the appropriate review category (518) 474-8539.

Page 1 of 4

DOH-1871 (a) 1/14 Check all that apply to your research study: check the appropriate categories that identify populations to be included in the research. The IRB is made aware of the need to invoke any additional protections such as in the case of research with prisoners, minors, the mentally incapacitated or pregnant women.

Investigational Drugs Devices and Biologics: INDs/Investigational Drug name(s) and IDEs/Investigational Device name(s). Indicate in this section the numbers and names of any investigational new drugs (INDs) or Investigational Device Exemptions (IDEs) involved in the research. If your study is a Drug/Biologic (IND study, a copy of the following is required:

 Investigator’s Drug Brochure  Background Information for Food Supplements  FDA Form 1572 (if applicable)  FDA approval or exemption letter

If your study is a Device (IDE) study, a copy of the signed Investigator Agreement for protocols with an IDE, and ONE of the following:

 FDA letter granting the Investigational Device Exemption (IDE) or  Letter from sponsor stating that the study is a non-significant risk device study or  Letter explaining why the investigation is exempt from the IDE requirements under 21 CFR 812.2 or otherwise exempt

Conflict of Interest: Check YES or NO. The PI must divulge if anyone connected with the study (including immediate family members) has a potential financial conflict of interest as defined by institutional policy. If so, for each individual with a potential financial conflict of interest the protocol should describe: the nature of the potential conflict, proof that the conflict been reported to appropriate institutional officials, and explain how will the conflict be managed?

Each identified PI to this protocol MUST attach a signed Form DOH-3995 (Disclosure of Reportable Interest in Research Project)

Expected # Subject Enrollment: List the maximum number of subjects (records) that will be accrued/reviewed.

A. EXEMPT

Mark the checkbox that is appropriate for your study in Section A. Attach the protocol and any other supporting documents. This type of study can be submitted for review at any time and will be reviewed by the IRB Chair or Executive Secretary.

An original and one copy of all study documents are needed for IRB review.

Page 2 of 4

DOH-1871 (a) 1/14 B. EXPEDITED REVIEW

Research activities involving no more than minimal risk to human subjects, and that involve only procedures listed in one or more of the categories listed in Section B may be eligible for the Expedited Review procedure. The Expedited Review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Attach the protocol, informed consent form(s), a description of how consent will be obtained, a copy of other IRB approval(s) and any other necessary documents to the form.

An original and 5 copies of the entire package must be submitted to the IRB. Expedited proposals are accepted and reviewed as received.

C. FULL REVIEW

Any study involving greater than minimal risk or involving a vulnerable population (as outlined in Subpart B, C, D of 45 CFR 46) must receive Full Review by a quorum of all IRB members in attendance at a Full Board meeting. The protocol should reflect that the PI is knowledgeable of the federal regulations pertaining to the additional protections required for this class of research subject. Information on protected classes of research subjects can be found on the Department of Health and Human Subjects website: www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

Attach the protocol, informed consent and/or parental permission form(s), child assent form (if applicable), a description of how consent will be obtained, a copy (or copies) of other IRB approval(s) and any other necessary documents to the form.

An original and 18 copies of the entire package should be submitted to the IRB three week prior to the next scheduled bi-monthly IRB meeting. Refer to the IRB schedule for deadlines and meeting dates.

D, E & F. REGISTRY/VITAL RECORDS REQUESTS

Each registry has its own procedures for information/data requests. Check with the contact person listed in the DOH Guidelines to determine where to apply for information/data from a particular registry. Vital Records requires IRB Full Board approval for some proposals seeking birth certificate information. Follow the instructions for Full Board approval for Vital Records requests and mail your package to them.

Page 3 of 4

DOH-1871 (a) 1/14 G. FIVE YEAR REVIEW

In addition to the continuation review, studies must reapply to the IRB for approval every five years. Apply to the IRB using the DOH 1871 form as if applying for a new study and follow the instructions that are appropriate to the level of review (Section A, B, C). The following must be included:

 A summary description of subjects’ experience: benefits, adverse events or unanticipated problems, the number and reasons for withdrawal of subjects, and/or complaints about the research.

 Summary of study results thus far.

 Attach any new literature, findings, or other relevant information.

 Copy of the current informed consent document(s).

 Any planned changes in the conduct of the study.

 Updated human subject’s protection training certificates

H. REQUEST TO REOPEN CLOSED/EXPIRED STUDY

Mark the checkbox that is appropriate for your CLOSED or EXPIRED study in Section A (Exempt) or Section B (Expedited Review). Attach the study protocol and any other supporting documents. Include any amendments that may have been applied to the protocol between the time it was closed and the present. The narrative description must include the reason for reopening the CLOSED Study or why the EXPIRED Study was allowed to expire. This request can be submitted for review at any time and will be reviewed by the IRB Chair, Executive Secretary or Subcommittee, as appropriate given the level of risk. A study that was originally reviewed by the Full Board will be presented to the Full Board for consideration.

ENDORSEMENTS:

The Principal Investigator (PI) is fully responsible for the conduct of all aspects of his/her IRB approved protocol. Due to the significance of this responsibility, the IRB will only accept protocol paperwork that has been signed by the PI. Paperwork signed by a Co-Principal Investigator (Co-PI) will not be accepted, and will be returned to the sender/PI. The signature of the appropriate Center Director, or an Institutional Official (IO), who is legally authorized to act on behalf of the institution, is required. Once IRB approval has been granted, the application will be signed by the IRB Chair, Executive Secretary or Program Director.

Page 4 of 4

DOH-1871 (a) 1/14