Frequently Asked Questions

When do I need to submit a proposal to the IRB?

All proposed research that involves the use of human subjects requires review and approval by the IRB prior to grant submission (if applicable) and initiation of research.

What is research?

Research is defined by the federal regulations as "a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge."

What form(s) are needed to apply to do a study involving human subjects?

The most current version of the IRB Protocol Review Request Form (DOH 1871), along with several other documents depending on the research project is required for initial protocol review. Refer to the document "What PIs need to submit with a New Research Proposal" located on IRBNet.org under the Forms and Templates tab. The Principal Investigator and Center Director must sign the package in IRBNet before the Research Project will be reviewed. If you are not registered on IRBNet, please contact the IRB Office at 518- 474-8539 for information on how to register and receive the IRBNet Training Guide.

Is some research exempt from review?

No! All human subject research must be reviewed. There is a category of research called "Exempt" which means that an IRB Chair has reviewed the research protocol and determined that it falls into one of eight Exempt categories of research (for example, anonymous surveys generally fall into an exemption category). *Please note: Categories 7 & 8 are NOT currently being used by the New York State Department of Health Institutional Review Board. Only the IRB can determine whether a particular research project meets the Exemption Categories.

If my research is not funded -- do I still need IRB approval?

Yes, it still needs to be reviewed. Based on the level of risk to subjects, your protocol will be reviewed as Exempt, Expedited or Full Board.

What is minimal risk?

The Office for Human Research Protections (OHRP) defines Minimal Risk as:

"The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

What is informed consent?

Informed Consent is central to the ethical conduct of research. It is an on-going conversation between the research subject and the researchers which begins before consent is given and continues until the end of the subject's involvement in research.

The Informed Consent document is a written summary of the mandatory information that is provided to the research subject. Many investigators use the Informed Consent document as a guide for the verbal explanation of the study. The research subject's signature provides documentation of agreement to participate in the study, but the research subject is free to withdraw from the study at any time without consequences. The Revised Common Rule has general requirements for Informed Consent whether written or oral that must be followed (§46.116).

The informed consent document must contain the basic elements of informed consent as identified in and required by the US regulations regarding the protection of human subjects (45 CFR 46). As required by this regulation, the informed consent must be reviewed and approved by an Institutional Review Board. There is an Informed Consent Template in IRBNet.org under the Forms and Templates tab for reference.

Who makes up the IRB?

The IRB has members from diverse fields including medicine, law, genetics, epidemiology, education, and pharmacy, as well as the community. Members are drawn from within and outside the New York State Department of Health.

Can I attend IRB Meetings while my study is being discussed?

IRB Meetings are not open to the public. However, the Principal Investigator(s) and appropriate research staff may be invited to attend the meeting to answer questions or offer clarification regarding their applications. PIs will be notified at least one week prior to the relevant meeting if your attendance is required. Only IRB members and administrative staff are permitted to attend the meeting during the time votes are taken.

Why does the review process sometimes take so long?

The review of applications that involve human subjects in research is a multi-step process. The process begins with the submission of an application to the IRB's Administrative Office. The initial application is then screened by IRB Administrative Staff. If clarification is needed or there are missing documents, IRB Administration Staff will communicate what is needed to the Principal Investigator (PI). Once the PI responds and submits or revises the necessary documents and the screening has been completed, the package is submitted to: 1) the IRB Chair for Exempt study reviews, 2) Expedited Review Subcommittee for Expedited Criteria Studies, or 3) the Full Board. During the review process, the IRB Chair, Expedited Review Subcommittee and/or Full Board examines the protocol and supporting documentation to ensure that the investigator has addressed the risks and benefits posed to potential subjects participating in the research, the subject selection is equitable, and that the consent process will provide adequate information to prospective subjects so that subjects can make an informed decision regarding their participation in the research activity. Any issues or concerns identified during the IRB review will be communicated to the investigator, and the investigator will be given thirty days to respond.

How long will it take before I receive approval from the IRB?

All approvals will be granted in writing. Generally, protocols without stipulations are reviewed according to the following timeline:

  • Exempt Review (from completion of screening by the IRB office to granting of exemption): within10 business days
  • Expedited Review (from completion of screening by the IRB office to approval): within 15 business days
  • Full-Board Review (days after a committee meeting): within 10 business days

What is the difference between Full, Expedited, and Exempt review?

Full-Board Review

Studies are reviewed by a fully-convened IRB meeting at a scheduled meeting. The members discuss the study and makes a decision. This type of review is carried out for studies greater than minimal risk to subjects or involving protected classes as defined by 45 CFR 46 Subparts A-D.

Expedited Review

Studies are reviewed by a 3-5 panel Subcommittee designated by the IRB . The members review the appropriate materials and consults with the PI if necessary, to come to a decision about approval of the study. This type of review is for studies that involve minimal risk to subjects and fit into the Expedited Review Criteria of research.

Exempt review

If a study fits into an Exempt category of research and presents minimal risk to subjects, the IRB Chair, Vice Chair or IRB Designee can review these studies.

How do I answer stipulations from the IRB?

The Principal Investigator must submit a written response to the IRB Chair within thirty days from the initial request for additional information or revisions. The resubmission should include any missing or revised documents requested, e.g. revised documents with tracked changes, as well as, a clean copy of each document revised. Include all documents or information requested by the committee.

Does student research require IRB review?

Yes, if the student is employed by DOH/HRI and/or the project is funded by DOH/HRI. In addition, if students are conducting research as part of a class assignment; or as part of the requirement for a SUNY Albany School of Public Health degree program; and the research involves human subjects, records gathered on human subjects, or human tissue, then the IRB must review the proposed research.

Does a data set gathered for another purpose but applied in a new research project require review?

Yes. Projects that use data on human subjects gathered in earlier projects require IRB review. If the data are gathered by someone who has legitimate access to the records and who gives the investigator only "blinded" or de-identified data (so that the investigator is unable to identify the subjects), the level of risk is lowered.

Is an English consent document OK when enrolling non-English- speaking subjects?

In order to meet the requirements of 45 CFR §46.116 and §46.117, the consent document must be in language understandable to the research subject. When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English. Whenever the size of a non-English-speaking subgroup is expected to exceed 5% of the population included within the study and the sample is expected to include 150 or more members of the subgroup, the study's survey instruments and materials must be translated into the appropriate language. Whether the interview is conducted in person or by telephone, you must use bilingual interviewers who are fluent in English and the other language. The IRB also requires an attestation from the translator certifying the accuracy of the translation of the other language. Attestations are found on IRBNet.org under the Forms and Templates tab.

If investigators are uncertain whether non-English speaking subjects might be enrolled in a study or believe there might be a very small number of subjects (< 5%) who will not understand English, the regulations allow the use of a short form (in the subject's language) and a summary document (in English).

Who should be listed on the consent form as the contact to answer questions?

The Principal Investigator or other knowledgeable person should be named to answer questions about the research. The NYSDOH IRB requires that the IRB Program Director be listed as the contact for questions regarding study subjects' rights.

Sample language:

"If any problems or questions arise about the study, call Dr. XXXXXXXX at 800-444-1111. If you have any questions about your rights as a research subject, you may call Tony Watson, Administrative Director, at (518) 474-8539."

Who should be present when an informed consent interview is conducted?

OHRP does not require a third person to witness the consent interview unless the subject or representative is not given the opportunity to read the consent document before it is signed; (see 21 CFR 50.27(b)). The person who conducts the consent interview should be knowledgeable about the study and able to answer questions.

If someone other than the Principal Investigator conducts the interview and obtains consent, this responsibility should be formally delegated by the PI and the person so delegated should have received appropriate training to perform this activity.

The NYSDOH IRB has the authority to observe ALL Informed Consent interview procedures to assure compliance with approved procedures.

Do I need human subjects' protection training?

Human Subjects' Protection Training is required for all Principal Investigators and research personnel who conduct human subjects research. Human subjects' protection training for all personnel involved with a study must be completed and documented before IRB approval is granted. Current human subjects' protection training consists of completing an initial educational requirement and renewing the educational requirement prior to the training expiration date.

How do I receive Human Subjects' Research Protection Training?

NYSDOH IRB offers CITI training: The Collaborative IRB Training Initiative (CITI) is a web-based training program in human research subjects' protection for all DOH employees. A five-year certificate will be issued for completion of this training program. CITI can be accessed at http://www.citiprogram.org.

Can my Institution create a Human Research Review Committee (HRRC) in New York State?

Yes. Under Public Health Law Article 24-A, Section 2444:

  1. Each public or private institution or agency which conducts, or which proposes to conduct or authorize, human research, shall establish a human research review committee. Such committee shall be composed of not less than five persons, approved by the commissioner, who have such varied backgrounds as to assure the competent, complete and professional review of human research activities conducted or proposed to be conducted or authorized by the institution or agency. No member of a committee shall be involved in either the initial or continuing review of an activity in which he has a conflicting interest, except to provide information required by the committee. No committee shall consist entirely of persons who are officers, employees, or agents of, or who are otherwise associated with the institution or agency, apart from their membership on the committee, and no committee shall consist entirely of members of a single professional group.
  2. The human research review committee in each institution or agency shall require that institution or agency to promulgate a statement of principle and policy in regard to the rights and welfare of human subjects in the conduct of human research, and the committee and the commissioner shall approve that statement prior to its taking effect. The committee shall review each proposed human research project to determine (a) its necessity; (b) that the rights and welfare of the human subjects involved are adequately protected, (c) that the risks to the human subjects are outweighed by the potential benefits to them or by the importance of the knowledge to be gained, (d) that the voluntary informed consent is to be obtained by methods that are adequate and appropriate and, (e) that the persons proposed to conduct the particular medical research are appropriately competent and qualified. The committee shall periodically examine each existing human research project with regard to the proper application of the approved principles and policies which the institution or agency has promulgated. The committee shall report any violation to the commissioner. In addition to the voluntary informed consent of the proposed human subject as required by section 2442 of this chapter, the consent of the committee and the commissioner shall be required with relation to the conduct of human research involving minors, incompetent persons, mentally disabled persons and prisoners.
  3. Each person engaged in the conduct of human research or proposing to conduct human research shall affiliate himself with an institution or agency having a human research review committee, and such human research as he conducts or proposes to conduct shall be subject to review by such committee in the manner set forth in this section.

Is a HRRC different from an IRB?

Not necessarily. An existing IRB or a committee that functions like an IRB, may be established as an HRRC

What are the key requirements for establishing a HRRC?

The key requirements include committee composition and membership number minimums. The minimum number of people required for an HRRC is five; however, you can certainly have more than five members. The number of members will most likely depend on the size of the institution and the HRRC workload. The availability of potential members will also affect the number of members you choose to have on your HRRC.

Your institution may have more than one HRRC. Some Institutions may wish to have multiple HRRCs that specialize in particular types of research.

The Composition of the HRRC must consist of a minimum of five members of varied backgrounds to facilitate diversity in its composition and to assure the competent, complete and professional review of human research activities conducted or proposed to be conducted or authorized by the institution or agency. One member must come from outside the institution and not be affiliated with the institution. The HRRC should not have representation from just from one profession.

Does the HRRC need to have policies and procedures to conduct Human Subjects Research?

The Human Research Review Committee (HRRC) in each institution or agency shall require that institution or agency to promulgate a statement of principle and policy in regard to the rights and welfare of human subjects in the conduct of human research, and the committee and the commissioner shall approve that statement prior to its taking effect.

The HRRC shall review each proposed human research project to determine:

  1. its necessity;
  2. that the rights and welfare of the human subjects involved are adequately protected,
  3. that the risks to the human subjects are outweighed by the potential benefits to them or by the importance of the knowledge to be gained;
  4. that the voluntary informed consent is to be obtained by methods that are adequate and appropriate, and
  5. that the persons proposed to conduct the particular medical research are appropriately competent and qualified.

The committee shall periodically examine each existing human research project with regard to the proper application of the approved principles and policies which the institution or agency has promulgated.

Who approves the HRRC, their membership, and policies and procedures?

The HRRC and its membership MUST be approved by the NYS Commissioner of Health or their Designee.

The Statement of Principle and Policy MUST be approved by the NYS Commissioner of Health, or their Designee.

What if the HRRC has an Adverse Event?

The HRRC MUST report any Adverse Events to the NYS Commissioner of Health, or their Designee.

What if an HRRC study involves vulnerable populations?

In addition to the voluntary informed consent of the proposed human subject as required by Public Health Law Article 24-A, Section 2444, the consent of the committee and the commissioner shall be required with relation to the conduct of human research involving minors, incompetent persons, mentally disabled persons and prisoners.